
Use of topical testosterone therapy in addition to supervised exercise training does little to improve long-distance walking ability for older women recovering from a hip fracture, according to the phase III STEP-HI randomized clinical trial.
STEP-HI included 129 older women (mean age 79.3 years) who had undergone a recent surgical repair of a nonpathologic femur fracture, met objective criteria for mobility impairment, and were community dwelling after discharge from rehabilitation.
The women were randomly assigned to undergo exercise plus topical testosterone gel (n=54), exercise plus placebo gel (n=55), and enhanced usual care (n=20) for 24 weeks. Participants in the exercise groups underwent a multimodal high-intensity exercise program that included progressive resistance training with trained and certified exercise interventionists. Testosterone was formulated as a topical gel (generic 1.0% testosterone), while the placebo gel was chemically identical but without testosterone. The enhanced usual care group received a prescription for self-administered low-intensity home-based exercise program and attended a staff-led monthly health education session.
The primary outcome of change in the 6-minute walking distance (6MWD) from baseline to 24 weeks in the exercise plus topical testosterone gel group did not significantly differ than that observed in the exercise plus placebo gel group and the enhanced usual care group (42.7 vs 40.5 and 37.7 m, respectively).
More studies are needed to assess whether testosterone gel can improve physical performance and mobility for short distances in the patient population.