At a glance
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Combining Testosterone Therapy and Exercise to Improve Function Post Hip Fracture
In Brief
A Phase 3 clinical trial evaluating Testosterone, Placebo gel, and 3 other interventions for Hip Fracture and 2 related conditions. Completed, enrolled 129 participants across 8 sites.
Detailed 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.
Study Details
Timeline
Interventions
Topical testosterone gel 1%
Inactive skin gel
Multicomponent exercise program focused primarily on progressive resistance exercise training
Flexibility exercises performed at home 3 times per week and reviewed by study staff once a month.
30-40 minute presentations conducted by study staff for participants focused on health concerns unrelated to exercise.