Testosterone for Hip Fracture

University of Pittsburgh Medical Center, Pittsburgh, PA
Hip Fracture+12 More ConditionsTestosterone - Drug
Eligibility
65+
Female
What conditions do you have?
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Study 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
  • Frailty Syndrome
  • Debilitated States
  • Sarcopenia
  • Preoperative Frailty

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: Baseline and 6 months

Baseline and 6 months
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
Change in Functional Status Questionnaire (FSQ) Total Score at 6 months
Change in Hip Rating Questionnaire Total Score at 6 months
Change in Older Adult Resources and Services Activities of Daily Living (ADL) Questionnaire (OARS) ADL Total Score at 6 months
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health score at 6 months
Change in Short Physical Performance Battery (SPPB) Score at 6 months
Change in Total Lean Body Mass at 6 months
Change in Total Modified Physical Performance Test (mPPT) Score at 6 months
Change in six minute walk distance at 6 months

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2 Treatment Groups

Exercise + Testosterone (EX + T)
1 of 2
Exercise + Placebo (EX + P)
1 of 2

Experimental Treatment

Non-Treatment Group

129 Total Participants · 2 Treatment Groups

Primary Treatment: Testosterone · Has Placebo Group · Phase 3

Exercise + Testosterone (EX + T)Experimental Group · 2 Interventions: Testosterone, Supervised exercise training · Intervention Types: Drug, Behavioral
Exercise + Placebo (EX + P)PlaceboComparator Group · 2 Interventions: Placebo gel, Supervised exercise training · Intervention Types: Drug, Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Testosterone
FDA approved
Supervised exercise training
2010
Completed Phase 3
~220

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and 6 months

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,846 Previous Clinical Trials
2,280,444 Total Patients Enrolled
4 Trials studying Hip Fracture
85 Patients Enrolled for Hip Fracture
University of Maryland, BaltimoreOTHER
633 Previous Clinical Trials
357,256 Total Patients Enrolled
4 Trials studying Hip Fracture
640 Patients Enrolled for Hip Fracture
University of Colorado, DenverOTHER
1,639 Previous Clinical Trials
1,659,424 Total Patients Enrolled
The University of Texas Medical Branch, GalvestonOTHER
227 Previous Clinical Trials
54,829 Total Patients Enrolled
Johns Hopkins UniversityOTHER
2,115 Previous Clinical Trials
32,578,640 Total Patients Enrolled
Harvard UniversityOTHER
220 Previous Clinical Trials
18,230,775 Total Patients Enrolled
University of ConnecticutOTHER
167 Previous Clinical Trials
155,185 Total Patients Enrolled
University of UtahOTHER
1,022 Previous Clinical Trials
1,776,246 Total Patients Enrolled
2 Trials studying Hip Fracture
44 Patients Enrolled for Hip Fracture
University of Pittsburgh Medical CenterOTHER
57 Previous Clinical Trials
81,787 Total Patients Enrolled
Kenneth B Schechtman, PhDPrincipal InvestigatorWashington University School of Medicine
Ellen F Binder, MDPrincipal InvestigatorWashington University School of Medicine
Jay Magaziner, PhDPrincipal InvestigatorUniversity of Maryland, Baltimore

Eligibility Criteria

Age 65+ · Female Participants · 0 Total Inclusion Criteria

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Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.