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Testosterone treatment does not result in a lower incidence of clinical fractures among middle-aged and older men with hypogonadism, according to a study published in the New England Journal of Medicine.
Peter J. Snyder, M.D., from the Perelman School of Medicine at the University of Pennsylvania in Philadelphia, and colleagues examined the risk for clinical fracture in a time-to-event analysis subtrial of a randomized placebo-controlled trial that evaluated the cardiovascular safety of testosterone treatment in middle-aged and older men with hypogonadism. Eligible men were aged 45 to 80 years with preexisting, or a high risk for, cardiovascular disease; one or more symptoms of hypogonadism; and two morning testosterone concentrations <300 ng/dL in fasting plasma samples obtained at least 48 hours apart. A total of 5,204 participants were randomly assigned to apply testosterone or placebo gel daily (2,601 and 2,603, respectively).
The researchers found that a clinical fracture occurred in 3.50 and 2.46 percent of participants in the testosterone and placebo groups, respectively, after a median follow-up of 3.19 years (hazard ratio, 1.43). For all other fracture end points, the fracture incidence also seemed higher in the testosterone group.
“We did not expect these results, because most previous studies showed that testosterone improved many measures of bone structure and quality,” the authors write.
The study was funded by AbbVie, Acerus Pharmaceuticals, Endo Pharmaceuticals, and Upsher-Smith Laboratories.
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