Trial Outcomes & Findings for Comparative Efficacy and Safety Study of RGB-14-P and Prolia® in Women With Postmenopausal Osteoporosis (NCT NCT05087030)
NCT ID: NCT05087030
Last Updated: 2024-10-24
Results Overview
Percentage change from baseline in lumbar bone BMD was assessed. BMD at the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA). This outcome measure was assessed for main period.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
473 participants
Primary outcome timeframe
Week 52
Results posted on
2024-10-24
Participant Flow
The study was conducted between 21-September-2021 (first subject first visit) to 15-November-2023 (last subject last visit).
A total 473 participants were randomized in this study. The screening period was up to 35 days. ICF was signed prior to screening procedures. Subjects received study drug in a randomized order. All study assessments were performed as per the schedule of assessments.
Participant milestones
| Measure |
Main Period: RGB-14-P
Participants received RGB-14-P as subcutaneous (SC) injection on Day 1 of Treatment Period 1 (Week 0) and Treatment Period 2 (Week 26).
|
Main Period: Prolia®
Participants received Prolia® as SC injection on Day 1 of Treatment Period 1 (Week 0) and Treatment Period 2 (Week 26).
|
Transition Period: RGB-14-P to RGB-14-P
Participants who received RGB-14-P during the main period were re-randomized to receive RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52).
|
Transition Period: Prolia® to RGB-14-P
Participants who received Prolia® during the main period were re-randomized and received RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52).
|
Transition Period: Prolia® to Prolia®
Participants who received Prolia® during the main period were re-randomized and received Prolia® as SC injection on Day 1 of Treatment period 3 (Week 52).
|
|---|---|---|---|---|---|
|
Main Period (Week 0 to Week 52)
STARTED
|
242
|
231
|
0
|
0
|
0
|
|
Main Period (Week 0 to Week 52)
COMPLETED
|
225
|
211
|
0
|
0
|
0
|
|
Main Period (Week 0 to Week 52)
NOT COMPLETED
|
17
|
20
|
0
|
0
|
0
|
|
Transition Period (Week 52 to Week 78)
STARTED
|
0
|
0
|
63
|
62
|
63
|
|
Transition Period (Week 52 to Week 78)
COMPLETED
|
0
|
0
|
63
|
62
|
62
|
|
Transition Period (Week 52 to Week 78)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Main Period: RGB-14-P
Participants received RGB-14-P as subcutaneous (SC) injection on Day 1 of Treatment Period 1 (Week 0) and Treatment Period 2 (Week 26).
|
Main Period: Prolia®
Participants received Prolia® as SC injection on Day 1 of Treatment Period 1 (Week 0) and Treatment Period 2 (Week 26).
|
Transition Period: RGB-14-P to RGB-14-P
Participants who received RGB-14-P during the main period were re-randomized to receive RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52).
|
Transition Period: Prolia® to RGB-14-P
Participants who received Prolia® during the main period were re-randomized and received RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52).
|
Transition Period: Prolia® to Prolia®
Participants who received Prolia® during the main period were re-randomized and received Prolia® as SC injection on Day 1 of Treatment period 3 (Week 52).
|
|---|---|---|---|---|---|
|
Main Period (Week 0 to Week 52)
Withdrawal by Subject
|
8
|
13
|
0
|
0
|
0
|
|
Main Period (Week 0 to Week 52)
Adverse Event
|
2
|
2
|
0
|
0
|
0
|
|
Main Period (Week 0 to Week 52)
Lost to Follow-up
|
3
|
0
|
0
|
0
|
0
|
|
Main Period (Week 0 to Week 52)
Protocol Deviation
|
1
|
0
|
0
|
0
|
0
|
|
Main Period (Week 0 to Week 52)
Death
|
0
|
1
|
0
|
0
|
0
|
|
Main Period (Week 0 to Week 52)
Subject's Personal Reason
|
0
|
2
|
0
|
0
|
0
|
|
Main Period (Week 0 to Week 52)
Exclusion criteria met
|
1
|
0
|
0
|
0
|
0
|
|
Main Period (Week 0 to Week 52)
Study Objective Confounded By Monoclonal Gammopathy
|
1
|
0
|
0
|
0
|
0
|
|
Main Period (Week 0 to Week 52)
Other
|
1
|
2
|
0
|
0
|
0
|
|
Transition Period (Week 52 to Week 78)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Comparative Efficacy and Safety Study of RGB-14-P and Prolia® in Women With Postmenopausal Osteoporosis
Baseline characteristics by cohort
| Measure |
Main Period: RGB-14-P
n=242 Participants
Participants received RGB-14-P as subcutaneous (SC) injection on Day 1 of Treatment Period 1 (Week 0) and Treatment Period 2 (Week 26).
|
Main Period: Prolia®
n=231 Participants
Participants received Prolia® as SC injection on Day 1 of Treatment Period 1 (Week 0) and Treatment Period 2 (Week 26).
|
Total
n=473 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.7 Years
STANDARD_DEVIATION 5.20 • n=99 Participants
|
66.8 Years
STANDARD_DEVIATION 4.91 • n=107 Participants
|
66.7 Years
STANDARD_DEVIATION 5.06 • n=206 Participants
|
|
Sex: Female, Male
Female
|
242 Participants
n=99 Participants
|
231 Participants
n=107 Participants
|
473 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
223 Participants
n=99 Participants
|
209 Participants
n=107 Participants
|
432 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
241 Participants
n=99 Participants
|
229 Participants
n=107 Participants
|
470 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 52Population: The Full analysis set (FAS) included all participants to whom the investigational medicinal product (IMP) has been randomized. Here, 'number of participants analyzed' specifies all participants who were evaluated for this outcome measure.
