NEJM Original Article

New England Journal of Medicine, January 18, 2024

Data from a subtrial of an RCT that assessed the cardiovascular safety of testosterone treatment  in 5204 men ages 45 to 80 years of age with preexisting or high  risk of cardiovascular disease and one or more symptoms of hypogonadism and low testosterone levels. Participants were randomly assigned to apply a testosterone or placebo gel daily, and then asked at each visit if they had had a fracture since the previous visit. The median follow-up was 3.19 years.

What’s Interesting about this article?

  • Testosterone treatment in men with hypogonadism improves bone density and quality. However, there is no data on incidence of fractures with extended use in a large sample of middle-aged or older men.
  • Numerically, there was a higher incidence of fractures in men who received testosterone in this study.
  • In the original study of this group of men, there was no difference in adverse cardiovascular events in those that received testosterone rather than placebo.

JournalDoc Comments:

  • The increase in incidence of fractures in the testosterone group was a surprising result.
  • The increase in fracture risk was not large – 3.50% in the testosterone group versus 2.46% in the placebo group and most fractures were associated with trauma rather than osteoporosis.
  • However, in an accompanying editorial by Mathis Grossmann, MD, Ph.D and Bradley Anawalt, the authors recommended that older men with obesity and low testosterone should be considered at higher risk of fracture if prescribed testosterone therapy.


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