Trial Outcomes & Findings for Novel Combination Therapy for Osteoporosis in Men (NCT NCT03994172)
NCT ID: NCT03994172
Last Updated: 2026-09-03
Results Overview
Hypothesis 1a proposes that BMD responses to combined TPTD+cinacalcet are greater than those induced by TPTD+PBO. LS BMD typically responds quickly and robustly to TPTD and is the 1o endpoint of the trial. DXA measurements will be performed and analyzed by standard protocols at baseline and at the end of the trial. Subjects will be treated for 11 months (48 weeks). All subjects will receive Ca and vitamin D3 supplements throughout the trial. The percentage change in LS BMD from baseline to 48 week/11 months of treatment will be the variable/endpoint that is calculated.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
48 weeks
Results posted on
2026-09-03
Participant Flow
Subjects were recruited from the San Francisco Veterans Affairs (SFVA) clinics through direct referrals by their providers, through advertisements at the medical center and in clinics, and by our review with the permission of the Institutional Review Board (IRB) the results of dual energy xray absorptiometry (DXA) testing that was done at the SFVA. We had permission from the IRB to send a letter allowing eligible patients who had DXA screening to consider participating in the study.
After undergoing informed consent discussion and signing the trial related consents and before randomization to a specific arm of the study, our participants had a qualifying DXA scan done at the University of California, San Francisco (UCSF) research DXA facility to qualify them for further screening. If eligible by DXA, potential participants had their medical history and chart thoroughly reviewed, along with a physical exam, and screening blood and urine tests done.
Participant milestones
| Measure |
Combination Therapy Arm: Teriparatide (TPTD) + the Calcimimetic Cinacalcet
Combination therapy arm: Men randomized to this arm will take daily subcutaneous injections of teriparatide \[PTH (1-34)\] (20 mcg per day) and at the same time swallow a 30-mg tablet of cinacalcet. Men in both arms of the study will take a total of approximately 1000 mg elemental Ca through their diets and study provided Ca supplements (Ca citrate) and approximately 1000 IU vitamin D3. Men will be followed and assessed throughout the entire study using the clinical (vital signs, adverse events), laboratory (blood and urine tests) and densitometric procedures (DXA BMD and TBS) outlined in the study protocol.
|
Monotherapy Arm: Teriparatide (TPTD) + Placebo
Monotherapy arm: Men randomized to this arm will take daily subcutaneous injections of teriparatide \[PTH (1-34)\] (20 mcg per day) and at the same time swallow a placebo tablet. Men in both arms of the study will take a total of approximately 1000 mg elemental Ca through their diets and study provided Ca supplements (Ca citrate) and approximately 1000 IU vitamin D3. Men will be followed and assessed throughout the entire study using the clinical (vital signs, adverse events), laboratory (blood and urine tests) and densitometric procedures (DXA BMD and TBS) outlined in the study protocol.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
18
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Combination Therapy Arm: Teriparatide (TPTD) + the Calcimimetic Cinacalcet
Combination therapy arm: Men randomized to this arm will take daily subcutaneous injections of teriparatide \[PTH (1-34)\] (20 mcg per day) and at the same time swallow a 30-mg tablet of cinacalcet. Men in both arms of the study will take a total of approximately 1000 mg elemental Ca through their diets and study provided Ca supplements (Ca citrate) and approximately 1000 IU vitamin D3. Men will be followed and assessed throughout the entire study using the clinical (vital signs, adverse events), laboratory (blood and urine tests) and densitometric procedures (DXA BMD and TBS) outlined in the study protocol.
|
Monotherapy Arm: Teriparatide (TPTD) + Placebo
Monotherapy arm: Men randomized to this arm will take daily subcutaneous injections of teriparatide \[PTH (1-34)\] (20 mcg per day) and at the same time swallow a placebo tablet. Men in both arms of the study will take a total of approximately 1000 mg elemental Ca through their diets and study provided Ca supplements (Ca citrate) and approximately 1000 IU vitamin D3. Men will be followed and assessed throughout the entire study using the clinical (vital signs, adverse events), laboratory (blood and urine tests) and densitometric procedures (DXA BMD and TBS) outlined in the study protocol.
