Can testosterone fix fragile bones in diabetic men?
NCT ID NCT03887936
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether testosterone therapy can improve bone health in men who have both type 2 diabetes and low testosterone. About 92 male veterans aged 35 to 70 took part. Researchers measured bone strength using special scans and blood tests over 12 months to see if testosterone helps prevent fractures.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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92 people
The number who actually took part.
- Started
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Oct 2019
- Finished
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Oct 2025
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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35 to 70 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030-4211, United States
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Other studies related to the condition(s) this trial covers.
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