Percentage change from baseline in lumbar bone BMD was assessed. BMD at the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA). This outcome measure was assessed for main period.
Outcome measures
| Measure |
Main Period: RGB-14-P
n=222 Participants
Participants received RGB-14-P as subcutaneous (SC) injection on Day 1 of Treatment Period 1 (Week 0) and Treatment Period 2 (Week 26).
|
Main Period: Prolia®
n=206 Participants
Participants received Prolia® as SC injection on Day 1 of Treatment Period 1 (Week 0) and Treatment Period 2 (Week 26).
|
Transition Period: RGB-14-P to RGB-14-P
Participants who received RGB-14-P during the main period were re-randomized to receive RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52).
|
Transition Period: Prolia® to RGB-14-P
Participants who received Prolia® during the main period were re-randomized and received RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52).
|
Transition Period: Prolia® to Prolia®
Participants who received Prolia® during the main period were re-randomized and received Prolia® as SC injection on Day 1 of Treatment period 3 (Week 52).
|
|---|---|---|---|---|---|
|
Percentage Change From Baseline (%CfB) in Lumbar Spine Bone Mineral Density (BMD)
|
5.68 Percentage change from baseline
Standard Deviation 3.535
|
5.19 Percentage change from baseline
Standard Deviation 4.118
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 26Population: The pharmacodynamic analysis set included all participants in the safety population with at least one evaluable pharmacodynamic parameter (%CfB and AUEC) and not had any protocol deviations that have a relevant impact on sCTX or serum Prokollagen Typ 1 N-terminales Propeptid (P1NP) results included in the pharmacodynamic parameter calculation. Here, 'number of participants analyzed' specifies all participants who were evaluated for this outcome measure.
The AUEC of %CfB in sCTX of RGB-14-P was assessed as part of pharmacodynamics parameter with US-licensed Prolia® in female participants was demonstrated with postmenopausal osteoporosis. This outcome measure was assessed for main period only.
Outcome measures
| Measure |
Main Period: RGB-14-P
n=208 Participants
Participants received RGB-14-P as subcutaneous (SC) injection on Day 1 of Treatment Period 1 (Week 0) and Treatment Period 2 (Week 26).
|
Main Period: Prolia®
n=196 Participants
Participants received Prolia® as SC injection on Day 1 of Treatment Period 1 (Week 0) and Treatment Period 2 (Week 26).
|
Transition Period: RGB-14-P to RGB-14-P
Participants who received RGB-14-P during the main period were re-randomized to receive RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52).
|
Transition Period: Prolia® to RGB-14-P
Participants who received Prolia® during the main period were re-randomized and received RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52).
|
Transition Period: Prolia® to Prolia®
Participants who received Prolia® during the main period were re-randomized and received Prolia® as SC injection on Day 1 of Treatment period 3 (Week 52).
|
|---|---|---|---|---|---|
|
Area Under the Effective Curve (AUEC) After the First Dose Until Day 183 of %CfB in Serum Type I Collagen C-telopeptide (sCTX)
|
14609.67 mg/dL*day
Standard Deviation 3142.086
|
14134.86 mg/dL*day
Standard Deviation 7331.714
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 26, 52 and 78Population: The FAS included all participants to whom the IMP has been randomized. Here, 'number of participants analyzed' specifies all participants who were evaluated for this outcome measure and 'number analyzed in each row' signifies participants with available data that were analyzed for specific timepoint.
%CfB in total hip BMD was assessed.
Outcome measures
| Measure |
Main Period: RGB-14-P
n=225 Participants
Participants received RGB-14-P as subcutaneous (SC) injection on Day 1 of Treatment Period 1 (Week 0) and Treatment Period 2 (Week 26).
|
Main Period: Prolia®
n=211 Participants
Participants received Prolia® as SC injection on Day 1 of Treatment Period 1 (Week 0) and Treatment Period 2 (Week 26).
|
Transition Period: RGB-14-P to RGB-14-P
n=63 Participants
Participants who received RGB-14-P during the main period were re-randomized to receive RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52).
|
Transition Period: Prolia® to RGB-14-P
n=62 Participants
Participants who received Prolia® during the main period were re-randomized and received RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52).
|
Transition Period: Prolia® to Prolia®
n=63 Participants
Participants who received Prolia® during the main period were re-randomized and received Prolia® as SC injection on Day 1 of Treatment period 3 (Week 52).
|
|---|---|---|---|---|---|
|
%CfB in Total Hip BMD
Week 26
|
2.42 Percentage change from baseline
Standard Deviation 2.659
|
2.69 Percentage change from baseline
Standard Deviation 2.519
|
2.46 Percentage change from baseline
Standard Deviation 2.712
|
2.81 Percentage change from baseline
Standard Deviation 2.607
|
3.35 Percentage change from baseline
Standard Deviation 2.559
|
|
%CfB in Total Hip BMD
Week 52
|
3.42 Percentage change from baseline
Standard Deviation 2.916
|
3.49 Percentage change from baseline
Standard Deviation 2.872
|
3.03 Percentage change from baseline
Standard Deviation 3.103
|
3.36 Percentage change from baseline
Standard Deviation 2.696
|
4.21 Percentage change from baseline
Standard Deviation 3.452
|
|
%CfB in Total Hip BMD
Week 78
|
—
|
—
|
4.24 Percentage change from baseline
Standard Deviation 3.381
|
4.12 Percentage change from baseline
Standard Deviation 3.128
|
4.95 Percentage change from baseline
Standard Deviation 3.849
|
SECONDARY outcome
Timeframe: Weeks 26 and 78Population: The FAS included all participants to whom the IMP has been randomized. Here, 'number of participants analyzed' specifies all participants who were evaluated for this outcome measure and 'number analyzed in each row' signifies participants with available data that were analyzed for specific timepoint.