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Novel Combination Therapy for Osteoporosis in Men
Baseline characteristics by cohort
| Measure |
Combination Therapy Arm: Teriparatide (TPTD) + the Calcimimetic Cinacalcet
n=20 Participants
Combination therapy arm: Men randomized to this arm will take daily subcutaneous injections of teriparatide \[PTH (1-34)\] (20 mcg per day) and at the same time swallow a 30-mg tablet of cinacalcet. Men in both arms of the study will take a total of approximately 1000 mg elemental Ca through their diets and study provided Ca supplements (Ca citrate) and approximately 1000 IU vitamin D3. Men will be followed and assessed throughout the entire study using the clinical (vital signs, adverse events), laboratory (blood and urine tests) and densitometric procedures (DXA BMD and TBS) outlined in the study protocol.
|
Monotherapy Arm: Teriparatide (TPTD) + Placebo
n=20 Participants
Monotherapy arm: Men randomized to this arm will take daily subcutaneous injections of teriparatide \[PTH (1-34)\] (20 mcg per day) and at the same time swallow a placebo tablet. Men in both arms of the study will take a total of approximately 1000 mg elemental Ca through their diets and study provided Ca supplements (Ca citrate) and approximately 1000 IU vitamin D3. Men will be followed and assessed throughout the entire study using the clinical (vital signs, adverse events), laboratory (blood and urine tests) and densitometric procedures (DXA BMD and TBS) outlined in the study protocol.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=136 Participants
|
5 Participants
n=136 Participants
|
12 Participants
n=272 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=136 Participants
|
15 Participants
n=136 Participants
|
28 Participants
n=272 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=136 Participants
|
20 Participants
n=136 Participants
|
40 Participants
n=272 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=136 Participants
|
1 Participants
n=136 Participants
|
2 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=136 Participants
|
2 Participants
n=136 Participants
|
4 Participants
n=272 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=136 Participants
|
17 Participants
n=136 Participants
|
33 Participants
n=272 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Lumbar spine bone mineral density by dual energy xray absorptiometry
|
0.918 g/cm^2
STANDARD_DEVIATION 0.124 • n=136 Participants
|
0.952 g/cm^2
STANDARD_DEVIATION 0.121 • n=136 Participants
|
0.935 g/cm^2
STANDARD_DEVIATION 0.120 • n=272 Participants
|
|
femoral neck bone mineral density by dual energy xray absorptiometry
|
0.614 g/cm^2
STANDARD_DEVIATION 0.091 • n=136 Participants
|
0.657 g/cm^2
STANDARD_DEVIATION 0.069 • n=136 Participants
|
0.636 g/cm^2
STANDARD_DEVIATION 0.0813 • n=272 Participants
|
PRIMARY outcome
Timeframe: 48 weeksPopulation: 20 participants were randomized to the Combination Arm and to the Teriparatide + Placebo Arm. One participant in the Combination Arm died during the study from an unrelated cause and final bone mineral density measurement could not be obtained. Thus, 20 participants were randomized but final data were available on 19 in the Combination Arm of the study.
Hypothesis 1a proposes that BMD responses to combined TPTD+cinacalcet are greater than those induced by TPTD+PBO. LS BMD typically responds quickly and robustly to TPTD and is the 1o endpoint of the trial. DXA measurements will be performed and analyzed by standard protocols at baseline and at the end of the trial. Subjects will be treated for 11 months (48 weeks). All subjects will receive Ca and vitamin D3 supplements throughout the trial. The percentage change in LS BMD from baseline to 48 week/11 months of treatment will be the variable/endpoint that is calculated.
