Testosterone Therapy and Bone Quality in Men With Diabetes and Hypogonadism
Completed · Phase 4 · Has a placebo group
Conditions studied: Type 2 Diabetes Mellitus, Hypogonadism
In brief
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 facts
- Study ID
- NCT03887936
- Run by
- VA Office of Research and Development
- People needed
- 92
- Starts
- 2019-10-01
- Expected to finish
- 2025-10-08
- Last updated by the study team
- 2026-04-29
Who can join
Age: 35 and older, up to 70. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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:
Where it is running
- Michael E. DeBakey VA Medical Center, Houston, TX — Houston, Texas, United States
Full record on ClinicalTrials.gov
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