Trial Outcomes & Findings for Denosumab, Teriparatide or Both for the Treatment of Postmenopausal Osteoporosis (NCT NCT00926380)
NCT ID: NCT00926380
Last Updated: 2018-06-29
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
94 participants
Primary outcome timeframe
Baseline and 2 years
Results posted on
2018-06-29
Participant Flow
Participant milestones
| Measure |
Denosumab ONLY
denosumab: denosumab: 60 mg SC every 6 months
|
Teriparatide (Forteo®) ONLY
teriparatide: teriparatide: 20 mcg SC QD
|
Denosumab and Teriparatide (Forteo®)
denosumab: denosumab: 60 mg SC every 6 months
teriparatide: teriparatide: 20 mcg SC QD
|
|---|---|---|---|
|
Year 1
STARTED
|
33
|
31
|
30
|
|
Year 1
COMPLETED
|
33
|
30
|
29
|
|
Year 1
NOT COMPLETED
|
0
|
1
|
1
|
|
Year 2
STARTED
|
33
|
30
|
29
|
|
Year 2
COMPLETED
|
31
|
28
|
24
|
|
Year 2
NOT COMPLETED
|
2
|
2
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Denosumab, Teriparatide or Both for the Treatment of Postmenopausal Osteoporosis
Baseline characteristics by cohort
| Measure |
Denosumab ONLY
n=33 Participants
denosumab: denosumab: 60 mg SC every 6 months
|
Teriparatide (Forteo®) ONLY
n=31 Participants
teriparatide: teriparatide: 20 mcg SC QD
|
Denosumab and Teriparatide (Forteo®)
n=30 Participants
denosumab: denosumab: 60 mg SC every 6 months
teriparatide: teriparatide: 20 mcg SC QD
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66.3 years
STANDARD_DEVIATION 8.3 • n=99 Participants
|
65.5 years
STANDARD_DEVIATION 7.9 • n=107 Participants
|
65.9 years
STANDARD_DEVIATION 9.0 • n=206 Participants
|
65.9 years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
94 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
92 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
90 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
33 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
94 Participants
n=7 Participants
|
|
Body-mass index
|
24.1 kg/m^2
STANDARD_DEVIATION 3.9 • n=99 Participants
|
25.5 kg/m^2
STANDARD_DEVIATION 3.8 • n=107 Participants
|
25.4 kg/m^2
STANDARD_DEVIATION 4.9 • n=206 Participants
|
25.0 kg/m^2
STANDARD_DEVIATION 4.2 • n=7 Participants
|
|
History of fragility fracture
|
12 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
38 Participants
n=7 Participants
|
|
Previous oral bisphosphonate use
|
12 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
35 Participants
n=7 Participants
|
|
25-Hydroxyvitamin D (ng/mL)
|
35.3 ng/mL
STANDARD_DEVIATION 10.5 • n=99 Participants
|
31.2 ng/mL
STANDARD_DEVIATION 8.5 • n=107 Participants
|
33.9 ng/mL
STANDARD_DEVIATION 11.8 • n=206 Participants
|
33.5 ng/mL
STANDARD_DEVIATION 10.5 • n=7 Participants
|
|
Alkaline phosphatase concentration in serum (U/L)
|
78.8 U/L
STANDARD_DEVIATION 16.8 • n=99 Participants
|
75.8 U/L
STANDARD_DEVIATION 16.8 • n=107 Participants
|
84.2 U/L
STANDARD_DEVIATION 20.8 • n=206 Participants
|
79.6 U/L
STANDARD_DEVIATION 18.4 • n=7 Participants
|
|
Osteocalcin (ng/mL)
|
42.9 ng/mL
STANDARD_DEVIATION 19.4 • n=99 Participants
|
49.0 ng/mL
STANDARD_DEVIATION 28.8 • n=107 Participants
|
52.2 ng/mL
STANDARD_DEVIATION 29.9 • n=206 Participants
|
47.8 ng/mL
STANDARD_DEVIATION 26.2 • n=7 Participants
|
|
Serum amino-terminal propeptide of type 1 procollagen (P1NP) (µg/L)
|
45.7 µg/L
STANDARD_DEVIATION 16.7 • n=99 Participants
|
46.0 µg/L
STANDARD_DEVIATION 19.5 • n=107 Participants
|
49.3 µg/L
STANDARD_DEVIATION 20.9 • n=206 Participants
|
47.1 µg/L
STANDARD_DEVIATION 19.0 • n=7 Participants
|
|
Serum β-C-terminal telopeptide of type 1 collagen (CTX) (ng/mL)
|
0.39 ng/mL
STANDARD_DEVIATION 0.21 • n=99 Participants
