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Phase 3CompletedHealthspan endpoint

Starting a Testosterone and Exercise Program After Hip Injury (STEP-HI)

Combining Testosterone Therapy and Exercise to Improve Function Post Hip Fracture

Sponsor
Washington University School of Medicine (Academic or other)
Enrollment
129 enrolled
Conditions
Hip Fracture; Frailty; Sarcopenia
Interventions
Testosterone; Placebo gel; Supervised exercise training; Home exercise program; Health Education Modules
Ages
older adults
Registry
NCT02938923

Full record on ClinicalTrials.gov

From the registry

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.

Primary outcomes

  • Change in Six Minute Walk Distance

History

  1. Results first posted

  2. Last registry update

  3. Study completion

  4. Primary completion

  5. Started

  6. Registered

Papers citing this trial