Combining Exercise Training and Testosterone Therapy in Older Women After Hip Fracture: The STEP-HI Randomized Clinical Trial
An erratum to this article was published (JAMA Netw Open, 2 Jun 2025 ↗)
Authors' conclusion
In the STEP-HI randomized clinical trial, supervised exercise training combined with testosterone therapy conducted in older women recovering from a hip fracture did not lead to significant improvement in 6MWD compared with supervised exercise alone.
Study context
- Population
- Community-dwelling women aged ≥65 years with recent surgical repair of a nonpathologic femur fracture and objective mobility impairment, after discharge from rehabilitation; 8 US sites, December 2018 to August 2023mean [SD] age 79.3 [8.4] years
- Participants
- 129 women
- Comparison
- Supervised exercise plus topical testosterone gel vs exercise plus placebo gel vs enhanced usual care
- Exercise plus testosteronen = 54
- Exercise plus placebon = 55reference
- Enhanced usual caren = 20
- Primary endpoint
- Between-group difference in change in 6-minute walking distance (6MWD) from baseline
- Follow-up
- 24 weeks
Methodological detailsphase 3, double-blind, placebo-controlled, multicentre (8 US sites), modified intention-to-treat
- Phase 3
- Double-blind
- Placebo-controlled
- Multicentre (8 US sites)
- Modified intention-to-treat
Primary result
As reported in the abstract
Change in 6MWD, baseline to 24 weeks
Exercise plus testosterone
42.7
mean · SD 8.2 · m
Exercise plus placebo
40.5
mean · SD 8.4 · m
Enhanced usual care
37.7
mean · SD 14.8 · m
Original publication
Combining Exercise Training and Testosterone Therapy in Older Women After Hip Fracture: The STEP-HI Randomized Clinical Trial. JAMA Netw Open. Published 1 May 2025. doi:10.
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