Testosterone Treatment and Fractures in Men with Hypogonadism
Primary result · Clinical fractureResult — go to the resultHazard ratio 1.43 95% CI 1.04–1.97Authors' conclusion
Among middle-aged and older men with hypogonadism, testosterone treatment did not result in a lower incidence of clinical fracture than placebo. The fracture incidence was numerically higher among men who received testosterone than among those who received placebo.
Study context
- Population
- Men 45 to 80 years with hypogonadism (≥1 symptom; two morning testosterone <300 ng per deciliter) and preexisting, or high risk of, CVDfull-analysis population
- Participants
- 5,204 men
- Comparison
- Daily testosterone gel vs placebo gel
- Testosteronen = 2,601
- Placebon = 2,603reference
- Primary endpoint
- Clinical fracture (time-to-event)
- Follow-up
- Median 3.19 years
Methodological detailssubtrial, double-blind, placebo-controlled, time-to-event analysis, Fractures self-reported at every visit; medical records obtained and adjudicated
- Subtrial
- Double-blind
- Placebo-controlled
- Time-to-event analysis
- Fractures self-reported at every visit; medical records obtained and adjudicated
Primary result
Clinical fracture
Hazard ratio
1.43
95% CI 1.04–1.97
Events by treatment group
Testosteronevs Placebo
HR 1.43 (95% CI 1.04–1.97)
As reported in the abstract
Further findings
- Fracture incidence appeared higher in the testosterone group for all other fracture end points
Original publication
Testosterone Treatment and Fractures in Men with Hypogonadism. N Engl J Med. Published 18 January 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →