Starting a Testosterone and Exercise Program After Hip Injury
Summary
This study is a randomized controlled double-blinded multi-center clinical trial enrolling female hip fracture patients who are 65 and older. It will compare the effects of six months of supervised exercise training combined with daily topical testosterone gel, to six months of supervised exercise and inactive gel, and to Enhanced Usual Care. The randomization protocol is that for every nine participants randomized, 4 will be assigned to the topical testosterone gel and supervised exercise training group; 4 will be assigned to topical inactive gel and supervised exercise training group; and 1 will be assigned to the enhanced usual care group. All participants will receive nutritional counseling, and calcium and vitamin D supplements.
Timeline
- Start
- 2019-03-05
- Primary completion
- 2023-08-31
- Completion
- 2023-11-06
Outcome
Missed primary endpoint
registry Exercise + Testosterone (EX + T) vs Exercise + Placebo (EX + P); p = 0.853 NCT02938923 ↗
paper did not lead to significant improvement in 6MWD compared with supervised exercise alone. PMID 40372752 ↗
Publications
- Background Binder EF, Christensen JC, Stevens-Lapsley J, Bartley J, Berry SD, Dobs AS, Fortinsky RH, Hildreth KL, Kiel DP, Kuchel GA, Marcus RL, McDonough CM, Orwig D, Sinacore DR, Schwartz RS, Volpi E, Magaziner J, Schechtman KB. A multi-center trial of exercise and testosterone therapy in women after hip fracture: Design, methods and impact of the COVID-19 pandemic. Contemp Clin Trials. 2021 May;104:106356. doi: 10.1016/j.cct.2021.106356. Epub 2021 Mar 11.
- Earp JE, Zhao S, Xu F, Kuo CL, Bartley JM, Fortinsky RH, Kositsawat J, Rehbein CO, Binder EF, Stevens-Lapsley J, Kuchel GA. Testosterone therapy effects adipose distribution in older females post hip-fracture: The STEP-HI study. Obes Pillars. 2026 Jan 12;17:100247. doi: 10.1016/j.obpill.2026.100247. eCollection 2026 Mar.
- Binder EF, Bartley JM, Berry SD, Dore PM, Fisher SR, Fortinsky RH, Guild C, Kiel DP, Kuchel GA, Marcus RL, McDonough CM, Monroe KM, Orwig DL, Paluch RA, Reeds D, Stevens-Lapsley J, Volpi E, Schechtman KB, Magaziner JS. Combining Exercise Training and Testosterone Therapy in Older Women After Hip Fracture: The STEP-HI Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e2510512. doi: 10.1001/jamanetworkopen.2025.10512.
- Fairhall NJ, Dyer SM, Mak JC, Diong J, Kwok WS, Sherrington C. Interventions for improving mobility after hip fracture surgery in adults. Cochrane Database Syst Rev. 2022 Sep 7;9(9):CD001704. doi: 10.1002/14651858.CD001704.pub5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Testosterone | Small molecule | 12.5 mg | Topical |