Trial Outcomes & Findings for Starting a Testosterone and Exercise Program After Hip Injury (NCT NCT02938923)
NCT ID: NCT02938923
Last Updated: 2025-02-04
Results Overview
Walking endurance was measured using a 6-Minute Walk Distance. Participants were asked to walk back and forth on a measured path marked clearly at both ends for turning purposes, while being told when each minute has passed, and receiving verbal encouragement every 60 seconds. Total distance was measured in meters with higher distances equating to higher walking endurance. Each individual participant distance from Baseline was subtracted from Month 6 to represent change over the length of the study. Higher positive values represent more improvement in walking distance. In addition to the primary analysis (unadjusted baseline to 6 month comparison), statistical contracts were evaluated to determine if there was significant between-group differences in the change from baseline to 3 months and additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
129 participants
Primary outcome timeframe
Baseline to 6 months
Results posted on
2025-02-04
Participant Flow
Between August 2018 and February 2023, participants identified from hospital records or referred from physicians/rehabilitation staff at 8 academic medical centers, were approached 6-24 weeks following hip repair surgery. If eligible by chart review, participants were pre-screened, consented for full study, screened, and completed baseline assessments, prior to randomization. The first participant was randomized in March 2019 and the final participant randomized in February 2023.
4695 charts were reviewed. 907 were eligible by chart review and 344 agreed to complete the pre-screening questionnaire. Of those, 28 failed, another 42 were deemed ineligible after further review, 7 refused to review the consent, and 60 refused consent. Leaving 207 who consented for screening, of which 12 refused to continue to screening visit and 10 were found ineligible prior to screening. 185 screened, of whom 32 screen failed, 7 refused after screening, and 17 were ineligible to randomize.
Participant milestones
| Measure |
Exercise + Testosterone (EX + T)
Supervised exercise training 2 times per week and topical testosterone 1% gel (12.5 mg per pump depression), both for six months duration.
Testosterone: Topical testosterone gel 1%
Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training
|
Exercise + Placebo (EX + P)
Supervised exercise training 2 times per week and placebo gel daily, both for six months duration.
Placebo gel: Inactive skin gel
Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training
|
Enhanced Usual Care (EUC)
Home exercise program 3 times per week and monthly health education modules, both for six months duration.
Home exercise program: Flexibility exercises performed at home 3 times per week and reviewed by study staff once a month.
Health Education Modules: 30-40 minute presentations conducted by study staff for participants focused on health concerns unrelated to exercise.
|
|---|---|---|---|
|
Overall Study
STARTED
|
55
|
54
|
20
|
|
Overall Study
COMPLETED
|
54
|
51
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
1
|
Reasons for withdrawal
| Measure |
Exercise + Testosterone (EX + T)
Supervised exercise training 2 times per week and topical testosterone 1% gel (12.5 mg per pump depression), both for six months duration.
Testosterone: Topical testosterone gel 1%
Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training
|
Exercise + Placebo (EX + P)
Supervised exercise training 2 times per week and placebo gel daily, both for six months duration.
Placebo gel: Inactive skin gel
Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training
|
Enhanced Usual Care (EUC)
Home exercise program 3 times per week and monthly health education modules, both for six months duration.
Home exercise program: Flexibility exercises performed at home 3 times per week and reviewed by study staff once a month.
Health Education Modules: 30-40 minute presentations conducted by study staff for participants focused on health concerns unrelated to exercise.
|
|---|---|---|---|
|
Overall Study
Death
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
Baseline Characteristics
7 participants attempted, but were unable to complete the 1-RM (unable to move the weight at all) and 2 participants refused to attempt the measure.
Baseline characteristics by cohort
| Measure |
Exercise + Testosterone (EX + T)
n=55 Participants
Supervised exercise training 2 times per week and topical testosterone 1% gel (12.5 mg per pump depression), both for six months duration.
Testosterone: Topical testosterone gel 1%
Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training
|
Exercise + Placebo (EX + P)
n=54 Participants
Supervised exercise training 2 times per week and placebo gel daily, both for six months duration.
Placebo gel: Inactive skin gel
Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training
|
Enhanced Usual Care (EUC)
n=20 Participants
Home exercise program 3 times per week and monthly health education modules, both for six months duration.
Home exercise program: Flexibility exercises performed at home 3 times per week and reviewed by study staff once a month.
Health Education Modules: 30-40 minute presentations conducted by study staff for participants focused on health concerns unrelated to exercise.
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
79.42 years
STANDARD_DEVIATION 9.08 • n=55 Participants
|
78.28 years
STANDARD_DEVIATION 7.52 • n=54 Participants
|
82.98 years
STANDARD_DEVIATION 8.39 • n=20 Participants
|
79.49 years
STANDARD_DEVIATION 8.43 • n=129 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=55 Participants
|
54 Participants
n=54 Participants
|
20 Participants
n=20 Participants
|
129 Participants
n=129 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=55 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=129 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=55 Participants
|
3 Participants
n=54 Participants
|
1 Participants
n=20 Participants
|
5 Participants
n=129 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
54 Participants
n=55 Participants
|
48 Participants
n=54 Participants
|
18 Participants
n=20 Participants
|
120 Participants
n=129 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=55 Participants
|
3 Participants
n=54 Participants
|
1 Participants
n=20 Participants
|
4 Participants
n=129 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=55 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=55 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=55 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=55 Participants
|
3 Participants
n=54 Participants
|
1 Participants
n=20 Participants
|
6 Participants
n=129 Participants
|
|
Race (NIH/OMB)
White
|
52 Participants
n=55 Participants
|
49 Participants
n=54 Participants
|
19 Participants
n=20 Participants
|
120 Participants
n=129 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=55 Participants
|
1 Participants
n=54 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=55 Participants
|
1 Participants
n=54 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=129 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=55 Participants
|
54 participants
n=54 Participants
|
20 participants
n=20 Participants
|
129 participants
n=129 Participants
|
|
Site
Hebrew SeniorLife (HSL)/Beth Israel (BI)/Harvard Medical School
|
17 Participants
n=55 Participants
|
16 Participants
n=54 Participants
|
5 Participants
n=20 Participants
|
38 Participants
n=129 Participants
|
|
Site
Washington University in St. Louis (WashU)
|
9 Participants
n=55 Participants
|