Outcome measures
| Measure |
Combination Therapy Arm: Teriparatide (TPTD) + the Calcimimetic Cinacalcet
n=19 Participants
Combination therapy arm: Men randomized to this arm will take daily subcutaneous injections of teriparatide \[PTH (1-34)\] (20 mcg per day) and at the same time swallow a 30-mg tablet of cinacalcet. Men in both arms of the study will take a total of approximately 1000 mg elemental Ca through their diets and study provided Ca supplements (Ca citrate) and approximately 1000 IU vitamin D3. Men will be followed and assessed throughout the entire study using the clinical (vital signs, adverse events), laboratory (blood and urine tests) and densitometric procedures (DXA BMD and TBS) outlined in the study protocol.
|
Monotherapy Arm: Teriparatide (TPTD) + Placebo
n=20 Participants
Monotherapy arm: Men randomized to this arm will take daily subcutaneous injections of teriparatide \[PTH (1-34)\] (20 mcg per day) and at the same time swallow a placebo tablet. Men in both arms of the study will take a total of approximately 1000 mg elemental Ca through their diets and study provided Ca supplements (Ca citrate) and approximately 1000 IU vitamin D3. Men will be followed and assessed throughout the entire study using the clinical (vital signs, adverse events), laboratory (blood and urine tests) and densitometric procedures (DXA BMD and TBS) outlined in the study protocol.
|
|---|---|---|
|
Effects of Treatment With TPTD+Cinacalcet Compared to TPTD+PBO on Lumbar Spine BMD in Men With Low Bone Mass
|
6.1 percent change
Standard Deviation 4.6
|
5.8 percent change
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 20 participants were randomized to the Combination Treatment Group and 20 participants randomized to the Monotherapy Group. The data displayed are for 20 subjects per Arm or per the 2 study groups.
Hypothesis 1b proposes that serum P1NP (N-terminal pro-peptide of type 1 collagen), a highly sensitive marker of bone turnover and specifically of bone formation, will increase to a greater extent in men treated with TPTD+cinacalcet vs TPTD+PBO. Serum P1NP is the best validated biomarker of TPTD action and responds rapidly and robustly to anabolic therapy. This secondary endpoint will be assessed at the 3 month/12 week visit in the fasting state on morning lab tests (prior to study drug administration). The endpoint is a blood test of bone formation marker comparing results from Day 1/Randomization Visit to Study Visit at 3 months/12 weeks. The percentage change in this bone formation marker will be the variable that will constitute this secondary endpoint.
Outcome measures
| Measure |
Combination Therapy Arm: Teriparatide (TPTD) + the Calcimimetic Cinacalcet
n=20 Participants
Combination therapy arm: Men randomized to this arm will take daily subcutaneous injections of teriparatide \[PTH (1-34)\] (20 mcg per day) and at the same time swallow a 30-mg tablet of cinacalcet. Men in both arms of the study will take a total of approximately 1000 mg elemental Ca through their diets and study provided Ca supplements (Ca citrate) and approximately 1000 IU vitamin D3. Men will be followed and assessed throughout the entire study using the clinical (vital signs, adverse events), laboratory (blood and urine tests) and densitometric procedures (DXA BMD and TBS) outlined in the study protocol.
|
Monotherapy Arm: Teriparatide (TPTD) + Placebo
n=20 Participants
Monotherapy arm: Men randomized to this arm will take daily subcutaneous injections of teriparatide \[PTH (1-34)\] (20 mcg per day) and at the same time swallow a placebo tablet. Men in both arms of the study will take a total of approximately 1000 mg elemental Ca through their diets and study provided Ca supplements (Ca citrate) and approximately 1000 IU vitamin D3. Men will be followed and assessed throughout the entire study using the clinical (vital signs, adverse events), laboratory (blood and urine tests) and densitometric procedures (DXA BMD and TBS) outlined in the study protocol.
|
|---|---|---|
|
Effects of Treatment With TPTD+Cinacalcet Compared to TPTD+PBO on Serum P1NP in Men With Low Bone Mass
|
175 percent change
Standard Deviation 98
|
171 percent change
Standard Deviation 129
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: There were 20 participants randomized to the Monotherapy Group and 20 participants randomized to the Combination Therapy Group. 20/20 finished the study in the Monotherapy Group and 19/20 finished the study in the Combination Therapy group.
