N Engl J Med
Testosterone fails to cut fracture rate in men with hypogonadism
Among middle-aged and older men with hypogonadism in this randomized trial, treatment with testosterone gel over a period of 3 years didn’t lower the incidence of clinical fracture compared with placebo. In fact, fracture incidence was numerically higher among testosterone recipients.
- In a subtrial of the phase 4 double-blind, randomized, placebo-controlled TRAVERSE trial that assessed the CV safety of testosterone treatment in middle-aged and older men with hypogonadism, researchers examined the risk of clinical fracture in a time-to-event analysis. Participants were ages 45 to 80 years with preexisting, or high risk of, CV disease; ≥1 symptom of hypogonadism; and two morning testosterone levels of <300 ng/dL obtained ≥48 hours apart. Participants were randomly assigned to apply testosterone or placebo gel daily. At each visit, participants were asked if they'd had a fracture since the previous visit. If they had, medical records were reviewed and adjudicated.
- The study population included 5,204 participants (2,601 in the testosterone group and 2,603 in the placebo group). During a median follow-up of 3.19 years, a clinical fracture had occurred in 91 participants (3.50%) in the testosterone group and 64 participants (2.46%) in the placebo group (hazard ratio, 1.43; 95% confidence interval, 1.04-1.97). Findings were similar for other fracture endpoints assessed, including non-high-impact clinical fractures and clinical fractures among men not taking osteoporosis medication.
Source:
Snyder PJ, et al. (2024, January 18). N Eng J Med. Testosterone Treatment and Fractures in Men with Hypogonadism. https://pubmed.ncbi.nlm.nih.gov/38231621/