• Peter J Snyder, Douglas C Bauer, Susan S Ellenberg, Jane A Cauley, Kevin A Buhr, Shalender Bhasin, Michael G Miller, Nader S Khan, Xue Li, and Steven E Nissen.
• From the Perelman School of Medicine, University of Pennsylvania, Philadelphia (P.J.S., S.S.E.); the San Francisco Coordinating Center, University of California, San Francisco, San Francisco (D.C.B.); the University of Pittsburgh Graduate School of Public Health, Pittsburgh (J.A.C.); the University of Wisconsin Statistical Data Analysis Center, Madison (K.A.B.); Brigham and Women's Hospital, Harvard Medical School, Boston (S.B.); AbbVie, North Chicago, IL (M.G.M., N.S.K., X.L.); and the Cleveland Clinic Coordinating Center for Clinical Research, Cleveland Clinic, Cleveland (S.E.N.).
• N. Engl. J. Med. 2024 Jan 18; 390 (3): 203211203-211.

BackgroundTestosterone treatment in men with hypogonadism improves bone density and quality, but trials with a sufficiently large sample and a sufficiently long duration to determine the effect of testosterone on the incidence of fractures are needed.MethodsIn a subtrial of a double-blind, randomized, placebo-controlled trial that assessed the cardiovascular safety of testosterone treatment in middle-aged and older men with hypogonadism, we examined the risk of clinical fracture in a time-to-event analysis. Eligible men were 45 to 80 years of age with preexisting, or high risk of, cardiovascular disease; one or more symptoms of hypogonadism; and two morning testosterone concentrations of less than 300 ng per deciliter (10.4 nmol per liter), in fasting plasma samples obtained at least 48 hours apart. Participants were randomly assigned to apply a testosterone or placebo gel daily. At every visit, participants were asked if they had had a fracture since the previous visit. If they had, medical records were obtained and adjudicated.ResultsThe full-analysis population included 5204 participants (2601 in the testosterone group and 2603 in the placebo group). After 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 to 1.97). The fracture incidence also appeared to be higher in the testosterone group for all other fracture end points.ConclusionsAmong 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. (Funded by AbbVie and others; TRAVERSE ClinicalTrials.gov number, NCT03518034.).Copyright © 2024 Massachusetts Medical Society.

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