| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02938923 | Starting a Testosterone and Exercise Program After Hip Injury | PHASE3 | COMPLETED | 129 | — | — | Mar 5, 2019 | Nov 6, 2023 | Feb 4, 2025 | 8 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| Exercise + Testosterone (EX + T) | EXPERIMENTAL | Supervised exercise training 2 times per week and topical testosterone 1% gel (12.5 mg per pump depression) daily, both for six months duration. |
| Exercise + Placebo (EX + P) | PLACEBO_COMPARATOR | Supervised exercise training 2 times per week and placebo gel daily, both for six months duration. |
| Enhanced Usual Care (EUC) | OTHER | Home exercise program 3 times per week and monthly health education modules, both for six months duration. |
| Name | Type | Description |
|---|---|---|
| Testosterone | DRUG | Topical testosterone gel 1% |
| Placebo gel | DRUG | Inactive skin gel |
| Supervised exercise training | BEHAVIORAL | Multicomponent exercise program focused primarily on progressive resistance exercise training |
| Home exercise program | BEHAVIORAL | Flexibility exercises performed at home 3 times per week and reviewed by study staff once a month. |
| Health Education Modules | BEHAVIORAL | 30-40 minute presentations conducted by study staff for participants focused on health concerns unrelated to exercise. |
Inclusion Criteria: * Female 65 years and older. * Surgical repair of a non-pathologic fracture of the proximal femur (Including: femoral neck or intracapsular, intertrochanteric, and subtrochanteric fractures) with a surgical repair date that is within 24 weeks at randomization. If a revision of s...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Zimmer Biomet Holdings, Inc. | ZBH | 23 | NA | Undisclosed |
| Stryker Corporation | SYK | 4 | — | Undisclosed |
| Johnson & Johnson | JNJ | 1 | NA | Undisclosed |
| Orthofix Medical, Inc. | OFIX | 1 | — | Undisclosed |
| Cooper Companies, Inc. | COO | 1 | — | Undisclosed |