Testosterone Treatment and Fractures in Men with Hypogonadism

This subtrial of the TRAVERSE study evaluated the effect of testosterone therapy on fracture risk in middle-aged and older men (45–80 years) with hypogonadism (two testosterone levels <300 ng/dL) and preexisting or high cardiovascular risk. In a double-blind, placebo-controlled trial, 5204 participants were randomized to daily testosterone gel or placebo. After a median follow-up of 3.19 years, clinical fractures occurred in 3.50% of the testosterone group versus 2.46% in the placebo group (hazard ratio, 1.43; 95% CI, 1.04–1.97). Testosterone was associated with numerically higher fracture rates across all end points, including non-high-impact fractures (2.88% vs. 2.19%) and major osteoporotic fractures (1.38% vs. 1.15%). Despite prior evidence that testosterone improves bone density and structure, this study found no protective effect against fractures, with a potential increased risk. The findings highlight the need to weigh fracture risk against other benefits (e.g., improved sexual function, mood) when considering testosterone therapy in hypogonadal men.

This subtrial of the TRAVERSE study evaluated the effect of testosterone therapy on fracture risk in middle-aged and older men (45–80 years) with hypogonadism (two testosterone levels <300 ng/dL) and preexisting or high cardiovascular risk. In a double-blind, placebo-controlled trial, 5204 participants were randomized to daily testosterone gel or placebo. After a median follow-up of 3.19 years, clinical fractures occurred in 3.50% of the testosterone group versus 2.46% in the placebo group (hazard ratio, 1.43; 95% CI, 1.04–1.97). Testosterone was associated with numerically higher fracture rates across all end points, including non-high-impact fractures (2.88% vs. 2.19%) and major osteoporotic fractures (1.38% vs. 1.15%). Despite prior evidence that testosterone improves bone density and structure, this study found no protective effect against fractures, with a potential increased risk. The findings highlight the need to weigh fracture risk against other benefits (e.g., improved sexual function, mood) when considering testosterone therapy in hypogonadal men.