%CfB in lumbar spine BMD was assessed.
Outcome measures
| Measure |
Main Period: RGB-14-P
n=227 Participants
Participants received RGB-14-P as subcutaneous (SC) injection on Day 1 of Treatment Period 1 (Week 0) and Treatment Period 2 (Week 26).
|
Main Period: Prolia®
n=218 Participants
Participants received Prolia® as SC injection on Day 1 of Treatment Period 1 (Week 0) and Treatment Period 2 (Week 26).
|
Transition Period: RGB-14-P to RGB-14-P
n=63 Participants
Participants who received RGB-14-P during the main period were re-randomized to receive RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52).
|
Transition Period: Prolia® to RGB-14-P
n=62 Participants
Participants who received Prolia® during the main period were re-randomized and received RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52).
|
Transition Period: Prolia® to Prolia®
n=63 Participants
Participants who received Prolia® during the main period were re-randomized and received Prolia® as SC injection on Day 1 of Treatment period 3 (Week 52).
|
|---|---|---|---|---|---|
|
%CfB in Lumbar Spine BMD
Week 26
|
3.56 Percentage change from baseline
Standard Deviation 3.747
|
3.45 Percentage change from baseline
Standard Deviation 4.227
|
3.98 Percentage change from baseline
Standard Deviation 3.185
|
3.39 Percentage change from baseline
Standard Deviation 3.848
|
3.68 Percentage change from baseline
Standard Deviation 4.979
|
|
%CfB in Lumbar Spine BMD
Week 78
|
—
|
—
|
7.03 Percentage change from baseline
Standard Deviation 3.828
|
7.06 Percentage change from baseline
Standard Deviation 4.327
|
7.09 Percentage change from baseline
Standard Deviation 4.240
|
SECONDARY outcome
Timeframe: Weeks 26, 52 and 78Population: The FAS included all participants to whom the IMP has been randomized. Here, 'number of participants analyzed' specifies all participants who were evaluated for this outcome measure and 'number analyzed in each row' signifies participants with available data that were analyzed for specific timepoint.
%CfB in femoral neck BMD was assessed by DXA.
Outcome measures
| Measure |
Main Period: RGB-14-P
n=225 Participants
Participants received RGB-14-P as subcutaneous (SC) injection on Day 1 of Treatment Period 1 (Week 0) and Treatment Period 2 (Week 26).
|
Main Period: Prolia®
n=211 Participants
Participants received Prolia® as SC injection on Day 1 of Treatment Period 1 (Week 0) and Treatment Period 2 (Week 26).
|
Transition Period: RGB-14-P to RGB-14-P
n=63 Participants
Participants who received RGB-14-P during the main period were re-randomized to receive RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52).
|
Transition Period: Prolia® to RGB-14-P
n=62 Participants
Participants who received Prolia® during the main period were re-randomized and received RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52).
|
Transition Period: Prolia® to Prolia®
n=63 Participants
Participants who received Prolia® during the main period were re-randomized and received Prolia® as SC injection on Day 1 of Treatment period 3 (Week 52).
|
|---|---|---|---|---|---|
|
%CfB in Femoral Neck BMD
Week 26
|
1.88 Percentage change from baseline
Standard Deviation 3.040
|
1.94 Percentage change from baseline
Standard Deviation 3.610
|
1.60 Percentage change from baseline
Standard Deviation 2.833
|
2.21 Percentage change from baseline
Standard Deviation 3.296
|
2.35 Percentage change from baseline
Standard Deviation 4.057
|
|
%CfB in Femoral Neck BMD
Week 52
|
2.42 Percentage change from baseline
Standard Deviation 3.687
|
2.64 Percentage change from baseline
Standard Deviation 3.751
|
1.95 Percentage change from baseline
Standard Deviation 3.621
|
2.60 Percentage change from baseline
Standard Deviation 3.127
|
3.24 Percentage change from baseline
Standard Deviation 4.549
|
|
%CfB in Femoral Neck BMD
Week 78
|
—
|
—
|
3.08 Percentage change from baseline
Standard Deviation 4.259
|
3.06 Percentage change from baseline
Standard Deviation 3.337
|
4.04 Percentage change from baseline
Standard Deviation 4.764
|
SECONDARY outcome
Timeframe: Weeks 52 and 78Population: The FAS included all participants to whom the IMP has been randomized. Here, 'number analyzed in each row' signifies the participants with available data that were analyzed for specific timepoint for that outcome measure.
Number of participants with vertebral fragility fracture was assessed. Information on vertebral fractures was centrally collected through the evaluation of lateral thoraco-lumbar spine X-ray.
