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Testosterone for Hip Fracture (STEP-HI Trial)

Phase 3
Waitlist Available
Led By Ellen F Binder, MD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 6 months
Awards & highlights

Summary

This trial is testing whether combining testosterone gel with exercise can help hip fracture patients 65 and older heal better than exercise alone.

Eligible Conditions
  • Hip Fracture
  • Frailty
  • Sarcopenia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in six minute walk distance at 6 months
Secondary outcome measures
Leg
Change in Appendicular Lean Body Mass at 6 months
Change in Bone Mineral Density (BMD) of the non-fractured proximal femur at 6 months
+7 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Exercise + Testosterone (EX + T)Experimental Treatment2 Interventions
Supervised exercise training 2 times per week and topical testosterone 1% gel (12.5 mg per pump depression) daily, both for six months duration.
Group II: Enhanced Usual Care (EUC)Experimental Treatment2 Interventions
Home exercise program 3 times per week and monthly health education modules, both for six months duration.
Group III: Exercise + Placebo (EX + P)Placebo Group2 Interventions
Supervised exercise training 2 times per week and placebo gel daily, both for six months duration.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Home exercise program
2017
Completed Phase 3
~870
Health Education Modules
2019
Completed Phase 3
~130
Testosterone
2009
Completed Phase 4
~2020
Supervised exercise training
2010
Completed Phase 3
~350

Find a Location

Who is running the clinical trial?

Harvard UniversityOTHER
232 Previous Clinical Trials
474,966 Total Patients Enrolled
University of ConnecticutOTHER
186 Previous Clinical Trials
160,132 Total Patients Enrolled
The University of Texas Medical Branch, GalvestonOTHER
246 Previous Clinical Trials
56,671 Total Patients Enrolled
~20 spots leftby Jul 2025
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