Hypothesis 1a also proposes femoral neck BMD responses to combined TPTD+cinacalcet are greater than those induced by TPTD+PBO. FN BMD responses tend to be smaller than LS BMD responses to TPTD and this aim will test whether the combination therapy (CaSR activation + PTH-R activation) will produce larger BMD responses at the FN site in men with low BMD. The percentage change in FN BMD from baseline to 48 week/11 months of treatment will be the variable/endpoint that is calculated.
Outcome measures
| Measure |
Combination Therapy Arm: Teriparatide (TPTD) + the Calcimimetic Cinacalcet
n=19 Participants
Combination therapy arm: Men randomized to this arm will take daily subcutaneous injections of teriparatide \[PTH (1-34)\] (20 mcg per day) and at the same time swallow a 30-mg tablet of cinacalcet. Men in both arms of the study will take a total of approximately 1000 mg elemental Ca through their diets and study provided Ca supplements (Ca citrate) and approximately 1000 IU vitamin D3. Men will be followed and assessed throughout the entire study using the clinical (vital signs, adverse events), laboratory (blood and urine tests) and densitometric procedures (DXA BMD and TBS) outlined in the study protocol.
|
Monotherapy Arm: Teriparatide (TPTD) + Placebo
n=20 Participants
Monotherapy arm: Men randomized to this arm will take daily subcutaneous injections of teriparatide \[PTH (1-34)\] (20 mcg per day) and at the same time swallow a placebo tablet. Men in both arms of the study will take a total of approximately 1000 mg elemental Ca through their diets and study provided Ca supplements (Ca citrate) and approximately 1000 IU vitamin D3. Men will be followed and assessed throughout the entire study using the clinical (vital signs, adverse events), laboratory (blood and urine tests) and densitometric procedures (DXA BMD and TBS) outlined in the study protocol.
|
|---|---|---|
|
Effects of Treatment With TPTD+Cinacalcet Compared to TPTD+PBO on Femoral Neck BMD in Men With Low Bone Mass
|
0.4 percent change
Standard Deviation 5.7
|
2.4 percent change
Standard Deviation 4.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 hours during the Randomization VisitPopulation: Although 20 participants were randomized to the Combination Group and 20 participants were randomized to the Monotherapy Group, there were just 12 participants in each of the treatment groups who underwent acute pharmacodynamic testing at the Randomization Visit (per Protocol) and reported on in this table. The top row is time 0 (Baseline), second row is 1 hour, third row is 2 hours, fourth row is 4 hours, and fifth row is 8 hours after study drugs are administered.
serum calcium was measured during the 8 hours pharmacodynamic testing at randomization visit
Outcome measures
| Measure |
Combination Therapy Arm: Teriparatide (TPTD) + the Calcimimetic Cinacalcet
n=12 Participants
Combination therapy arm: Men randomized to this arm will take daily subcutaneous injections of teriparatide \[PTH (1-34)\] (20 mcg per day) and at the same time swallow a 30-mg tablet of cinacalcet. Men in both arms of the study will take a total of approximately 1000 mg elemental Ca through their diets and study provided Ca supplements (Ca citrate) and approximately 1000 IU vitamin D3. Men will be followed and assessed throughout the entire study using the clinical (vital signs, adverse events), laboratory (blood and urine tests) and densitometric procedures (DXA BMD and TBS) outlined in the study protocol.
|
Monotherapy Arm: Teriparatide (TPTD) + Placebo
n=12 Participants
Monotherapy arm: Men randomized to this arm will take daily subcutaneous injections of teriparatide \[PTH (1-34)\] (20 mcg per day) and at the same time swallow a placebo tablet. Men in both arms of the study will take a total of approximately 1000 mg elemental Ca through their diets and study provided Ca supplements (Ca citrate) and approximately 1000 IU vitamin D3. Men will be followed and assessed throughout the entire study using the clinical (vital signs, adverse events), laboratory (blood and urine tests) and densitometric procedures (DXA BMD and TBS) outlined in the study protocol.