12 Participants
n=54 Participants
|
5 Participants
n=20 Participants
|
26 Participants
n=129 Participants
|
|
Site
University of Colorado - Denver (UCD)
|
1 Participants
n=55 Participants
|
0 Participants
n=54 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=129 Participants
|
|
Site
University of Connecticut (UConn Health)
|
11 Participants
n=55 Participants
|
11 Participants
n=54 Participants
|
4 Participants
n=20 Participants
|
26 Participants
n=129 Participants
|
|
Site
University of Maryland Baltimore/Johns Hopkins University (UM/JH)
|
1 Participants
n=55 Participants
|
0 Participants
n=54 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=129 Participants
|
|
Site
University of Texas Medical Branch at Galveston (UTMB)
|
8 Participants
n=55 Participants
|
7 Participants
n=54 Participants
|
1 Participants
n=20 Participants
|
16 Participants
n=129 Participants
|
|
Site
University of Utah Health (UofU)
|
5 Participants
n=55 Participants
|
4 Participants
n=54 Participants
|
0 Participants
n=20 Participants
|
9 Participants
n=129 Participants
|
|
Site
University of Pittsburgh (Pitt)/University of Pittsburgh Medical Center (UPMC)
|
3 Participants
n=55 Participants
|
4 Participants
n=54 Participants
|
1 Participants
n=20 Participants
|
8 Participants
n=129 Participants
|
|
Time from hip surgery to baseline start date
|
98.29 days
STANDARD_DEVIATION 32.52 • n=55 Participants
|
108.54 days
STANDARD_DEVIATION 33.42 • n=54 Participants
|
89.65 days
STANDARD_DEVIATION 21.62 • n=20 Participants
|
101.24 days
STANDARD_DEVIATION 32.02 • n=129 Participants
|
|
Type of Fracture
Intertrochanteric Fracture
|
23 Participants
n=55 Participants
|
23 Participants
n=54 Participants
|
13 Participants
n=20 Participants
|
59 Participants
n=129 Participants
|
|
Type of Fracture
Intracapsular or Femoral Neck Fracture
|
25 Participants
n=55 Participants
|
22 Participants
n=54 Participants
|
3 Participants
n=20 Participants
|
50 Participants
n=129 Participants
|
|
Type of Fracture
Subtrochanteric Fracture
|
7 Participants
n=55 Participants
|
9 Participants
n=54 Participants
|
4 Participants
n=20 Participants
|
20 Participants
n=129 Participants
|
|
Body mass index (BMI)
|
25.61 Kilograms/meters ^2 (kg/m^2)
STANDARD_DEVIATION 5.49 • n=55 Participants
|
26.89 Kilograms/meters ^2 (kg/m^2)
STANDARD_DEVIATION 5.02 • n=54 Participants
|
24.43 Kilograms/meters ^2 (kg/m^2)
STANDARD_DEVIATION 3.36 • n=20 Participants
|
25.96 Kilograms/meters ^2 (kg/m^2)
STANDARD_DEVIATION 5.06 • n=129 Participants
|
|
History of Lung Disease
No lung disease
|
51 Participants
n=55 Participants
|
51 Participants
n=54 Participants
|
16 Participants
n=20 Participants
|
118 Participants
n=129 Participants
|
|
History of Lung Disease
lung disease
|
4 Participants
n=55 Participants
|
3 Participants
n=54 Participants
|
4 Participants
n=20 Participants
|
11 Participants
n=129 Participants
|
|
Co-morbidity count
|
5.20 units on a scale
STANDARD_DEVIATION 3.09 • n=55 Participants
|
5.13 units on a scale
STANDARD_DEVIATION 2.52 • n=54 Participants
|
5.85 units on a scale
STANDARD_DEVIATION 3.17 • n=20 Participants
|
5.27 units on a scale
STANDARD_DEVIATION 2.86 • n=129 Participants
|
|
Geriatric Depression Scale (GDS)
|
1.84 unites on a scale
STANDARD_DEVIATION 1.75 • n=55 Participants
|
2.43 unites on a scale
STANDARD_DEVIATION 2.04 • n=54 Participants
|
3.15 unites on a scale
STANDARD_DEVIATION 2.62 • n=20 Participants
|
2.29 unites on a scale
STANDARD_DEVIATION 2.06 • n=129 Participants
|
|
Six Minute Walk Distance
|
267.77 meters
STANDARD_DEVIATION 86.60 • n=55 Participants
|
225.92 meters
STANDARD_DEVIATION 98.09 • n=54 Participants
|
206.37 meters
STANDARD_DEVIATION 76.82 • n=20 Participants
|
240.73 meters
STANDARD_DEVIATION 92.82 • n=129 Participants
|
|
Total lean body mass
|
36649.42 Grams
STANDARD_DEVIATION 5892.42 • n=55 Participants
|
37744.01 Grams
STANDARD_DEVIATION 5543.42 • n=54 Participants
|
35144.55 Grams
STANDARD_DEVIATION 4276.92 • n=20 Participants
|
36874.31 Grams
STANDARD_DEVIATION 5558.35 • n=129 Participants
|
|
Appendicular lean body mass
|
15650.59 Grams
STANDARD_DEVIATION 3045.80 • n=55 Participants
|
16276.07 Grams
STANDARD_DEVIATION 3078.32 • n=54 Participants
|
15070.01 Grams
STANDARD_DEVIATION 2279.41 • n=20 Participants
|
15822.42 Grams
STANDARD_DEVIATION 2965.91 • n=129 Participants
|
|
Leg Press 1-Repetition Maximum
|
97.12 Pounds
STANDARD_DEVIATION 53.86 • n=53 Participants • 7 participants attempted, but were unable to complete the 1-RM (unable to move the weight at all) and 2 participants refused to attempt the measure.
|
85.41 Pounds
STANDARD_DEVIATION 40.97 • n=49 Participants • 7 participants attempted, but were unable to complete the 1-RM (unable to move the weight at all) and 2 participants refused to attempt the measure.
|
88.61 Pounds
STANDARD_DEVIATION 55.16 • n=18 Participants • 7 participants attempted, but were unable to complete the 1-RM (unable to move the weight at all) and 2 participants refused to attempt the measure.
|
91.06 Pounds
STANDARD_DEVIATION 49.09 • n=120 Participants • 7 participants attempted, but were unable to complete the 1-RM (unable to move the weight at all) and 2 participants refused to attempt the measure.
|
|
Modified Physical Performance (mPPT) Score
|
20.85 units on a scale
STANDARD_DEVIATION 6.73 • n=55 Participants
|
20.37 units on a scale
STANDARD_DEVIATION 6.84 • n=54 Participants
|
17.55 units on a scale
STANDARD_DEVIATION 6.95 • n=20 Participants
|
20.14 units on a scale
STANDARD_DEVIATION 6.85 • n=129 Participants
|
|
Short Physical Performance Battery (SPPB)
|
6.95 units on a scale
STANDARD_DEVIATION 2.16 • n=55 Participants
|
6.63 units on a scale
STANDARD_DEVIATION 2.27 • n=54 Participants
|
5.45 units on a scale
STANDARD_DEVIATION 2.14 • n=20 Participants
|
6.58 units on a scale
STANDARD_DEVIATION 2.25 • n=129 Participants
|
|
Older Adult Resources and Services (OARS) Activities of Daily Living (ADL) Questionnaire
Basic Activities of Daily Living (BADL)
|
12.15 units on a scale
STANDARD_DEVIATION 1.67 • n=55 Participants
|
12.0 units on a scale
STANDARD_DEVIATION 2.01 • n=54 Participants
|
12.05 units on a scale
STANDARD_DEVIATION 1.76 • n=20 Participants
|
12.07 units on a scale
STANDARD_DEVIATION 1.82 • n=129 Participants
|
|
Older Adult Resources and Services (OARS) Activities of Daily Living (ADL) Questionnaire
Instrumental Activities of Daily Living (IADL)
|
11.51 units on a scale
STANDARD_DEVIATION 2.43 • n=55 Participants
|
11.28 units on a scale
STANDARD_DEVIATION 2.48 • n=54 Participants
|
11.35 units on a scale
STANDARD_DEVIATION 1.93 • n=20 Participants
|
11.39 units on a scale
STANDARD_DEVIATION 2.37 • n=129 Participants
|
|
Functional Status Questionnaire (FSQ)
|
23.16 units on a scale
STANDARD_DEVIATION 4.80 • n=55 Participants
|
21.80 units on a scale
STANDARD_DEVIATION 5.03 • n=54 Participants
|
21.30 units on a scale
STANDARD_DEVIATION 5.15 • n=20 Participants
|
22.30 units on a scale
STANDARD_DEVIATION 4.97 • n=129 Participants
|
|
Hip Rating Questionnaire (HRQ)
|
72.06 units on a scale
STANDARD_DEVIATION 12.36 • n=55 Participants
|
69.54 units on a scale
STANDARD_DEVIATION 10.227 • n=54 Participants
|
70.89 units on a scale
STANDARD_DEVIATION 11.87 • n=20 Participants
|
70.82 units on a scale
STANDARD_DEVIATION 11.42 • n=129 Participants
|
|
Bone mineral density (BMD) of non-fractured proximal femur
|
0.71 Grams/centimeters^2 (g/cm^2)
STANDARD_DEVIATION 0.12 • n=46 Participants • Only participants without hardware in their contralateral hip (opposite hip to the surgical repair conducted just prior to enrollment in the STEP-HI study) completed the DXA scan for BMD. A total of 9 EX+T, 6 EX+P, and 4 EUC participants were not scanned.