Outcome measures
| Measure |
Main Period: RGB-14-P
n=242 Participants
Participants received RGB-14-P as subcutaneous (SC) injection on Day 1 of Treatment Period 1 (Week 0) and Treatment Period 2 (Week 26).
|
Main Period: Prolia®
n=231 Participants
Participants received Prolia® as SC injection on Day 1 of Treatment Period 1 (Week 0) and Treatment Period 2 (Week 26).
|
Transition Period: RGB-14-P to RGB-14-P
n=63 Participants
Participants who received RGB-14-P during the main period were re-randomized to receive RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52).
|
Transition Period: Prolia® to RGB-14-P
n=62 Participants
Participants who received Prolia® during the main period were re-randomized and received RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52).
|
Transition Period: Prolia® to Prolia®
n=63 Participants
Participants who received Prolia® during the main period were re-randomized and received Prolia® as SC injection on Day 1 of Treatment period 3 (Week 52).
|
|---|---|---|---|---|---|
|
Number of Participants With Vertebral Fragility Fracture
Week 52
|
4 Participants
|
8 Participants
|
—
|
—
|
—
|
|
Number of Participants With Vertebral Fragility Fracture
Week 78
|
—
|
—
|
3 Participants
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Weeks 52 and 78Population: The FAS included all participants to whom the IMP has been randomized. Here, 'number analyzed in each row' signifies the participants with available data that were analyzed for specific timepoint for that outcome measure.
Number of participants with non-vertebral fragility fracture was assessed. Information on non-vertebral fractures was centrally collected through the evaluation of lateral thoraco-lumbar spine X-ray.
Outcome measures
| Measure |
Main Period: RGB-14-P
n=242 Participants
Participants received RGB-14-P as subcutaneous (SC) injection on Day 1 of Treatment Period 1 (Week 0) and Treatment Period 2 (Week 26).
|
Main Period: Prolia®
n=231 Participants
Participants received Prolia® as SC injection on Day 1 of Treatment Period 1 (Week 0) and Treatment Period 2 (Week 26).
|
Transition Period: RGB-14-P to RGB-14-P
n=63 Participants
Participants who received RGB-14-P during the main period were re-randomized to receive RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52).
|
Transition Period: Prolia® to RGB-14-P
n=62 Participants
Participants who received Prolia® during the main period were re-randomized and received RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52).
|
Transition Period: Prolia® to Prolia®
n=63 Participants
Participants who received Prolia® during the main period were re-randomized and received Prolia® as SC injection on Day 1 of Treatment period 3 (Week 52).
|
|---|---|---|---|---|---|
|
Number of Participants With Non-vertebral Fragility Fracture
Week 52
|
4 Participants
|
10 Participants
|
—
|
—
|
—
|
|
Number of Participants With Non-vertebral Fragility Fracture
Week 78
|
—
|
—
|
2 Participants
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Weeks 4, 26, 52 and 78Population: PD analysis set included all participants in safety population with at least one evaluable PD parameter (%CfB and AUEC) and not had any protocol deviations that have a relevant impact on sCTX or serum P1NP results included in PD parameter calculation. Here, 'number of participants analyzed' specifies all participants who were evaluated for this outcome measure and 'number analyzed in each row' signifies participants with available data that were analyzed for specific timepoint.
%CfB in serum P1NP was assessed as part of pharmacodynamics parameter with US-licensed Prolia® in female participants with postmenopausal osteoporosis.
Outcome measures
| Measure |
Main Period: RGB-14-P
n=234 Participants
Participants received RGB-14-P as subcutaneous (SC) injection on Day 1 of Treatment Period 1 (Week 0) and Treatment Period 2 (Week 26).
|
Main Period: Prolia®
n=220 Participants
Participants received Prolia® as SC injection on Day 1 of Treatment Period 1 (Week 0) and Treatment Period 2 (Week 26).
|
Transition Period: RGB-14-P to RGB-14-P
n=60 Participants
Participants who received RGB-14-P during the main period were re-randomized to receive RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52).
|
Transition Period: Prolia® to RGB-14-P
n=60 Participants
Participants who received Prolia® during the main period were re-randomized and received RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52).
|
Transition Period: Prolia® to Prolia®
n=62 Participants
Participants who received Prolia® during the main period were re-randomized and received Prolia® as SC injection on Day 1 of Treatment period 3 (Week 52).
