Starting a Testosterone and Exercise Program After Hip Injury

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.

Conditions

• Hip Fracture
• Frailty
• Sarcopenia

Interventions

DRUG

Testosterone

Topical testosterone gel 1%

DRUG

Placebo gel

Inactive skin gel

BEHAVIORAL

Supervised exercise training

Multicomponent exercise program focused primarily on progressive resistance exercise training

BEHAVIORAL

Home exercise program

Flexibility exercises performed at home 3 times per week and reviewed by study staff once a month.

BEHAVIORAL

Health Education Modules

30-40 minute presentations conducted by study staff for participants focused on health concerns unrelated to exercise.

Sponsors & Collaborators

• University of Maryland, Baltimore

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• The University of Texas Medical Branch, Galveston

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• Harvard University

  collaborator OTHER

• University of Connecticut

  collaborator OTHER

• University of Utah

  collaborator OTHER

• University of Pittsburgh Medical Center

  collaborator OTHER

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• Ellen F Binder, MD · Washington University School of Medicine

• Kenneth B Schechtman, PhD · Washington University School of Medicine

• Jay Magaziner, PhD · University of Maryland, Baltimore

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-05

Primary Completion

2023-08-31

Completion

2023-11-06

FDA Drug

Yes

Countries

• United States

Study Locations