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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
Functional impairment at the time of screening, defined as a modified Physical Performance Score (mPPT) of 12-28
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 6 months
Awards & highlights
Pivotal Trial

STEP-HI Trial 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

STEP-HI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have difficulty performing everyday tasks and have a low score on a test that measures your physical abilities.

STEP-HI Trial 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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

STEP-HI 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
Testosterone
2009
Completed Phase 4
~2020
Supervised exercise training
2010
Completed Phase 3
~350
Home exercise program
2017
Completed Phase 3
~800
Health Education Modules
2017
Completed Phase 3
~130

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityOTHER
2,222 Previous Clinical Trials
14,811,374 Total Patients Enrolled
University of ConnecticutOTHER
179 Previous Clinical Trials
157,959 Total Patients Enrolled
Harvard UniversityOTHER
229 Previous Clinical Trials
475,523 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What does the FDA think of Supervised exercise training?

"Supervised exercise training has received a score of 3 from our team at Power. This is due to the fact that this is a Phase 3 trial, meaning there is some data supporting efficacy and multiple rounds of data supporting safety."

Answered by AI

Are there any spaces available for new participants in this research?

"That is correct, the listed clinical trial on clinicaltrials.gov is recruiting patients. This specific research project was originally posted on September 15th, 2017 and has been updated as recently as May 31st, 2022. The study requires 120 individuals total at 6 different locations."

Answered by AI

Where are patients able to participate in this trial?

"There are several places where patients can take part in this study, such as University of Connecticut Heath - UConn Health in Farmington, Connecticut; University of Pittsburgh Medical Center in Pittsburgh, Pennsylvania; or University of Utah in Salt Lake City, Utah."

Answered by AI

What condition does Supervised exercise training help improve the most?

"Although often used to treat hypogonadotropic hypogonadism, supervised exercise training is a versatile therapy that can be taken to address a variety of other issues like 1 to 5 years post-menopausal, orchidectomy, orchitis."

Answered by AI

Does this research paper's findings corroborate previous work on Supervised exercise training?

"As of right now, there are a total of 32 different clinical trials underway that are investigating the efficacy of Supervised Exercise Training. 5 of those trials are currently in Phase 3. The majority of studies for Supervised Exercise Training are based in Houston, Texas; however, there are a total of 158 locations across the globe running trials for this treatment."

Answered by AI

How many test subjects are included in this experiment?

"In total, this study needs 120 individuals that match the pre-determined inclusion criteria. There are multiple locations where patients can take part in the trial, such as University of Connecticut Heath - UConn Health in Farmington, Connecticut and University of Pittsburgh Medical Center in Pittsburgh, Pennsylvania."

Answered by AI
~17 spots leftby Feb 2025