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Testosterone Therapy and Bone Quality in Men With Diabetes and Hypogonadism

NCT03887936 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2026-04-29

Study results available
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Summary

Low testosterone and diabetes mellitus are each associated with increased risk for fractures. Men with diabetes mellitus are commonly found to have low testosterone as well. Testosterone has been shown to improve the bone health of patients with low testosterone but has not been tested in patients who also have diabetes mellitus in addition to low testosterone. To date, there is no treatment that is specifically recommended for bone disease among patients with diabetes. This study will evaluate the effect of testosterone on the bone health of male Veterans who have both diabetes and low testosterone, both of which are highly prevalent in this subset of the population.

Conditions

Interventions

DRUG

Testosterone gel 1.62%

Testosterone gel 1.62%, apply 2 pumps to upper arm and shoulder.

DRUG

Placebo

Matching placebo gel, apply 2 pumps to upper arm and shoulder

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Reina C. Villareal, MD · Michael E. DeBakey VA Medical Center, Houston, TX

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2025-10-08
Completion
2025-10-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03887936 on ClinicalTrials.gov