|
0.73 Grams/centimeters^2 (g/cm^2)
STANDARD_DEVIATION 0.12 • n=48 Participants • Only participants without hardware in their contralateral hip (opposite hip to the surgical repair conducted just prior to enrollment in the STEP-HI study) completed the DXA scan for BMD. A total of 9 EX+T, 6 EX+P, and 4 EUC participants were not scanned.
|
0.71 Grams/centimeters^2 (g/cm^2)
STANDARD_DEVIATION 0.12 • n=16 Participants • Only participants without hardware in their contralateral hip (opposite hip to the surgical repair conducted just prior to enrollment in the STEP-HI study) completed the DXA scan for BMD. A total of 9 EX+T, 6 EX+P, and 4 EUC participants were not scanned.
|
0.72 Grams/centimeters^2 (g/cm^2)
STANDARD_DEVIATION 0.12 • n=110 Participants • Only participants without hardware in their contralateral hip (opposite hip to the surgical repair conducted just prior to enrollment in the STEP-HI study) completed the DXA scan for BMD. A total of 9 EX+T, 6 EX+P, and 4 EUC participants were not scanned.
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS®) Global Health
Mental Health T-score
|
51.75 T-score
STANDARD_DEVIATION 6.20 • n=55 Participants
|
51.07 T-score
STANDARD_DEVIATION 6.39 • n=54 Participants
|
47.75 T-score
STANDARD_DEVIATION 7.99 • n=20 Participants
|
50.84 T-score
STANDARD_DEVIATION 6.67 • n=129 Participants
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS®) Global Health
Physical Health T-score
|
48.29 T-score
STANDARD_DEVIATION 6.35 • n=55 Participants
|
46.21 T-score
STANDARD_DEVIATION 6.51 • n=54 Participants
|
45.59 T-score
STANDARD_DEVIATION 5.99 • n=20 Participants
|
47.00 T-score
STANDARD_DEVIATION 6.42 • n=129 Participants
|
|
Serum Testosterone Level (Total)
|
15.67 nanograms per deciliter (ng/dL)
STANDARD_DEVIATION 9.19 • n=55 Participants
|
17.24 nanograms per deciliter (ng/dL)
STANDARD_DEVIATION 12.50 • n=54 Participants
|
13.02 nanograms per deciliter (ng/dL)
STANDARD_DEVIATION 5.85 • n=20 Participants
|
15.92 nanograms per deciliter (ng/dL)
STANDARD_DEVIATION 10.37 • n=129 Participants
|
|
Serum Testosterone Level (Free)
|
0.24 nanograms per deciliter (ng/dL)
STANDARD_DEVIATION 0.18 • n=37 Participants • The central lab was unable to process free testosterone for certain periods due to equipment failure. The measurement was obtained if possible.
|
0.25 nanograms per deciliter (ng/dL)
STANDARD_DEVIATION 0.14 • n=32 Participants • The central lab was unable to process free testosterone for certain periods due to equipment failure. The measurement was obtained if possible.
|
0.17 nanograms per deciliter (ng/dL)
STANDARD_DEVIATION 0.09 • n=17 Participants • The central lab was unable to process free testosterone for certain periods due to equipment failure. The measurement was obtained if possible.
|
0.22 nanograms per deciliter (ng/dL)
STANDARD_DEVIATION 0.15 • n=86 Participants • The central lab was unable to process free testosterone for certain periods due to equipment failure. The measurement was obtained if possible.
|
|
Hand grip strength - left hand
|
15.27 Kilograms (kg)
STANDARD_DEVIATION 6.04 • n=54 Participants • One participant was unable to preform the hand grip in the left hand.
|
15.96 Kilograms (kg)
STANDARD_DEVIATION 5.49 • n=54 Participants • One participant was unable to preform the hand grip in the left hand.
|
15.82 Kilograms (kg)
STANDARD_DEVIATION 5.45 • n=20 Participants • One participant was unable to preform the hand grip in the left hand.
|
15.65 Kilograms (kg)
STANDARD_DEVIATION 5.68 • n=128 Participants • One participant was unable to preform the hand grip in the left hand.
|
|
Hand grip strength - right hand
|
16.45 Kilograms (kg)
STANDARD_DEVIATION 5.84 • n=55 Participants
|
17.44 Kilograms (kg)
STANDARD_DEVIATION 5.95 • n=54 Participants
|
16.95 Kilograms (kg)
STANDARD_DEVIATION 5.69 • n=20 Participants
|
16.95 Kilograms (kg)
STANDARD_DEVIATION 5.84 • n=129 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsPopulation: Randomized participants (N=122) who completed the primary outcome measure at baseline and one other follow-up time point (3 Months or 6 Months post randomization).
Walking endurance was measured using a 6-Minute Walk Distance. Participants were asked to walk back and forth on a measured path marked clearly at both ends for turning purposes, while being told when each minute has passed, and receiving verbal encouragement every 60 seconds. Total distance was measured in meters with higher distances equating to higher walking endurance. Each individual participant distance from Baseline was subtracted from Month 6 to represent change over the length of the study. Higher positive values represent more improvement in walking distance. In addition to the primary analysis (unadjusted baseline to 6 month comparison), statistical contracts were evaluated to determine if there was significant between-group differences in the change from baseline to 3 months and additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline.
Outcome measures
| Measure |
Exercise + Testosterone (EX + T)
n=53 Participants
Supervised exercise training 2 times per week and topical testosterone 1% gel (12.5 mg per pump depression), both for six months duration.
Testosterone: Topical testosterone gel 1%
Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training
|
Exercise + Placebo (EX + P)
n=51 Participants
Supervised exercise training 2 times per week and placebo gel daily, both for six months duration.