|
|---|---|---|
|
Mean Serum Calcium During Acute Pharmacodynamic Testing
Baseline mean serum calcium level before study drugs are given
|
9.25 mg per deciliter
Standard Deviation 0.37
|
9.26 mg per deciliter
Standard Deviation 0.31
|
|
Mean Serum Calcium During Acute Pharmacodynamic Testing
Mean serum calcium 1 hour after study drugs are given
|
9.30 mg per deciliter
Standard Deviation 0.31
|
9.26 mg per deciliter
Standard Deviation 0.26
|
|
Mean Serum Calcium During Acute Pharmacodynamic Testing
Mean serum calcium level 2 hours after study drugs are given
|
9.27 mg per deciliter
Standard Deviation 0.35
|
9.34 mg per deciliter
Standard Deviation 0.26
|
|
Mean Serum Calcium During Acute Pharmacodynamic Testing
Mean serum calcium level 4 hours after study drugs are given
|
9.34 mg per deciliter
Standard Deviation 0.44
|
9.34 mg per deciliter
Standard Deviation 0.28
|
|
Mean Serum Calcium During Acute Pharmacodynamic Testing
Mean serum calcium level 8 hours after study drugs are given
|
9.24 mg per deciliter
Standard Deviation 0.33
|
9.35 mg per deciliter
Standard Deviation 0.19
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 48 weeksPopulation: 20 participants were randomized into the Combination Group and into the Monotherapy Arm/Group. One participant withdrew at approximately week 12 in the Combination Group and 1 participant died from unrelated causes in the Combination Group after week 24, so that total number of measurements decreases from 20 to 18 by the end of the study in the Combination Group. There are 20 participants' data at every study visit in the Monotherapy Arm/Group and no participants withdrew or left the study.
Mean serum calcium (mg per deciliter) was measured at every study visit
Outcome measures
| Measure |
Combination Therapy Arm: Teriparatide (TPTD) + the Calcimimetic Cinacalcet
n=20 Participants
Combination therapy arm: Men randomized to this arm will take daily subcutaneous injections of teriparatide \[PTH (1-34)\] (20 mcg per day) and at the same time swallow a 30-mg tablet of cinacalcet. Men in both arms of the study will take a total of approximately 1000 mg elemental Ca through their diets and study provided Ca supplements (Ca citrate) and approximately 1000 IU vitamin D3. Men will be followed and assessed throughout the entire study using the clinical (vital signs, adverse events), laboratory (blood and urine tests) and densitometric procedures (DXA BMD and TBS) outlined in the study protocol.
|
Monotherapy Arm: Teriparatide (TPTD) + Placebo
n=20 Participants
Monotherapy arm: Men randomized to this arm will take daily subcutaneous injections of teriparatide \[PTH (1-34)\] (20 mcg per day) and at the same time swallow a placebo tablet. Men in both arms of the study will take a total of approximately 1000 mg elemental Ca through their diets and study provided Ca supplements (Ca citrate) and approximately 1000 IU vitamin D3. Men will be followed and assessed throughout the entire study using the clinical (vital signs, adverse events), laboratory (blood and urine tests) and densitometric procedures (DXA BMD and TBS) outlined in the study protocol.
