Phase 4
N=92
Testosterone Therapy and Bone Quality in Men With Diabetes and Hypogonadism
Type 2 Diabetes Mellitus · Hypogonadism
Bottom Line
View on ClinicalTrials.gov: NCT03887936 ↗Enrolled (actual)
92
Serious AEs
7.6%
Results posted
Dec 2025
Primary outcome: Primary: Finite Element Analysis of Bone to Measure Bone Strength — 1.2; 1.6; 1.6; 0.88 % change — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Testosterone gel 1.62% (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- Male
- Sponsor
- VA Office of Research and Development
- Primary completion
- Oct 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Finite Element Analysis of Bone to Measure Bone Strength |
1.2; 1.6; 1.6; 0.88; -0.50; -0.45 | <0.05 sig |
| SECONDARY Markers of Bone Turnover to Measure Bone Metabolism |
-9.7; 17.4; 7.8; 33.8; -81.6; -80.4 | — |
| SECONDARY Osteoblast and Osteoclast Progenitor Cells Which Are Cells Found in Bone |
5.1; -4.4; 10.8; -10.4; 68.4; 19.2 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Male veterans only
- 35 to 70 years old
- With an average fasting morning T level from 2 measurements 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 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
Data sourced from ClinicalTrials.gov (NCT03887936). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.