Placebo gel: Inactive skin gel
Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training
|
Enhanced Usual Care (EUC)
n=18 Participants
Home exercise program 3 times per week and monthly health education modules, both for six months duration.
Home exercise program: Flexibility exercises performed at home 3 times per week and reviewed by study staff once a month.
Health Education Modules: 30-40 minute presentations conducted by study staff for participants focused on health concerns unrelated to exercise.
|
|---|---|---|---|
|
Change in Six Minute Walk Distance
Unadjusted baseline to 6 months
|
42.69 Meters
Interval 26.35 to 59.04
|
40.50 Meters
Interval 23.82 to 57.18
|
37.65 Meters
Interval 8.29 to 67.02
|
|
Change in Six Minute Walk Distance
Unadjusted baseline to 3 months
|
24.10 Meters
Interval 9.72 to 38.48
|
29.18 Meters
Interval 14.37 to 43.99
|
37.60 Meters
Interval 12.0 to 63.2
|
|
Change in Six Minute Walk Distance
Baseline to 6 month with covariates
|
42.38 Meters
Interval 24.96 to 59.8
|
41.75 Meters
Interval 23.98 to 59.52
|
33.95 Meters
Interval 4.3 to 63.6
|
|
Change in Six Minute Walk Distance
Baseline to 3 months with covariates
|
24.72 Meters
Interval 11.87 to 37.56
|
30.23 Meters
Interval 16.98 to 43.48
|
38.36 Meters
Interval 15.76 to 60.96
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Randomized participants (N=122) who completed the primary outcome measure at baseline and one other follow-up time point (3 Months or 6 Months post randomization).
Total lean body mass measured by dual x-ray absorptiometry (DXA). Baseline DXA scans were completed prior to the first administration of study drug. All scans were completed prior to exercise or 1-RM measurements if scheduled for the same day. DXA scans were reviewed for quality control, proper positioning, and artifacts centrally. Each individual participant measure from Baseline was subtracted from Month 6 to represent change over the length of the study. Higher positive values represent more gains in total lean body mass. Per the protocol: In addition to the primary analysis (unadjusted baseline to 6 month comparison), additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline. DXA was not performed at 3 months.
Outcome measures
| Measure |
Exercise + Testosterone (EX + T)
n=53 Participants
Supervised exercise training 2 times per week and topical testosterone 1% gel (12.5 mg per pump depression), both for six months duration.
Testosterone: Topical testosterone gel 1%
Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training
|
Exercise + Placebo (EX + P)
n=51 Participants
Supervised exercise training 2 times per week and placebo gel daily, both for six months duration.
Placebo gel: Inactive skin gel
Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training
|
Enhanced Usual Care (EUC)
n=18 Participants
Home exercise program 3 times per week and monthly health education modules, both for six months duration.
Home exercise program: Flexibility exercises performed at home 3 times per week and reviewed by study staff once a month.
Health Education Modules: 30-40 minute presentations conducted by study staff for participants focused on health concerns unrelated to exercise.
|
|---|---|---|---|
|
Change in Total Lean Body Mass
Unadjusted baseline to 6 month
|
922.91 grams
Interval 414.98 to 1430.83
|
565.19 grams
Interval 36.04 to 1094.33
|
-14.02 grams
Interval -972.19 to 944.14
|
|
Change in Total Lean Body Mass
Baseline to 6 month with covariates
|
930.80 grams
Interval 480.76 to 1380.83
|
547.43 grams
Interval 79.29 to 1015.57
|
94.16 grams
Interval -689.19 to 877.5
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Randomized participants (N=122) who completed the primary outcome measure at baseline and one other follow-up time point (3 Months or 6 Months post randomization).
Lean body mass of the arms and legs, measured by dual x-ray absorptiometry (DXA). Baseline DXA scans were completed prior to the first administration of study drug. All scans were completed prior to exercise or 1-RM measurements if scheduled for the same day. DXA scans were reviewed for quality control, proper positioning, and artifacts centrally. Each individual participant measure from Baseline was subtracted from Month 6 to represent change over the length of the study. Higher positive values represent more gains in appendicular lean body mass. Per the protocol: In addition to the primary analysis (unadjusted baseline to 6 month comparison), additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline. DXA was not performed at 3 months.
Outcome measures
| Measure |
Exercise + Testosterone (EX + T)
n=53 Participants
Supervised exercise training 2 times per week and topical testosterone 1% gel (12.5 mg per pump depression), both for six months duration.
Testosterone: Topical testosterone gel 1%
Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training
|
Exercise + Placebo (EX + P)
n=51 Participants
Supervised exercise training 2 times per week and placebo gel daily, both for six months duration.
Placebo gel: Inactive skin gel
Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training
|
Enhanced Usual Care (EUC)
n=18 Participants
Home exercise program 3 times per week and monthly health education modules, both for six months duration.
Home exercise program: Flexibility exercises performed at home 3 times per week and reviewed by study staff once a month.
Health Education Modules: 30-40 minute presentations conducted by study staff for participants focused on health concerns unrelated to exercise.
|
|---|---|---|---|
|
Change in Appendicular Lean Body Mass
Unadjusted baseline to 6 month
|
446.35 grams
Interval 163.2 to 729.49
|
429.19 grams
Interval 134.19 to 724.2
|
-116.29 grams
Interval -650.56 to 417.97
|
|
Change in Appendicular Lean Body Mass
Baseline to 6 month with covariates
|
453.30 grams
Interval 176.93 to 729.66
|
419.57 grams
Interval 131.61 to 707.53
|
-212.45 grams
Interval -699.35 to 274.44
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Randomized participants (N=122) who completed the primary outcome measure at baseline and one other follow-up time point (3 Months or 6 Months post randomization).
Muscle strength measured as the maximal amount of weight that the participant was able to lift for one repetition (1-RM). The 1-RM is defined as the greatest resistance that could be overcome through a defined range of motion using proper techniques. Subjects were asked to move against progressively heavier resistance loads until a repetition failure was achieved. Each individual participant measure from Baseline was subtracted from Month 6 to represent change over the length of the study. Higher positive values represent the increased ability to lift more weight. Per the protocol: In addition to the primary analysis (unadjusted baseline to 6 month comparison), statistical contracts were evaluated to determine if there was significant between-group differences in the change from baseline to 3 months and additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline.
Outcome measures
| Measure |
Exercise + Testosterone (EX + T)
n=53 Participants
Supervised exercise training 2 times per week and topical testosterone 1% gel (12.5 mg per pump depression), both for six months duration.
Testosterone: Topical testosterone gel 1%
Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training
|
Exercise + Placebo (EX + P)
n=51 Participants
Supervised exercise training 2 times per week and placebo gel daily, both for six months duration.
Placebo gel: Inactive skin gel
Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training
|
Enhanced Usual Care (EUC)
n=18 Participants
Home exercise program 3 times per week and monthly health education modules, both for six months duration.
Home exercise program: Flexibility exercises performed at home 3 times per week and reviewed by study staff once a month.
