TRAVERSE (subtrial, fracture)
Trial question
What is the role of testosterone treatment in the prevention of fractures in men with hypogonadism?
Study design
Multi-center
Double blinded
RCT
Population
5204 male patients.
Inclusion criteria: men aged 45-80 years with hypogonadism.
Key exclusion criteria: congenital or acquired hypogonadism for whom long-term therapy with placebo would not be medically appropriate; PSA > 3.0 ng/mL; testosterone treatment in the past 6 months; contraindication to testosterone therapy.
Interventions
N=2601 testosterone (daily application of transdermal 1.62% gel).
N=2603 placebo (matching placebo gel daily).
Primary outcome
Clinical fracture
3.5%
2.46%
3.5 %
2.6 %
1.8 %
0.9 %
0.0 %
Testosterone
Placebo
Significant
increase ▲
NNH = 96
Significant increase in clinical fracture (3.5% vs. 2.46%; HR 1.43, 95% CI 1.04 to 1.97).
Secondary outcomes
No significant difference in non-high-impact clinical fractures (2.88% vs. 2.19%; HR 1.32, 95% CI 0.94 to 1.86).
Significant increase in clinical fractures in patients not taking osteoporosis medication (3.4% vs. 2.43%; HR 1.41, 95% CI 1.02 to 1.94).
No significant difference in fracture-free survival (8.69% vs. 7.61%; HR 1.15, 95% CI 0.95 to 1.39).
Safety outcomes
No significant difference in serious adverse events involving the musculoskeletal system.
Conclusion
In men aged 45-80 years with hypogonadism, testosterone was inferior to placebo with respect to clinical fracture.
Reference
Peter J Snyder, Douglas C Bauer, Susan S Ellenberg et al. Testosterone Treatment and Fractures in Men with Hypogonadism. N Engl J Med. 2024 Jan 18;390(3):203-211.
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