‘Big surprise’ and a mystery: Testosterone increased fracture risk
The fracture data were presented by Peter J. Snyder, MD, of the University of Pennsylvania, who earlier in the session had received an Endocrine Society award for his work in the testosterone field.
“No prior trial of testosterone treatment of hypogonadal men has been large enough or long enough to assess its effect on fractures ... until the TRAVERSE trial,” he said.
The hypothesis going in was that testosterone would decrease the fracture incidence, since prior data had suggested it improves many parameters of bone quality in elderly men and in those with severe hypogonadism.
Instead, there were 91 confirmed and adjudicated clinical fractures in the testosterone group versus 64 in the placebo group, giving a hazard ratio of 1.43 (P = .03). The risk was seen across fracture types, increasing the likelihood that this finding was, in fact, real, Dr. Snyder said.
“We could speculate about a possible mechanism, but because we did not expect these results, we did not design the trial to evaluate a possible mechanism,” Dr. Snyder noted.
Dr. Anawalt told this news organization that the fracture finding “was a big surprise. None of us would have expected that there would be an increase in fractures.”
Clinically, Dr. Anawalt said it suggests consideration of expanding the use of anti-osteoporotic medication such as bisphosphonates to men with low testosterone and elevated fracture risk for whom clinicians may have assumed that just giving them testosterone replacement might also protect their bones.
“This begs the question should we reorient the way we’re thinking about these men.”
The study was funded by AbbVie, Acerus Pharmaceuticals Corporation/Aytu Biosciences, Allergan Sales, Endo Pharmaceuticals, and Upsher-Smith Laboratories. Dr. Bhasin has disclosed grants to his institution from Function Promoting Therapies and Metro International Biotech, and owns stock in XYone. Dr. Anawalt has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
This article was updated 6/19/23.