|
|---|---|---|---|---|---|
|
%CfB in Serum Procollagen Type 1 N Terminal Propeptide (P1NP)
Week 4
|
22.10 Percentage change from baseline
Standard Deviation 14.905
|
20.22 Percentage change from baseline
Standard Deviation 15.091
|
19.85 Percentage change from baseline
Standard Deviation 13.939
|
18.45 Percentage change from baseline
Standard Deviation 15.835
|
17.31 Percentage change from baseline
Standard Deviation 15.524
|
|
%CfB in Serum Procollagen Type 1 N Terminal Propeptide (P1NP)
Week 26
|
65.92 Percentage change from baseline
Standard Deviation 17.828
|
62.89 Percentage change from baseline
Standard Deviation 29.294
|
68.42 Percentage change from baseline
Standard Deviation 11.693
|
63.41 Percentage change from baseline
Standard Deviation 42.677
|
66.08 Percentage change from baseline
Standard Deviation 16.098
|
|
%CfB in Serum Procollagen Type 1 N Terminal Propeptide (P1NP)
Week 52
|
65.04 Percentage change from baseline
Standard Deviation 19.131
|
63.82 Percentage change from baseline
Standard Deviation 21.712
|
64.86 Percentage change from baseline
Standard Deviation 16.902
|
66.05 Percentage change from baseline
Standard Deviation 20.428
|
65.89 Percentage change from baseline
Standard Deviation 17.651
|
|
%CfB in Serum Procollagen Type 1 N Terminal Propeptide (P1NP)
Week 78
|
—
|
—
|
64.12 Percentage change from baseline
Standard Deviation 18.845
|
66.91 Percentage change from baseline
Standard Deviation 16.816
|
63.08 Percentage change from baseline
Standard Deviation 21.364
|
SECONDARY outcome
Timeframe: Weeks 4, 26, 52 and 78Population: PD analysis set included all participants in safety population with at least one evaluable PD parameter (%CfB and AUEC) and not had any protocol deviations that have a relevant impact on sCTX or serum P1NP results included in PD parameter calculation. Here, 'number of participants analyzed' specifies all participants who were evaluated for this outcome measure and 'number analyzed in each row' signifies participants with available data that were analyzed for specific timepoint.
%CfB in sCTX was assessed as part of pharmacodynamics parameter with US-licensed Prolia® was assessed in female participants with postmenopausal osteoporosis.
Outcome measures
| Measure |
Main Period: RGB-14-P
n=234 Participants
Participants received RGB-14-P as subcutaneous (SC) injection on Day 1 of Treatment Period 1 (Week 0) and Treatment Period 2 (Week 26).
|
Main Period: Prolia®
n=220 Participants
Participants received Prolia® as SC injection on Day 1 of Treatment Period 1 (Week 0) and Treatment Period 2 (Week 26).
|
Transition Period: RGB-14-P to RGB-14-P
n=60 Participants
Participants who received RGB-14-P during the main period were re-randomized to receive RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52).
|
Transition Period: Prolia® to RGB-14-P
n=60 Participants
Participants who received Prolia® during the main period were re-randomized and received RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52).
|
Transition Period: Prolia® to Prolia®
n=62 Participants
Participants who received Prolia® during the main period were re-randomized and received Prolia® as SC injection on Day 1 of Treatment period 3 (Week 52).
|
|---|---|---|---|---|---|
|
%CfB in Serum Type I Collagen C-telopeptide (sCTX)
Week 4
|
85.87 Percentage change from baseline
Standard Deviation 9.567
|
85.38 Percentage change from baseline
Standard Deviation 15.501
|
84.96 Percentage change from baseline
Standard Deviation 11.206
|
84.71 Percentage change from baseline
Standard Deviation 23.071
|
88.08 Percentage change from baseline
Standard Deviation 5.832
|
|
%CfB in Serum Type I Collagen C-telopeptide (sCTX)
Week 26
|
69.74 Percentage change from baseline
Standard Deviation 23.212
|
61.51 Percentage change from baseline
Standard Deviation 83.764
|
67.29 Percentage change from baseline
Standard Deviation 23.572
|
53.23 Percentage change from baseline
Standard Deviation 147.679
|
71.27 Percentage change from baseline
Standard Deviation 17.483
|
|
%CfB in Serum Type I Collagen C-telopeptide (sCTX)
Week 52
|
62.90 Percentage change from baseline
Standard Deviation 28.995
|
58.26 Percentage change from baseline
Standard Deviation 63.927
|
60.41 Percentage change from baseline
Standard Deviation 31.958
|
53.89 Percentage change from baseline
Standard Deviation 94.853
|
66.79 Percentage change from baseline
Standard Deviation 24.151
|
|
%CfB in Serum Type I Collagen C-telopeptide (sCTX)
Week 78
|
—
|
—
|
58.70 Percentage change from baseline
Standard Deviation 34.117
|
53.32 Percentage change from baseline
Standard Deviation 42.855
|
57.38 Percentage change from baseline
Standard Deviation 30.562
|
SECONDARY outcome
Timeframe: Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78Population: Safety analysis set included all participants who received at least one full or partial dose of IMP.
The safety and tolerability of RGB-14-P with US-licensed Prolia® in female participants with postmenopausal osteoporosis was assessed.
Outcome measures
| Measure |
Main Period: RGB-14-P
n=242 Participants
Participants received RGB-14-P as subcutaneous (SC) injection on Day 1 of Treatment Period 1 (Week 0) and Treatment Period 2 (Week 26).
|
Main Period: Prolia®
n=231 Participants
Participants received Prolia® as SC injection on Day 1 of Treatment Period 1 (Week 0) and Treatment Period 2 (Week 26).
|
Transition Period: RGB-14-P to RGB-14-P
n=63 Participants
Participants who received RGB-14-P during the main period were re-randomized to receive RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52).
|
Transition Period: Prolia® to RGB-14-P
n=62 Participants
Participants who received Prolia® during the main period were re-randomized and received RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52).
|
Transition Period: Prolia® to Prolia®
n=63 Participants
Participants who received Prolia® during the main period were re-randomized and received Prolia® as SC injection on Day 1 of Treatment period 3 (Week 52).