|
0.36 ng/mL
STANDARD_DEVIATION 0.15 • n=107 Participants
|
0.43 ng/mL
STANDARD_DEVIATION 0.17 • n=206 Participants
|
0.39 ng/mL
STANDARD_DEVIATION 0.18 • n=7 Participants
|
|
DXA Bone Density (g/cm^2) (Posterior-anterior lumbar spine)
|
0.866 g/cm^2
STANDARD_DEVIATION 0.088 • n=99 Participants
|
0.823 g/cm^2
STANDARD_DEVIATION 0.111 • n=107 Participants
|
0.856 g/cm^2
STANDARD_DEVIATION 0.131 • n=206 Participants
|
0.848 g/cm^2
STANDARD_DEVIATION 0.112 • n=7 Participants
|
|
DXA Bone Density (g/cm^2) (Femoral neck)
|
0.641 g/cm^2
STANDARD_DEVIATION 0.086 • n=99 Participants
|
0.643 g/cm^2
STANDARD_DEVIATION 0.061 • n=107 Participants
|
0.642 g/cm^2
STANDARD_DEVIATION 0.067 • n=206 Participants
|
0.642 g/cm^2
STANDARD_DEVIATION 0.071 • n=7 Participants
|
|
DXA Bone Density (g/cm^2) (Total hip)
|
0.766 g/cm^2
STANDARD_DEVIATION 0.100 • n=99 Participants
|
0.757 g/cm^2
STANDARD_DEVIATION 0.068 • n=107 Participants
|
0.759 g/cm^2
STANDARD_DEVIATION 0.073 • n=206 Participants
|
0.761 g/cm^2
STANDARD_DEVIATION 0.081 • n=7 Participants
|
|
DXA Bone Density (g/cm^2) (Distal 1/3 of the radius shaft)
|
0.602 g/cm^2
STANDARD_DEVIATION 0.082 • n=99 Participants
|
0.612 g/cm^2
STANDARD_DEVIATION 0.069 • n=107 Participants
|
0.613 g/cm^2
STANDARD_DEVIATION 0.070 • n=206 Participants
|
0.609 g/cm^2
STANDARD_DEVIATION 0.073 • n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline and 2 yearsOutcome measures
| Measure |
Denosumab ONLY
n=33 Participants
denosumab: denosumab: 60 mg SC every 6 months
|
Teriparatide (Forteo®) ONLY
n=31 Participants
teriparatide: teriparatide: 20 mcg SC QD
|
Denosumab and Teriparatide (Forteo®)
n=30 Participants
denosumab: denosumab: 60 mg SC every 6 months
teriparatide: teriparatide: 20 mcg SC QD
|
|---|---|---|---|
|
Change in Spine Bone Density From Baseline to 2 Years
|
8.3 percent change
Standard Error 3.4
|
9.5 percent change
Standard Error 5.9
|
12.9 percent change
Standard Error 5.0
|
Adverse Events
Denosumab ONLY
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Teriparatide (Forteo®) ONLY
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Denosumab and Teriparatide (Forteo®)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Denosumab ONLY
n=33 participants at risk
denosumab: denosumab: 60 mg SC every 6 months
|
Teriparatide (Forteo®) ONLY
n=31 participants at risk
teriparatide: teriparatide: 20 mcg SC QD
|
Denosumab and Teriparatide (Forteo®)
n=30 participants at risk
denosumab: denosumab: 60 mg SC every 6 months
teriparatide: teriparatide: 20 mcg SC QD
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
3.0%
1/33
|
3.2%
1/31
|
0.00%
0/30
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanoma
|
0.00%
0/33
|
0.00%
0/31
|
3.3%
1/30
|
|
Cardiac disorders
Heart attack
|
0.00%
0/33
|
3.2%
1/31
|
0.00%
0/30
|
Other adverse events
| Measure |
Denosumab ONLY
n=33 participants at risk
denosumab: denosumab: 60 mg SC every 6 months
|
Teriparatide (Forteo®) ONLY
n=31 participants at risk
teriparatide: teriparatide: 20 mcg SC QD
|
Denosumab and Teriparatide (Forteo®)
n=30 participants at risk
denosumab: denosumab: 60 mg SC every 6 months
teriparatide: teriparatide: 20 mcg SC QD
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
12.1%
4/33
|
0.00%
0/31
|
6.7%
2/30
|
|
Skin and subcutaneous tissue disorders
Reactions at injection site
|
0.00%
0/33
|
6.5%
2/31
|
0.00%
0/30
|
|
Endocrine disorders
Hypercalcemia
|
0.00%
0/33
|
0.00%
0/31
|
6.7%
2/30
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/33
|
9.7%
3/31
|
0.00%
0/30
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place