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ACTIVE NOT RECRUITING

NCT03887936

PHASE4

Testosterone Therapy and Bone Quality in Men With Diabetes and Hypogonadism

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

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.

Key Details

Gender

MALE

Age Range

35 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2019-10-01

Completion Date

2026-06-30

Last Updated

2025-12-23

Healthy Volunteers

Conditions

Type 2 Diabetes Mellitus Hypogonadism

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

Inclusion Criteria: * Male veterans only * 35 to 70 years old * With an average fasting morning T level from 2 measurements of \<300 ng/dl taken at least a day apart * symptoms of hypogonadism as assessed using the androgen deficiency in aging male (ADAM) questionnaire * Participants should have * T2D * an A1C of \<11.5 % * a fasting blood sugar of 180 mg/dl * body mass index (BMI) \<40 kg/m2 * with DM of 15 years duration or less to target men who have relatively less complications from long-term DM Exclusion Criteria: * history of prostate or breast cancer * history of testicular disease * untreated severe sleep apnea * ongoing illness that could prevent the subject from completing the study * a hematocrit of \>50% * prostate-related findings as: * a palpable prostate nodule on digital rectal exam (DRE) * serum PSA of 4.0 ng/ml * International Prostate Symptom Score (IPSS) \>19 (severe) * on androgen therapy or selective androgen receptor modulators * on medications that affect bone metabolism such as: * estrogen * selective estrogen receptor modulator as: * raloxifene * aromatase inhibitors * GnRH analogs * glucocorticoids with prednisone equivalent of least 5 mg daily for 1 month * anabolic steroids * phenobarbital and Dilantin * use of bisphosphonates within two years of study entry, i.e.: * risedronate * alendronate * zoledronic acid * pamidronate * diseases that interfere with bone metabolism, as: * hyperparathyroidism * untreated hyperthyroidism * osteomalacia * chronic liver disease * renal failure with estimated glomerular filtration rate of \<45 ml/min * hypercortisolism * malabsorption * immobilization * current alcohol use of \> 3 drinks/day * those with a history of: * deep vein thrombosis * pulmonary embolism * recent stroke or recent diagnosis of coronary artery disease of \< 6 months * because of the potential of being randomized to placebo, subjects with osteoporosis or a BMD T-score by DXA of -2.5 in the lumbar spine, total femur or femoral neck and those with a history of fragility fractures * spine * hip * wrist

Locations (1)

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, United States