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Beyond T-Trials, T4DM and TRAVERSE: the next large testosterone randomized controlled trial
Bu B Yeap1,2, Cammie Tran3, Catherine M Douglass4
1Medical School, University of Western Australia.
Current Opinion in Endocrinology, Diabetes, and Obesity
|September 18, 2024
Summary
Lower testosterone levels in aging men are linked to adverse health outcomes. Recent trials show testosterone therapy can benefit diabetes and sexual function but requires careful consideration for broader use, especially regarding bone fractures.
Area of Science:
- Endocrinology
- Geriatrics
- Cardiovascular Medicine
Background:
- Aging men often experience declining testosterone levels, associated with negative health outcomes.
- Establishing causality and therapeutic benefits necessitates rigorous randomized clinical trials (RCTs).
Purpose of the Study:
- To review recent observational data and major testosterone RCTs.
- To evaluate the need for further large-scale testosterone trials in aging men.
Main Methods:
- Analysis of recent observational studies on testosterone and health.
- Review of key testosterone randomized clinical trials, including T4DM and TRAVERSE.
- Consideration of individual participant data meta-analysis findings.
Main Results:
- Testosterone decline is linked to increased risks of diabetes, dementia, and mortality.
- Testosterone treatment (T4DM) prevented/reversed type 2 diabetes and improved sexual function and bone density.
- Cardiovascular and prostate safety were demonstrated (TRAVERSE), but increased clinical bone fractures were noted.
Conclusions:
- Testosterone therapy is warranted for men with diagnosed androgen deficiency (HPT axis disorders).
- Wider use for cardiometabolic disease prevention lacks sufficient RCT evidence.
- Further large RCTs are needed to explore testosterone's potential to extend disability-free survival in older men.
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