A recent study found that testosterone treatment in middle-aged and older men with hypogonadism did not lower the risk of clinical fractures compared to placebo. Instead, a higher fracture incidence was observed among men who received testosterone therapy.
Published in The New England Journal of Medicine, the double-blind, randomized, placebo-controlled trial, funded by AbbVie and others, included 5,204 participants between the ages of 45 and 80. All participants had preexisting or high cardiovascular risk, hypogonadal symptoms, and fasting testosterone levels below 300 ng/dL (10.4 nmol/L) confirmed by two separate morning measurements.
Participants applied a testosterone or placebo gel daily and were followed for a median of 3.19 years. Fracture events were reported at follow-up visits, verified through medical record adjudication.
It was found out that 91 participants (3.50%) in the testosterone group experienced a clinical fracture compared to 64 participants (2.46%) in the placebo group. The hazard ratio for fracture in the testosterone group was 1.43 (95% CI, 1.04–1.97), indicating a statistically significant higher risk compared to placebo.
"Among middle-aged and older men with hypogonadism, testosterone treatment did not result in a lower incidence of clinical fracture than placebo," Peter J. Snyder, M.D. of the Perelman School of Medicine, University of Pennsylvania said, explaining that the "fracture incidence was numerically higher among men who received testosterone than among those who received placebo."
While testosterone treatment has been shown in prior studies to improve bone density and quality, this study underscores that increased bone density does not necessarily translate into lower fracture rates. Clinicians should carefully weigh the potential risks and benefits of testosterone therapy in men with hypogonadism, particularly when considering its impact on skeletal health.
In addition, the study population included men with high cardiovascular risk, which may limit generalizability to other populations. Further research is warranted to explore whether different doses, formulations, or longer follow-up durations would alter the findings.
The study was funded by AbbVie and other entities. Full disclosure forms for all authors are available in the original publication.