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any treatment related TEAE
|
36 Participants
|
32 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Deaths
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any AE leading to death
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any TEAE leading to death
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any injection site reactions severe or worse severity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any AE
|
161 Participants
|
158 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any TEAEs
|
158 Participants
|
152 Participants
|
30 Participants
|
25 Participants
|
25 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any TEAEs severe or worse severity
|
8 Participants
|
9 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any treatment related TEAE severe or worse severity
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any serious TEAEs
|
7 Participants
|
16 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any serious TEAEs severe or worse severity
|
5 Participants
|
9 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any non-serious TEAEs
|
158 Participants
|
149 Participants
|
30 Participants
|
25 Participants
|
25 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any AEs leading to participant discontinuation
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any TEAEs leading to subject discontinuation
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any treatment related TEAE leading to participant discontinuation
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any TEAEs leading to discontinuation of IMP
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any treatment related TEAE leading to discontinuation of IMP
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any fracture TEAE
|
9 Participants
|
18 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any fracture TEAE severe or worse severity
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any serious fracture TEAEs
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any serious fracture TEAEs severe or worse severity
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any injection site reactions
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any treatment related serious TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any treatment related serious TEAE severe or worse severity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any treatment related fracture TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any treatment related fracture TEAE severe or worse severity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any treatment related serious fracture TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any treatment related serious fracture TEAE severe or worse severity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any treatment related fatal serious TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any injection site reactions of CTCAE grade ≥ 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Weeks 0, 2, 4, 26, 28, 30, 52, 54, 56 and 78Population: Immunogenicity analysis set included all participants in the safety population who had the pre-dose immunogenicity result and at least one available post-baseline immunogenicity assessment. Here, 'number analyzed in each row' signifies the participants with available data that were analyzed for specific timepoint for that outcome measure.
Number of participants with positive ADAs was assessed.
Outcome measures
| Measure |
Main Period: RGB-14-P
n=239 Participants
Participants received RGB-14-P as subcutaneous (SC) injection on Day 1 of Treatment Period 1 (Week 0) and Treatment Period 2 (Week 26).
|
Main Period: Prolia®
n=228 Participants
Participants received Prolia® as SC injection on Day 1 of Treatment Period 1 (Week 0) and Treatment Period 2 (Week 26).
|
Transition Period: RGB-14-P to RGB-14-P
n=63 Participants
Participants who received RGB-14-P during the main period were re-randomized to receive RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52).
|
Transition Period: Prolia® to RGB-14-P
n=62 Participants
Participants who received Prolia® during the main period were re-randomized and received RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52).
|
Transition Period: Prolia® to Prolia®
n=62 Participants
Participants who received Prolia® during the main period were re-randomized and received Prolia® as SC injection on Day 1 of Treatment period 3 (Week 52).
|
|---|---|---|---|---|---|
|
Number of Participants With Anti-drug Antibodies (ADAs)
Week 0
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs)
Week 2
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs)
Week 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs)
Week 26
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs)
Week 28
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs)
Week 30
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs)
Week 52
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs)
Week 54
|
—
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs)
Week 56
|
—
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs)
Week 78
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Weeks 0, 2, 4, 26, 28, 30, 52, 54, 56 and 78Population: Immunogenicity analysis set included all participants in the safety population who had the pre-dose immunogenicity result and at least one available post-baseline immunogenicity assessment. Here, 'number analyzed in each row' signifies the participants with available data that were analyzed for specific timepoint for that outcome measure.
Number of participants with positive neutralizing antibodies was assessed.
Outcome measures
| Measure |
Main Period: RGB-14-P
n=2 Participants
Participants received RGB-14-P as subcutaneous (SC) injection on Day 1 of Treatment Period 1 (Week 0) and Treatment Period 2 (Week 26).
|
Main Period: Prolia®
n=2 Participants
Participants received Prolia® as SC injection on Day 1 of Treatment Period 1 (Week 0) and Treatment Period 2 (Week 26).
|
Transition Period: RGB-14-P to RGB-14-P
Participants who received RGB-14-P during the main period were re-randomized to receive RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52).
|
Transition Period: Prolia® to RGB-14-P
Participants who received Prolia® during the main period were re-randomized and received RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52).
|
Transition Period: Prolia® to Prolia®
n=1 Participants
Participants who received Prolia® during the main period were re-randomized and received Prolia® as SC injection on Day 1 of Treatment period 3 (Week 52).
|
|---|---|---|---|---|---|
|
Number of Participants With Neutralizing Antibodies
Week 0
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Neutralizing Antibodies
Week 2
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Neutralizing Antibodies
Week 28
|
—
|
1 Participants
|
—
|
—
|
1 Participants
|
|
Number of Participants With Neutralizing Antibodies
Week 30
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Neutralizing Antibodies
Week 54
|
—
|
—
|
—
|
—
|
1 Participants
|
|
Number of Participants With Neutralizing Antibodies
Week 56
|
—
|
—
|
—
|
—
|
1 Participants
|
SECONDARY outcome
Timeframe: Weeks 0, 2, 4, 26, 28, 30, 52, 54, 56 and 78Population: Immunogenicity analysis set included all participants in the safety population who had the pre-dose immunogenicity result and at least one available post-baseline immunogenicity assessment. Here, 'number analyzed in each row' signifies the participants with available data that were analyzed for specific timepoint for that outcome measure.
The immunogenicity of RGB -14- P with US-licensed Prolia® in female participants with postmenopausal osteoporosis was assessed.
