Testosterone Therapy and Bone Quality in Men With Diabetes and Hypogonadism

ENDB-009-18F

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.

2019-10-01

2024-09-30

2025-09-30

Recruiting

Early phase I

166

Inclusion Criteria: * Male veterans only * 35 to 65 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 \<10.5 % * a fasting blood sugar of 180 mg/dl * body mass index (BMI) \<35 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 * hypercortisolism * malabsorption * immobilization * current alcohol use of \> 3 drinks/day * those with a history of: * deep vein thrombosis * pulmonary embolism * stroke or recent diagnosis of coronary artery disease * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double-blind randomized placebo-controlled study comparing the effect of testosterone therapy in men with both type 2 diabetes mellitus and hypogonadism on bone quality, bone turnover markers and circulating osteoblast and osteoclast progenitors.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'No other parties will be masked.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 166, 'type': 'ESTIMATED'}}

2023-10-23