Health Education Modules: 30-40 minute presentations conducted by study staff for participants focused on health concerns unrelated to exercise.
|
|---|---|---|---|
|
Change in 1-repetition Maximum (1-RM) Leg Press Strength
Baseline to 6 month with covarites
|
64.26 pounds
Interval 50.78 to 77.74
|
59.45 pounds
Interval 45.37 to 73.54
|
39.36 pounds
Interval 15.86 to 62.85
|
|
Change in 1-repetition Maximum (1-RM) Leg Press Strength
Unadjusted baseline to 3 month
|
38.71 pounds
Interval 28.81 to 48.6
|
40.09 pounds
Interval 29.73 to 50.45
|
23.23 pounds
Interval 5.5 to 40.96
|
|
Change in 1-repetition Maximum (1-RM) Leg Press Strength
Baseline to 3 month with covariates
|
39.01 pounds
Interval 29.77 to 48.25
|
39.25 pounds
Interval 29.54 to 48.95
|
24.52 pounds
Interval 7.87 to 41.17
|
|
Change in 1-repetition Maximum (1-RM) Leg Press Strength
Unadjusted baseline to 6 month
|
62.62 pounds
Interval 48.5 to 76.73
|
61.91 pounds
Interval 47.32 to 76.51
|
38.18 pounds
Interval 13.2 to 63.16
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Randomized participants (N=122) who completed the primary outcome measure at baseline and one other follow-up time point (3 Months or 6 Months post randomization).
A modified version of the Physical Performance Test (mPPT) was used to measure physical function. Participants were asked to complete 9 standardized tasks (book lift, putting on a lab coat, picking up a penny from the floor, standing balance, standing up five times from a 16-inch chair, 50 foot walk including a turn, 360 degree turn, stair climb for 10 steps, and climbing 2 additional flights of steps) for a total score ranging from 0 (significant impairment) to 36 (excellent functioning). Each individual participant score from Baseline was subtracted from Month 6 to represent change over the length of the study. Higher positive values represent more improvement in physical functioning.
Outcome measures
| Measure |
Exercise + Testosterone (EX + T)
n=53 Participants
Supervised exercise training 2 times per week and topical testosterone 1% gel (12.5 mg per pump depression), both for six months duration.
Testosterone: Topical testosterone gel 1%
Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training
|
Exercise + Placebo (EX + P)
n=51 Participants
Supervised exercise training 2 times per week and placebo gel daily, both for six months duration.
Placebo gel: Inactive skin gel
Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training
|
Enhanced Usual Care (EUC)
n=18 Participants
Home exercise program 3 times per week and monthly health education modules, both for six months duration.
Home exercise program: Flexibility exercises performed at home 3 times per week and reviewed by study staff once a month.
Health Education Modules: 30-40 minute presentations conducted by study staff for participants focused on health concerns unrelated to exercise.
|
|---|---|---|---|
|
Change in Total Modified Physical Performance Test (mPPT) Score
Unadjusted baseline to 3 month
|
2.60 units on a scale
Interval 1.55 to 3.64
|
1.12 units on a scale
Interval 0.04 to 2.19
|
2.26 units on a scale
Interval 0.4 to 4.11
|
|
Change in Total Modified Physical Performance Test (mPPT) Score
Baseline to 3 month with covariates
|
2.61 units on a scale
Interval 1.69 to 3.54
|
1.15 units on a scale
Interval 0.2 to 2.11
|
2.31 units on a scale
Interval 0.7 to 3.93
|
|
Change in Total Modified Physical Performance Test (mPPT) Score
Unadjusted baseline to 6 month
|
3.32 units on a scale
Interval 2.24 to 4.41
|
2.12 units on a scale
Interval 1.01 to 3.22
|
2.97 units on a scale
Interval 1.0 to 4.95
|
|
Change in Total Modified Physical Performance Test (mPPT) Score
baseline to 6 month with covariates
|
3.33 units on a scale
Interval 2.03 to 4.64
|
2.20 units on a scale
Interval 0.87 to 3.52
|
2.74 units on a scale
Interval 0.53 to 4.95
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Randomized participants (N=122) who completed the primary outcome measure at baseline and one other follow-up time point (3 Months or 6 Months post randomization).
The Short Physical Performance Battery (SPPB) is a well validated objective physical performance measure used to identify risk for disability. The SPPB consists of: chair rise, progressive Romberg balance, and 4 meter gait speed. Each task was scored (0-4) with a total range of 0-12. Participants who score 0 are unable to complete the tasks and participants with higher scores are considered to have higher functional mobility. Each individual participant score from Baseline was subtracted from Month 6 to represent change over the length of the study. Higher positive values represent more improvement in physical performance. In addition to the primary analysis (unadjusted baseline to 6 month comparison), statistical contracts were evaluated to determine if there was significant between-group differences in the change from baseline to 3 months and additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline.
Outcome measures
| Measure |
Exercise + Testosterone (EX + T)
n=53 Participants
Supervised exercise training 2 times per week and topical testosterone 1% gel (12.5 mg per pump depression), both for six months duration.
Testosterone: Topical testosterone gel 1%
Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training
|
Exercise + Placebo (EX + P)
n=51 Participants
Supervised exercise training 2 times per week and placebo gel daily, both for six months duration.
Placebo gel: Inactive skin gel
Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training
|
Enhanced Usual Care (EUC)
n=18 Participants
Home exercise program 3 times per week and monthly health education modules, both for six months duration.
Home exercise program: Flexibility exercises performed at home 3 times per week and reviewed by study staff once a month.
Health Education Modules: 30-40 minute presentations conducted by study staff for participants focused on health concerns unrelated to exercise.
|
|---|---|---|---|
|
Change in Short Physical Performance Battery (SPPB) Score
Baseline to 6 month with covariates
|
1.55 units on a scale
Interval 1.12 to 1.99
|
0.73 units on a scale
Interval 0.29 to 1.17
|
1.43 units on a scale
Interval 0.65 to 2.21
|
|
Change in Short Physical Performance Battery (SPPB) Score
Unadjusted baseline to 6 month
|
1.53 units on a scale
Interval 1.11 to 1.96
|
0.68 units on a scale
Interval 0.25 to 1.11
|
1.45 units on a scale
Interval 0.67 to 2.24
|
|
Change in Short Physical Performance Battery (SPPB) Score
Unadjusted baseline to 3 month
|
1.02 units on a scale
Interval 0.59 to 1.45
|
0.32 units on a scale
Interval -0.12 to 0.77
|
1.11 units on a scale
Interval 0.35 to 1.88
|
|
Change in Short Physical Performance Battery (SPPB) Score
Baseline to 3 month with covariates
|
1.03 units on a scale
Interval 0.66 to 1.4
|
0.35 units on a scale
Interval -0.03 to 0.74
|
1.11 units on a scale
Interval 0.44 to 1.77
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Randomized participants (N=122) who completed the primary outcome measure at baseline and one other follow-up time point (3 Months or 6 Months post randomization).
The OARS Multidimensional Functional Assessment Questionnaire Activities of Daily Living (ADL) is a standardized, valid and reliable, self-report questionnaire used to determine the effect of services on the functional status of older adults by asking respondents about their ability to perform ADLS on 2 subscales: Basic (BADL) and Instrumental (IADL). Both subscales are scored from 0 (significant impairment) to 14 (excellent functioning). The individual participant score from Baseline was subtracted from Month 6 to represent change over the length of the study. Higher positive values represent more improvement in functioning. In addition to the primary analysis (unadjusted baseline to 6 month comparison), statistical contracts were evaluated to determine if there was significant between-group differences in the change from baseline to 3 months and additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline.