Outcome measures
| Measure |
Main Period: RGB-14-P
n=239 Participants
Participants received RGB-14-P as subcutaneous (SC) injection on Day 1 of Treatment Period 1 (Week 0) and Treatment Period 2 (Week 26).
|
Main Period: Prolia®
n=228 Participants
Participants received Prolia® as SC injection on Day 1 of Treatment Period 1 (Week 0) and Treatment Period 2 (Week 26).
|
Transition Period: RGB-14-P to RGB-14-P
n=63 Participants
Participants who received RGB-14-P during the main period were re-randomized to receive RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52).
|
Transition Period: Prolia® to RGB-14-P
n=62 Participants
Participants who received Prolia® during the main period were re-randomized and received RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52).
|
Transition Period: Prolia® to Prolia®
n=62 Participants
Participants who received Prolia® during the main period were re-randomized and received Prolia® as SC injection on Day 1 of Treatment period 3 (Week 52).
|
|---|---|---|---|---|---|
|
Titre of ADAs
Week 28
|
NA Titre
Here, "NA" indicates that titre was not evaluable due to no positive ADA response.
|
172.0 Titre
Interval 172.0 to 172.0
|
NA Titre
Here, "NA" indicates that titre was not evaluable due to no positive ADA response.
|
NA Titre
Here, "NA" indicates that titre was not evaluable due to no positive ADA response.
|
172.0 Titre
Interval 172.0 to 172.0
|
|
Titre of ADAs
Week 0
|
NA Titre
Here, "NA" indicates that titre was not evaluable due to no positive ADA response.
|
302.0 Titre
Interval 302.0 to 302.0
|
NA Titre
Here, "NA" indicates that titre was not evaluable due to no positive ADA response.
|
NA Titre
Here, "NA" indicates that titre was not evaluable due to no positive ADA response.
|
NA Titre
Here, "NA" indicates that titre was not evaluable due to no positive ADA response.
|
|
Titre of ADAs
Week 2
|
761.0 Titre
Interval 60.0 to 1462.0
|
NA Titre
Here, "NA" indicates that titre was not evaluable due to no positive ADA response.
|
NA Titre
Here, "NA" indicates that titre was not evaluable due to no positive ADA response.
|
NA Titre
Here, "NA" indicates that titre was not evaluable due to no positive ADA response.
|
NA Titre
Here, "NA" indicates that titre was not evaluable due to no positive ADA response.
|
|
Titre of ADAs
Week 4
|
NA Titre
Here, "NA" indicates that titre was not evaluable due to no positive ADA response.
|
NA Titre
Here, "NA" indicates that titre was not evaluable due to no positive ADA response.
|
NA Titre
Here, "NA" indicates that titre was not evaluable due to no positive ADA response.
|
NA Titre
Here, "NA" indicates that titre was not evaluable due to no positive ADA response.
|
NA Titre
Here, "NA" indicates that titre was not evaluable due to no positive ADA response.
|
|
Titre of ADAs
Week 26
|
NA Titre
Here, "NA" indicates that titre was not evaluable due to no positive ADA response.
|
NA Titre
Here, "NA" indicates that titre was not evaluable due to no positive ADA response.
|
NA Titre
Here, "NA" indicates that titre was not evaluable due to no positive ADA response.
|
NA Titre
Here, "NA" indicates that titre was not evaluable due to no positive ADA response.
|
NA Titre
Here, "NA" indicates that titre was not evaluable due to no positive ADA response.
|
|
Titre of ADAs
Week 30
|
NA Titre
Here, "NA" indicates that titre was not evaluable due to no positive ADA response.
|
211.0 Titre
Interval 211.0 to 211.0
|
NA Titre
Here, "NA" indicates that titre was not evaluable due to no positive ADA response.
|
NA Titre
Here, "NA" indicates that titre was not evaluable due to no positive ADA response.
|
211.0 Titre
Interval 211.0 to 211.0
|
|
Titre of ADAs
Week 52
|
NA Titre
Here, "NA" indicates that titre was not evaluable due to no positive ADA response.
|
NA Titre
Here, "NA" indicates that titre was not evaluable due to no positive ADA response.
|
NA Titre
Here, "NA" indicates that titre was not evaluable due to no positive ADA response.
|
NA Titre
Here, "NA" indicates that titre was not evaluable due to no positive ADA response.
|
NA Titre
Here, "NA" indicates that titre was not evaluable due to no positive ADA response.
|
|
Titre of ADAs
Week 54
|
—
|
—
|
NA Titre
Here, "NA" indicates that titre was not evaluable due to no positive ADA response.
|
NA Titre
Here, "NA" indicates that titre was not evaluable due to no positive ADA response.
|
224.0 Titre
Interval 224.0 to 224.0
|
|
Titre of ADAs
Week 56
|
—
|
—
|
NA Titre
Here, "NA" indicates that titre was not evaluable due to no positive ADA response.
|
NA Titre
Here, "NA" indicates that titre was not evaluable due to no positive ADA response.
|
152.0 Titre
Interval 152.0 to 152.0
|
|
Titre of ADAs
Week 78
|
—
|
—
|
NA Titre
Here, "NA" indicates that titre was not evaluable due to no positive ADA response.
|
NA Titre
Here, "NA" indicates that titre was not evaluable due to no positive ADA response.
|
NA Titre
Here, "NA" indicates that titre was not evaluable due to no positive ADA response.