|
|---|---|---|
|
Mean Serum Calcium During 48 Weeks of Study Visits
Mean serum calcium at time 8 weeks
|
8.82 mg per deciliter
Interval 8.64 to 9.0
|
9.49 mg per deciliter
Interval 9.33 to 9.64
|
|
Mean Serum Calcium During 48 Weeks of Study Visits
Mean serum calcium at time 12 weeks
|
8.90 mg per deciliter
Interval 8.72 to 9.1
|
9.40 mg per deciliter
Interval 9.21 to 9.59
|
|
Mean Serum Calcium During 48 Weeks of Study Visits
Mean serum calcium at time 20 weeks
|
8.92 mg per deciliter
Interval 8.75 to 9.1
|
9.46 mg per deciliter
Interval 9.3 to 9.62
|
|
Mean Serum Calcium During 48 Weeks of Study Visits
Mean serum calcium at time 24 weeks
|
8.92 mg per deciliter
Interval 8.74 to 9.1
|
9.47 mg per deciliter
Interval 9.29 to 9.66
|
|
Mean Serum Calcium During 48 Weeks of Study Visits
Mean serum calcium at time 36 weeks
|
8.81 mg per deciliter
Interval 8.6 to 9.02
|
9.60 mg per deciliter
Interval 9.46 to 9.75
|
|
Mean Serum Calcium During 48 Weeks of Study Visits
Mean serum calcium at time 0 (baseline)
|
9.25 mg per deciliter
Interval 9.1 to 9.41
|
9.35 mg per deciliter
Interval 9.21 to 9.48
|
|
Mean Serum Calcium During 48 Weeks of Study Visits
Mean serum calcium at time 4 weeks
|
8.71 mg per deciliter
Interval 8.45 to 9.0
|
9.38 mg per deciliter
Interval 9.2 to 9.56
|
|
Mean Serum Calcium During 48 Weeks of Study Visits
Mean serum calcium at time 48 weeks
|
8.85 mg per deciliter
Interval 8.69 to 9.01
|
9.48 mg per deciliter
Interval 9.32 to 9.64
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 48 weeksPopulation: 20 participants were randomized to the Combination Therapy Arm and 20 participants randomized to the Monotherapy Arm. During the study, 1 participant withdrew from the Combination Therapy Arm at 12 weeks into the study, and another participant died during the study (unrelated), also in the Combination Therapy Arm. Thus, the number of participants declined from 20 to 19, and then 19 to 18 in the Combination Therapy Arm, but was constant at 20 in the Monotherapy Arm.
Mean 24 hour urine calcium at each study visit during 48 weeks of the study
Outcome measures
| Measure |
Combination Therapy Arm: Teriparatide (TPTD) + the Calcimimetic Cinacalcet
n=20 Participants
Combination therapy arm: Men randomized to this arm will take daily subcutaneous injections of teriparatide \[PTH (1-34)\] (20 mcg per day) and at the same time swallow a 30-mg tablet of cinacalcet. Men in both arms of the study will take a total of approximately 1000 mg elemental Ca through their diets and study provided Ca supplements (Ca citrate) and approximately 1000 IU vitamin D3. Men will be followed and assessed throughout the entire study using the clinical (vital signs, adverse events), laboratory (blood and urine tests) and densitometric procedures (DXA BMD and TBS) outlined in the study protocol.
|
Monotherapy Arm: Teriparatide (TPTD) + Placebo
n=20 Participants
Monotherapy arm: Men randomized to this arm will take daily subcutaneous injections of teriparatide \[PTH (1-34)\] (20 mcg per day) and at the same time swallow a placebo tablet. Men in both arms of the study will take a total of approximately 1000 mg elemental Ca through their diets and study provided Ca supplements (Ca citrate) and approximately 1000 IU vitamin D3. Men will be followed and assessed throughout the entire study using the clinical (vital signs, adverse events), laboratory (blood and urine tests) and densitometric procedures (DXA BMD and TBS) outlined in the study protocol.