Outcome measures
| Measure |
Exercise + Testosterone (EX + T)
n=53 Participants
Supervised exercise training 2 times per week and topical testosterone 1% gel (12.5 mg per pump depression), both for six months duration.
Testosterone: Topical testosterone gel 1%
Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training
|
Exercise + Placebo (EX + P)
n=51 Participants
Supervised exercise training 2 times per week and placebo gel daily, both for six months duration.
Placebo gel: Inactive skin gel
Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training
|
Enhanced Usual Care (EUC)
n=18 Participants
Home exercise program 3 times per week and monthly health education modules, both for six months duration.
Home exercise program: Flexibility exercises performed at home 3 times per week and reviewed by study staff once a month.
Health Education Modules: 30-40 minute presentations conducted by study staff for participants focused on health concerns unrelated to exercise.
|
|---|---|---|---|
|
Change in Older Adult Resources and Services (OARS) Activities of Daily Living (ADL) Questionnaire
BADL Unadjusted baseline to 6 month
|
0.60 units on a scale
Interval 0.25 to 0.94
|
0.35 units on a scale
Interval 0.0 to 0.71
|
0.79 units on a scale
Interval 0.2 to 1.37
|
|
Change in Older Adult Resources and Services (OARS) Activities of Daily Living (ADL) Questionnaire
BADL Baseline to 6 month with covariates
|
0.59 units on a scale
Interval 0.2 to 0.98
|
0.36 units on a scale
Interval -0.04 to 0.75
|
0.83 units on a scale
Interval 0.19 to 1.48
|
|
Change in Older Adult Resources and Services (OARS) Activities of Daily Living (ADL) Questionnaire
BADL Unadjusted baseline to 3 month
|
0.36 units on a scale
Interval 0.03 to 0.69
|
0.14 units on a scale
Interval -0.2 to 0.47
|
0.56 units on a scale
Interval -0.03 to 1.15
|
|
Change in Older Adult Resources and Services (OARS) Activities of Daily Living (ADL) Questionnaire
BADL Baseline to 3 month with covariates
|
0.36 units on a scale
Interval 0.04 to 0.68
|
0.14 units on a scale
Interval -0.19 to 0.47
|
0.59 units on a scale
Interval 0.02 to 1.16
|
|
Change in Older Adult Resources and Services (OARS) Activities of Daily Living (ADL) Questionnaire
IADL Unadjusted baseline to 6 month
|
0.39 units on a scale
Interval -0.05 to 0.82
|
0.51 units on a scale
Interval 0.07 to 0.94
|
0.81 units on a scale
Interval 0.08 to 1.54
|
|
Change in Older Adult Resources and Services (OARS) Activities of Daily Living (ADL) Questionnaire
IADL Baseline to 6 month with covariates
|
0.40 units on a scale
Interval -0.03 to 0.82
|
0.51 units on a scale
Interval 0.08 to 0.95
|
0.74 units on a scale
Interval 0.04 to 1.45
|
|
Change in Older Adult Resources and Services (OARS) Activities of Daily Living (ADL) Questionnaire
IADL Unadjusted baseline to 3 month
|
0.70 units on a scale
Interval 0.33 to 1.07
|
0.47 units on a scale
Interval 0.09 to 0.85
|
0.47 units on a scale
Interval -0.19 to 1.13
|
|
Change in Older Adult Resources and Services (OARS) Activities of Daily Living (ADL) Questionnaire
IADL Baseline to 3 month with covariates
|
0.70 units on a scale
Interval 0.34 to 1.05
|
0.47 units on a scale
Interval 0.11 to 0.83
|
0.51 units on a scale
Interval -0.12 to 1.14
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Randomized participants (N=122) who completed the primary outcome measure at baseline and one other follow-up time point (3 Months or 6 Months post randomization).
The Functional Status Questionnaire (FSQ) is a self-reported measure asking about the amount of difficulty a participant experienced when performing daily tasks in the previous 4 weeks. There are a total of 6 subscales, but only the basic ADL and Intermediate ADL were used in the STEP-HI study for a total of 9 items. Scores range from 0 (high amount of difficulty completing tasks) to 36 (no difficulty completing tasks). Per the protocol: In addition to the primary analysis (unadjusted baseline to 6 month comparison), statistical contracts were evaluated to determine if there was significant between-group differences in the change from baseline to 3 months and additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline.
Outcome measures
| Measure |
Exercise + Testosterone (EX + T)
n=53 Participants
Supervised exercise training 2 times per week and topical testosterone 1% gel (12.5 mg per pump depression), both for six months duration.
Testosterone: Topical testosterone gel 1%
Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training
|
Exercise + Placebo (EX + P)
n=51 Participants
Supervised exercise training 2 times per week and placebo gel daily, both for six months duration.
Placebo gel: Inactive skin gel
Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training
|
Enhanced Usual Care (EUC)
n=18 Participants
Home exercise program 3 times per week and monthly health education modules, both for six months duration.
Home exercise program: Flexibility exercises performed at home 3 times per week and reviewed by study staff once a month.
Health Education Modules: 30-40 minute presentations conducted by study staff for participants focused on health concerns unrelated to exercise.
|
|---|---|---|---|
|
Change in Functional Status Questionnaire (FSQ) Total Score
Unadjusted baseline to 6 month
|
2.04 units on a scale
Interval 0.75 to 3.33
|
1.55 units on a scale
Interval 0.24 to 2.49
|
3.00 units on a scale
Interval 0.84 to 5.16
|
|
Change in Functional Status Questionnaire (FSQ) Total Score
Baseline to 6 month with covariates
|
2.02 units on a scale
Interval 0.67 to 3.38
|
1.56 units on a scale
Interval 0.18 to 2.94
|
3.06 units on a scale
Interval 0.81 to 5.31
|
|
Change in Functional Status Questionnaire (FSQ) Total Score
Baseline to 3 month with covariates
|
1.83 units on a scale
Interval 0.73 to 2.93
|
1.35 units on a scale
Interval 0.24 to 2.47
|
1.99 units on a scale
Interval 0.06 to 3.92
|
|
Change in Functional Status Questionnaire (FSQ) Total Score
Unadjusted baseline to 3 month
|
1.83 units on a scale
Interval 0.72 to 2.94
|
1.35 units on a scale
Interval 0.22 to 2.49
|
1.95 units on a scale
Interval -0.02 to 3.92
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Randomized participants (N=122) who completed the primary outcome measure at baseline and one other follow-up time point (3 Months or 6 Months post randomization).
The Hip Rating Questionnaire (HRQ) Standardized is a 14-item scale with weighted questions regarding quality of life (pain level and ability to walk) and function (ability to use stairs, put on socks/shoes, use public transportation, bathe, shop, do housework, and get in and out of a chair/bed) related to the hip fracture event. The scale scores range from 16 to 100. Higher scores are associated with less pain, higher function, and better quality of life. Per the protocol: In addition to the primary analysis (unadjusted baseline to 6 month comparison), statistical contracts were evaluated to determine if there was significant between-group differences in the change from baseline to 3 months and additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline.