|
Adverse Events
Main Period: RGB-14-P
Serious events: 7 serious events
Other events: 100 other events
Deaths: 0 deaths
Main Period: Prolia®
Serious events: 16 serious events
Other events: 85 other events
Deaths: 1 deaths
Transition Period: RGB-14-P to RGB-14-P
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Transition Period: Prolia® to RGB-14-P
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Transition Period: Prolia® to Prolia®
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Main Period: RGB-14-P
n=242 participants at risk
Participants received RGB-14-P as subcutaneous (SC) injection on Day 1 of Treatment Period 1 (Week 0) and Treatment Period 2 (Week 26).
|
Main Period: Prolia®
n=231 participants at risk
Participants received Prolia® as SC injection on Day 1 of Treatment Period 1 (Week 0) and Treatment Period 2 (Week 26).
|
Transition Period: RGB-14-P to RGB-14-P
n=63 participants at risk
Participants who received RGB-14-P during the main period were re-randomized to receive RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52).
|
Transition Period: Prolia® to RGB-14-P
n=62 participants at risk
Participants who received Prolia® during the main period were re-randomized and received RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52).
|
Transition Period: Prolia® to Prolia®
n=63 participants at risk
Participants who received Prolia® during the main period were re-randomized and received Prolia® as SC injection on Day 1 of Treatment period 3 (Week 52).
|
|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicular lymphoma
|
0.00%
0/242 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.43%
1/231 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/62 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/242 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.43%
1/231 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/62 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/242 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.43%
1/231 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/62 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.41%
1/242 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/231 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/62 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.41%
1/242 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.43%
1/231 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/62 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/242 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.43%
1/231 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/62 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/242 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.43%
1/231 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/62 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
|
Infections and infestations
Pneumonia
|
0.41%
1/242 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/231 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/62 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.41%
1/242 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/231 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/62 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/242 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.43%
1/231 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/62 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/242 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.43%
1/231 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/62 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.41%
1/242 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/231 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/62 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/242 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.43%
1/231 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/62 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/242 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.43%
1/231 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/62 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.00%
0/242 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.43%
1/231 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/62 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
|
Nervous system disorders
Lumbosacral radiculopathy
|
0.41%
1/242 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/231 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/62 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
|
Psychiatric disorders
Anxiety disorder
|
0.41%
1/242 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/231 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/62 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
|
Psychiatric disorders
Panic attack
|
0.41%
1/242 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/231 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/62 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.41%
1/242 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.43%
1/231 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/62 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/242 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.43%
1/231 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/62 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/242 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.43%
1/231 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/62 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/242 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.43%
1/231 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/62 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/242 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.43%
1/231 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/62 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/242 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.43%
1/231 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/62 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/242 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.43%
1/231 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/62 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/242 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.43%
1/231 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/62 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/242 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.43%
1/231 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/62 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
|
Reproductive system and breast disorders
Endometrial disorder
|
0.00%
0/242 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.43%
1/231 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/62 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
Other adverse events
| Measure |
Main Period: RGB-14-P
n=242 participants at risk
Participants received RGB-14-P as subcutaneous (SC) injection on Day 1 of Treatment Period 1 (Week 0) and Treatment Period 2 (Week 26).
|
Main Period: Prolia®
n=231 participants at risk
Participants received Prolia® as SC injection on Day 1 of Treatment Period 1 (Week 0) and Treatment Period 2 (Week 26).
|
Transition Period: RGB-14-P to RGB-14-P
n=63 participants at risk
Participants who received RGB-14-P during the main period were re-randomized to receive RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52).
|
Transition Period: Prolia® to RGB-14-P
n=62 participants at risk
Participants who received Prolia® during the main period were re-randomized and received RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52).
|
Transition Period: Prolia® to Prolia®
n=63 participants at risk
Participants who received Prolia® during the main period were re-randomized and received Prolia® as SC injection on Day 1 of Treatment period 3 (Week 52).
|
|---|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
10.3%
25/242 • Number of events 25 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
10.4%
24/231 • Number of events 25 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/62 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
|
Infections and infestations
Nasopharyngitis
|
9.5%
23/242 • Number of events 29 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
9.1%
21/231 • Number of events 28 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
1.6%
1/63 • Number of events 1 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
3.2%
2/62 • Number of events 2 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
6.3%
4/63 • Number of events 4 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.5%
23/242 • Number of events 34 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
4.8%
11/231 • Number of events 13 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/62 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
|
Infections and infestations
Urinary tract infection
|
4.5%
11/242 • Number of events 13 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
4.8%
11/231 • Number of events 17 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/62 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
9.1%
22/242 • Number of events 31 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
9.5%
22/231 • Number of events 27 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
4.8%
3/63 • Number of events 3 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
1.6%
1/62 • Number of events 1 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
3.2%
2/63 • Number of events 2 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
12/242 • Number of events 16 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
4.3%
10/231 • Number of events 13 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/62 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
|
Vascular disorders
Hypertension
|
3.3%
8/242 • Number of events 9 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
5.6%
13/231 • Number of events 14 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/62 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
|
Nervous system disorders
Headache
|
5.8%
14/242 • Number of events 15 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
1.7%
4/231 • Number of events 5 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/62 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
0.00%
0/63 • Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
|
Additional Information
Medical Information Scientific Service
Gedeon Richter Plc.
Phone: +36 1 505 70 32
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee No unpublished information may be disclosed without prior written approval from sponsor.
- Publication restrictions are in place
Restriction type: OTHER