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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

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 Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 6 months

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

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

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Harvard UniversityOTHER

229 Previous Clinical Trials

474,454 Total Patients Enrolled

University of ConnecticutOTHER

181 Previous Clinical Trials

157,916 Total Patients Enrolled

The University of Texas Medical Branch, GalvestonOTHER

241 Previous Clinical Trials

56,469 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

Recent research and studies

clinicaltrials.govStudy

Starting a Testosterone and Exercise Program After Hip Injury

Ellen F. Binder, MD 2019. "Starting a Testosterone and Exercise Program After Hip Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02938923.