Outcome measures
| Measure |
Exercise + Testosterone (EX + T)
n=53 Participants
Supervised exercise training 2 times per week and topical testosterone 1% gel (12.5 mg per pump depression), both for six months duration.
Testosterone: Topical testosterone gel 1%
Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training
|
Exercise + Placebo (EX + P)
n=51 Participants
Supervised exercise training 2 times per week and placebo gel daily, both for six months duration.
Placebo gel: Inactive skin gel
Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training
|
Enhanced Usual Care (EUC)
n=18 Participants
Home exercise program 3 times per week and monthly health education modules, both for six months duration.
Home exercise program: Flexibility exercises performed at home 3 times per week and reviewed by study staff once a month.
Health Education Modules: 30-40 minute presentations conducted by study staff for participants focused on health concerns unrelated to exercise.
|
|---|---|---|---|
|
Change in Hip Rating Questionnaire Total Score
Unadjusted baseline to 6 month
|
8.51 units on a scale
Interval 5.62 to 11.41
|
7.55 units on a scale
Interval 4.58 to 10.53
|
6.01 units on a scale
Interval 1.07 to 10.94
|
|
Change in Hip Rating Questionnaire Total Score
Baseline to 6 month with covariates
|
8.48 units on a scale
Interval 5.59 to 11.37
|
7.61 units on a scale
Interval 4.64 to 10.57
|
6.01 units on a scale
Interval 1.08 to 10.94
|
|
Change in Hip Rating Questionnaire Total Score
Baseline to 3 month with covariates
|
6.52 units on a scale
Interval 3.65 to 9.39
|
5.98 units on a scale
Interval 3.05 to 8.9
|
4.63 units on a scale
Interval -0.48 to 9.74
|
|
Change in Hip Rating Questionnaire Total Score
Unadjusted baseline to 3 month
|
6.52 units on a scale
Interval 3.65 to 9.4
|
5.98 units on a scale
Interval 3.04 to 8.91
|
4.25 units on a scale
Interval -0.89 to 9.4
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Randomized participants (N=122) who completed the primary outcome measure at baseline and one other follow-up time point (3 Months or 6 Months post randomization).
Patient-Reported Outcomes Measurement Information System (PROMIS®) Global Health instrument is a 10 item self report questionnaire used to measure overall quality of life using 2 summary scores: Physical and Mental Health. Each summary score is standardized to the general population, with the average T-score for the US population being 50 and standard deviation of 10. Each individual participant T-score from Baseline was subtracted from Month 6 T-score to represent change over the length of the study. Higher scores represent larger increases in Physical and Mental Health. Per the protocol: In addition to the primary analysis (unadjusted baseline to 6 month comparison), statistical contracts were evaluated to determine if there was significant between-group differences in the change from baseline to 3 months and additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline.
Outcome measures
| Measure |
Exercise + Testosterone (EX + T)
n=53 Participants
Supervised exercise training 2 times per week and topical testosterone 1% gel (12.5 mg per pump depression), both for six months duration.
Testosterone: Topical testosterone gel 1%
Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training
|
Exercise + Placebo (EX + P)
n=51 Participants
Supervised exercise training 2 times per week and placebo gel daily, both for six months duration.
Placebo gel: Inactive skin gel
Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training
|
Enhanced Usual Care (EUC)
n=18 Participants
Home exercise program 3 times per week and monthly health education modules, both for six months duration.
Home exercise program: Flexibility exercises performed at home 3 times per week and reviewed by study staff once a month.
Health Education Modules: 30-40 minute presentations conducted by study staff for participants focused on health concerns unrelated to exercise.
|
|---|---|---|---|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health
Physical Health - Unadjusted baseline to 6 month
|
1.89 T-score
Interval 0.25 to 3.52
|
1.25 T-score
Interval -0.43 to 2.94
|
4.07 T-score
Interval 1.29 to 6.85
|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health
Physical Health - Baseline to 6 month with covariates
|
1.88 T-score
Interval 0.03 to 3.72
|
1.24 T-score
Interval -0.65 to 3.13
|
4.03 T-score
Interval 0.92 to 7.13
|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health
Physical Health - Unadjusted baseline to 3 month
|
2.61 T-score
Interval 1.01 to 4.22
|
1.09 T-score
Interval -0.54 to 2.73
|
1.17 T-score
Interval -1.72 to 4.06
|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health
Physical Health - Baseline to 3 month with covariates
|
2.61 T-score
Interval 1.0 to 4.23
|
1.09 T-score
Interval -0.55 to 2.74
|
1.26 T-score
Interval -1.6 to 4.12
|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health
Mental Health - Unadjusted baseline to 6 month
|
1.55 T-score
Interval -0.25 to 3.34
|
-0.76 T-score
Interval -2.61 to 1.08
|
1.58 T-score
Interval -1.39 to 4.56
|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health
Mental Health - Baseline to 6 month with covariates
|
1.47 T-score
Interval -0.22 to 3.16
|
-0.69 T-score
Interval -2.42 to 1.04
|
1.93 T-score
Interval -0.9 to 4.77
|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health
Mental Health - Unadjusted baseline to 3 month
|
1.59 T-score
Interval 0.09 to 3.08
|
0.01 T-score
Interval -1.53 to 1.55
|
2.19 T-score
Interval -0.46 to 4.84
|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health
Mental Health - Baseline to 3 month with covariates
|
1.59 T-score
Interval 0.12 to 3.05
|
0.00 T-score
Interval -1.51 to 1.5
|
2.28 T-score
Interval -0.32 to 4.88
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Randomized participants (N=122) who completed the primary outcome measure at baseline and one other follow-up time point (3 Months or 6 Months post randomization).
Bone mineral density (BMD) measured by dual x-ray absorptiometry (DXA) of the non-fractured proximal femur in participants without hardware in the contralateral hip. Baseline DXA scans were completed prior to the first administration of study drug. All scans were completed prior to exercise or 1-RM measurements if scheduled for the same day. DXA scans were reviewed for quality control, proper positioning, and artifacts centrally. Per the protocol: In addition to the primary analysis (unadjusted baseline to 6 month comparison), additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline. DXA was not performed at 3 months.
Outcome measures
| Measure |
Exercise + Testosterone (EX + T)
n=53 Participants
Supervised exercise training 2 times per week and topical testosterone 1% gel (12.5 mg per pump depression), both for six months duration.
Testosterone: Topical testosterone gel 1%
Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training
|
Exercise + Placebo (EX + P)
n=51 Participants
Supervised exercise training 2 times per week and placebo gel daily, both for six months duration.
Placebo gel: Inactive skin gel
Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training
|
Enhanced Usual Care (EUC)
n=18 Participants
Home exercise program 3 times per week and monthly health education modules, both for six months duration.
Home exercise program: Flexibility exercises performed at home 3 times per week and reviewed by study staff once a month.