|
|---|---|---|
|
Total Urinary Calcium Excretion During 48 Weeks of Study
24 hour urine calcium excretion at 8 week study visit
|
208.7 mg per 24 hours
Interval 162.2 to 255.3
|
192.2 mg per 24 hours
Interval 143.4 to 240.9
|
|
Total Urinary Calcium Excretion During 48 Weeks of Study
24 hour urine calcium excretion at 12 week study visit
|
252.3 mg per 24 hours
Interval 208.5 to 296.1
|
216.4 mg per 24 hours
Interval 165.5 to 267.3
|
|
Total Urinary Calcium Excretion During 48 Weeks of Study
24 hour urine calcium excretion at 24 week study visit
|
244.0 mg per 24 hours
Interval 195.4 to 292.6
|
205.6 mg per 24 hours
Interval 151.0 to 260.2
|
|
Total Urinary Calcium Excretion During 48 Weeks of Study
24 hour urine calcium excretion at 36 week study visit
|
235.6 mg per 24 hours
Interval 179.6 to 291.5
|
231.9 mg per 24 hours
Interval 173.6 to 290.2
|
|
Total Urinary Calcium Excretion During 48 Weeks of Study
24 hour urine calcium excretion at 48 week study visit
|
215.0 mg per 24 hours
Interval 171.6 to 258.3
|
200.1 mg per 24 hours
Interval 146.1 to 254.1
|
|
Total Urinary Calcium Excretion During 48 Weeks of Study
Baseline 24 hour urine calcium excretion
|
211.6 mg per 24 hours
Interval 147.8 to 275.3
|
156.6 mg per 24 hours
Interval 111.7 to 201.6
|
|
Total Urinary Calcium Excretion During 48 Weeks of Study
24 hour urine calcium excretion at 4 week study visit
|
215.4 mg per 24 hours
Interval 164.6 to 266.3
|
172.9 mg per 24 hours
Interval 129.8 to 216.1
|
Adverse Events
Combination Therapy Arm: Teriparatide (TPTD) + the Calcimimetic Cinacalcet
Serious events: 3 serious events
Other events: 20 other events
Deaths: 1 deaths
Monotherapy Arm: Teriparatide (TPTD) + Placebo
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Combination Therapy Arm: Teriparatide (TPTD) + the Calcimimetic Cinacalcet
n=20 participants at risk
Combination therapy arm: Men randomized to this arm will take daily subcutaneous injections of teriparatide \[PTH (1-34)\] (20 mcg per day) and at the same time swallow a 30-mg tablet of cinacalcet. Men in both arms of the study will take a total of approximately 1000 mg elemental Ca through their diets and study provided Ca supplements (Ca citrate) and approximately 1000 IU vitamin D3. Men will be followed and assessed throughout the entire study using the clinical (vital signs, adverse events), laboratory (blood and urine tests) and densitometric procedures (DXA BMD and TBS) outlined in the study protocol.
|
Monotherapy Arm: Teriparatide (TPTD) + Placebo
n=20 participants at risk
Monotherapy arm: Men randomized to this arm will take daily subcutaneous injections of teriparatide \[PTH (1-34)\] (20 mcg per day) and at the same time swallow a placebo tablet. Men in both arms of the study will take a total of approximately 1000 mg elemental Ca through their diets and study provided Ca supplements (Ca citrate) and approximately 1000 IU vitamin D3. Men will be followed and assessed throughout the entire study using the clinical (vital signs, adverse events), laboratory (blood and urine tests) and densitometric procedures (DXA BMD and TBS) outlined in the study protocol.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Cardiac disorders
Chest pain-cardiac
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Injury, poisoning and procedural complications
OTHER- PROCEDURE
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis-Death
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Injury, poisoning and procedural complications
FRACTURE
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
Other adverse events
| Measure |
Combination Therapy Arm: Teriparatide (TPTD) + the Calcimimetic Cinacalcet
n=20 participants at risk
Combination therapy arm: Men randomized to this arm will take daily subcutaneous injections of teriparatide \[PTH (1-34)\] (20 mcg per day) and at the same time swallow a 30-mg tablet of cinacalcet. Men in both arms of the study will take a total of approximately 1000 mg elemental Ca through their diets and study provided Ca supplements (Ca citrate) and approximately 1000 IU vitamin D3. Men will be followed and assessed throughout the entire study using the clinical (vital signs, adverse events), laboratory (blood and urine tests) and densitometric procedures (DXA BMD and TBS) outlined in the study protocol.
|
Monotherapy Arm: Teriparatide (TPTD) + Placebo
n=20 participants at risk
Monotherapy arm: Men randomized to this arm will take daily subcutaneous injections of teriparatide \[PTH (1-34)\] (20 mcg per day) and at the same time swallow a placebo tablet. Men in both arms of the study will take a total of approximately 1000 mg elemental Ca through their diets and study provided Ca supplements (Ca citrate) and approximately 1000 IU vitamin D3. Men will be followed and assessed throughout the entire study using the clinical (vital signs, adverse events), laboratory (blood and urine tests) and densitometric procedures (DXA BMD and TBS) outlined in the study protocol.
