Starting a Testosterone and Exercise Program After Hip Injury

Phase 3 Completed 129 enrolled Washington University School of Medicine Harvard University · collab Johns Hopkins University · collab The University of Texas Medical Branch, Galveston · collab University of Colorado, Denver · collab University of Connecticut · collab University of Maryland, Baltimore · collab University of Pittsburgh Medical Center · collab University of Utah · collab

RandomizedParallel-groupQuadruple-blindTreatment

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

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Testosterone	Small molecule	12.5 mg	Topical

Starting a Testosterone and Exercise Program After Hip Injury

Summary

Timeline

Publications

Drugs

Indications