NCT03887936CompletedPhase 4
Testosterone Therapy and Bone Quality in Men With Diabetes and Hypogonadism
Source: ClinicalTrials.gov · Last updated 29 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 92 (actual)
- First submitted
- 21 Mar 2019
- Start date
- 1 Oct 2019
- Primary completion date
- 8 Oct 2025
- Lead sponsor
- VA Office of Research and Development
- Diseases
- Type 2 diabetes
- NCT number
- NCT03887936
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 92
- From 1 Oct 2019 to the primary completion date, 8 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- history of prostate or breast cancer
- history of testicular disease
- ongoing illness that could prevent the subject from completing the study
- 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
- 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
Lab values
- serum PSA of 4.0 ng/ml
Other
- untreated severe sleep apnea
- a hematocrit of \>50%
- prostate-related findings as:
- a palpable prostate nodule on digital rectal exam (DRE)
- International Prostate Symptom Score (IPSS) \>19 (severe)
- use of bisphosphonates within two years of study entry, i.e.:
- risedronate
- alendronate
- zoledronic acid
- pamidronate
- current alcohol use of \> 3 drinks/day
Who the study is looking for
- 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
Age in the registry: 35 years to 70 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Michael E. DeBakey VA Medical Center, Houston, TX Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.