|
|---|---|---|
|
Endocrine disorders
HYPOTHYROIDISM
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Endocrine disorders
OTHER-ENDOCRINE-HIGH 25 OH VITAMIN D
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Endocrine disorders
OTHER-ENDOCRINE-LOW 25 OH VITAMIN D
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Gastrointestinal disorders
NAUSEA
|
25.0%
5/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
10.0%
2/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Gastrointestinal disorders
DIARRHEA
|
15.0%
3/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
10.0%
2/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
10.0%
2/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Gastrointestinal disorders
CONSTIPATION
|
10.0%
2/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
20.0%
4/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Gastrointestinal disorders
TOOTHACHE
|
10.0%
2/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
45.0%
9/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
35.0%
7/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
15.0%
3/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
10.0%
2/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
20.0%
4/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Musculoskeletal and connective tissue disorders
CHEST WALL PAIN
|
10.0%
2/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Musculoskeletal and connective tissue disorders
OTHER- MUSCULOSKELETAL
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Renal and urinary disorders
URINARY RETENTION
|
10.0%
2/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Renal and urinary disorders
OTHER- RENAL
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Renal and urinary disorders
HEMATURIA
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
40.0%
8/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Metabolism and nutrition disorders
HYPERCALCEMIA
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
10.0%
2/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Metabolism and nutrition disorders
OTHER- METABOLISM- HYPERCALCIURIA
|
35.0%
7/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
25.0%
5/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Metabolism and nutrition disorders
HYPOGLYCEMIA
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Metabolism and nutrition disorders
HYPOMAGNESEMIA
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Metabolism and nutrition disorders
HYPERKALEMIA
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Skin and subcutaneous tissue disorders
OTHER- SKIN
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Skin and subcutaneous tissue disorders
PRURITIS
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
10.0%
2/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Skin and subcutaneous tissue disorders
HYPERPIGMENTATION
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Skin and subcutaneous tissue disorders
OTHER-SKIN
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Nervous system disorders
PARASTHESIA
|
10.0%
2/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Nervous system disorders
OTHER- NERVOUS SYSTEM
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Nervous system disorders
HEADACHE
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Nervous system disorders
TREMOR
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Nervous system disorders
DIZZINESS
|
10.0%
2/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Infections and infestations
OTHER- INFECTIONS
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
35.0%
7/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Infections and infestations
UPPER RESPIRATORY INFECTION
|
15.0%
3/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Infections and infestations
SINUSITIS
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Infections and infestations
NAIL INFECTION
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Ear and labyrinth disorders
HEARING IMPAIRED
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Ear and labyrinth disorders
TINNITUS
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Eye disorders
CONJUNCTIVITIS
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Eye disorders
EYELID FUNCTION DISORDER
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Eye disorders
BLURRED VISION
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Eye disorders
GLAUCOMA
|
10.0%
2/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
General disorders
INJECTION SITE REACTION
|
30.0%
6/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
10.0%
2/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
General disorders
FATIGUE
|
10.0%
2/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
General disorders
PAIN
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Surgical and medical procedures
OTHER- PROCEDURE
|
10.0%
2/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Cardiac disorders
PALPITATIONS
|
15.0%
3/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHEA
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Respiratory, thoracic and mediastinal disorders
VOICE ALTERATION
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Psychiatric disorders
DEPRESSION
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Psychiatric disorders
INSOMNIA
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Injury, poisoning and procedural complications
FALL
|
25.0%
5/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Injury, poisoning and procedural complications
FRACTURE
|
10.0%
2/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
|
Injury, poisoning and procedural complications
OTHER
|
5.0%
1/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
0.00%
0/20 • adverse events were assessed after Informed Consent documents were signed and at every study visit and every encounter with a participant. This would average about 56 weeks of observation for each participant randomized.
|
Additional Information
Dolores Shoback MD
San Francisco Veterans Affairs Medical Center
Phone: 415-221-4810
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place