Health Education Modules: 30-40 minute presentations conducted by study staff for participants focused on health concerns unrelated to exercise.
|
|---|---|---|---|
|
Change in Bone Mineral Density (BMD) of the Non-fractured Proximal Femur
Baseline to 6 month with covariates
|
-0.002 g/cm^2
Interval -0.009 to 0.006
|
0.001 g/cm^2
Interval -0.007 to 0.008
|
0.000 g/cm^2
Interval -0.013 to 0.014
|
|
Change in Bone Mineral Density (BMD) of the Non-fractured Proximal Femur
Unadjusted baseline to 6 month
|
-0.008 g/cm^2
Interval -0.054 to 0.038
|
-0.001 g/cm^2
Interval -0.047 to 0.046
|
-0.021 g/cm^2
Interval -0.104 to 0.062
|
Adverse Events
Exercise + Testosterone (EX + T)
Serious events: 7 serious events
Other events: 36 other events
Deaths: 1 deaths
Exercise + Placebo (EX + P)
Serious events: 3 serious events
Other events: 24 other events
Deaths: 0 deaths
Enhanced Usual Care (EUC)
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Exercise + Testosterone (EX + T)
n=54 participants at risk
Supervised exercise training 2 times per week and topical testosterone 1% gel (12.5 mg per pump depression), both for six months duration.
Testosterone: Topical testosterone gel 1%
Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training
|
Exercise + Placebo (EX + P)
n=55 participants at risk
Supervised exercise training 2 times per week and placebo gel daily, both for six months duration.
Placebo gel: Inactive skin gel
Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training
|
Enhanced Usual Care (EUC)
n=20 participants at risk
Home exercise program 3 times per week and monthly health education modules, both for six months duration.
Home exercise program: Flexibility exercises performed at home 3 times per week and reviewed by study staff once a month.
Health Education Modules: 30-40 minute presentations conducted by study staff for participants focused on health concerns unrelated to exercise.
|
|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/54 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/55 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
1.9%
1/54 • Number of events 1 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/55 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/20 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Gastrointestinal disorders
Ruptured diverticulum of colon
|
1.9%
1/54 • Number of events 1 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/55 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/20 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
General disorders
Chest pain
|
1.9%
1/54 • Number of events 1 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/55 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/20 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Renal and urinary disorders
Kidney fibrosis
|
1.9%
1/54 • Number of events 1 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/55 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/20 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
General disorders
Medical device complication
|
0.00%
0/54 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
1.8%
1/55 • Number of events 1 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/20 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.9%
1/54 • Number of events 1 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/55 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/20 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
1.9%
1/54 • Number of events 1 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/55 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/20 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
1.9%
1/54 • Number of events 1 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/55 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/20 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
1.9%
1/54 • Number of events 1 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/55 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/20 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Nervous system disorders
Transient ischemic attack
|
1.9%
1/54 • Number of events 1 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/55 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/20 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/54 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
1.8%
1/55 • Number of events 1 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/20 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.9%
1/54 • Number of events 1 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/55 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/20 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/54 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
1.8%
1/55 • Number of events 1 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/20 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/54 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
1.8%
1/55 • Number of events 1 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/20 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Infections and infestations
Sepsis
|
1.9%
1/54 • Number of events 1 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/55 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/20 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.9%
1/54 • Number of events 1 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/55 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/20 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Gastrointestinal disorders
Constipation
|
1.9%
1/54 • Number of events 1 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/55 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/20 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/54 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
1.8%
1/55 • Number of events 1 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/20 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Gastrointestinal disorders
Vomiting bile
|
1.9%
1/54 • Number of events 1 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/55 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/20 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
Other adverse events
| Measure |
Exercise + Testosterone (EX + T)
n=54 participants at risk
Supervised exercise training 2 times per week and topical testosterone 1% gel (12.5 mg per pump depression), both for six months duration.
Testosterone: Topical testosterone gel 1%
Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training
|
Exercise + Placebo (EX + P)
n=55 participants at risk
Supervised exercise training 2 times per week and placebo gel daily, both for six months duration.
Placebo gel: Inactive skin gel
Supervised exercise training: Multicomponent exercise program focused primarily on progressive resistance exercise training
|
Enhanced Usual Care (EUC)
n=20 participants at risk
Home exercise program 3 times per week and monthly health education modules, both for six months duration.
Home exercise program: Flexibility exercises performed at home 3 times per week and reviewed by study staff once a month.
Health Education Modules: 30-40 minute presentations conducted by study staff for participants focused on health concerns unrelated to exercise.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
9.3%
5/54 • Number of events 5 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
3.6%
2/55 • Number of events 3 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/20 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Gastrointestinal disorders
Nausea
|
9.3%
5/54 • Number of events 7 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
1.8%
1/55 • Number of events 2 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/20 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
General disorders
Edema
|
0.00%
0/54 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/55 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
General disorders
Edema peripheral
|
0.00%
0/54 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
1.8%
1/55 • Number of events 2 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/54 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/55 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/54 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
5.5%
3/55 • Number of events 3 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/20 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
3/54 • Number of events 3 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
5.5%
3/55 • Number of events 3 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Infections and infestations
Urinary tract infection
|
7.4%
4/54 • Number of events 4 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
7.3%
4/55 • Number of events 5 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/20 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Injury, poisoning and procedural complications
Contusion
|
13.0%
7/54 • Number of events 7 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
3.6%
2/55 • Number of events 3 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/20 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/54 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
1.8%
1/55 • Number of events 1 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Investigations
Blood Calcium increased
|
0.00%
0/54 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
1.8%
1/55 • Number of events 1 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Investigations
Blood pressure increased
|
5.6%
3/54 • Number of events 5 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
3.6%
2/55 • Number of events 3 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/20 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
9/54 • Number of events 10 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
5.5%
3/55 • Number of events 3 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.4%
4/54 • Number of events 5 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
3.6%
2/55 • Number of events 2 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/54 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/55 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/54 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/55 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/54 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
1.8%
1/55 • Number of events 1 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
7.4%
4/54 • Number of events 4 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
5.5%
3/55 • Number of events 3 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/20 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.9%
1/54 • Number of events 1 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/55 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
11.1%
6/54 • Number of events 6 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
1.8%
1/55 • Number of events 1 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/20 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.6%
3/54 • Number of events 3 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
5.5%
3/55 • Number of events 3 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/20 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.6%
3/54 • Number of events 3 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/55 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/20 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.6%
3/54 • Number of events 3 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
9.1%
5/55 • Number of events 8 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/20 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Nervous system disorders
Dizziness
|
7.4%
4/54 • Number of events 4 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
1.8%
1/55 • Number of events 1 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/20 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/54 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/55 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
1.9%
1/54 • Number of events 1 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
1.8%
1/55 • Number of events 1 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/54 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/55 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Vascular disorders
Hypertension
|
3.7%
2/54 • Number of events 2 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
5.5%
3/55 • Number of events 8 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/20 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
|
Vascular disorders
Hypotension
|
7.4%
4/54 • Number of events 6 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
1.8%
1/55 • Number of events 1 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
0.00%
0/20 • Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.
At each monthly visit, participants were asked specific questions to elicit adverse events. Participants were asked to keep a daily log of falls, illnesses, and doctor's appointments to assist with adverse events assessment and recollection. Safety labs were drawn at baseline, Month 3, and Month 6. Any spontaneous report or visualized incident was also reported.
|
Additional Information
Dr. Ellen F. Binder, Professor of Medicine and Occupational Therapy
Washington University in St. Louis School of Medicine
Phone: 314-286-2707
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place