Testosterone treatment offers no protection against fractures in men with hypogonadism

Testosterone treatment does not help lower the incidence of clinical fractures in middle-aged and older men with hypogonadism, according to a study.

Researchers conducted a subtrial within a double-blind, randomized, placebo-controlled trial wherein the cardiovascular safety of testosterone treatment was assessed in middle-aged and older men with hypogonadism. The risk of clinical fracture was evaluated in a time-to-event analysis.

The full-analysis population included 5,204 men between 45 and 80 years of age (mean 63 years) who had pre-existing or were at high risk of cardiovascular disease. All men presented with one or more symptoms of hypogonadism and had two morning testosterone concentrations of <300 ng/dL (10.4 nmol per litre) in fasting plasma samples obtained at least 48 hours apart. The median testosterone level at baseline was 227 ng/dL.

The men were randomly assigned to groups that applied a testosterone gel (n=2,601) or a placebo gel (n=2,603) daily. At every visit, the men reported if they had had a fracture since the previous visit. If a fracture had occurred, medical records were obtained and adjudicated.

Over a median follow-up of 3.19 years, men in the testosterone group had a higher incidence of a clinical fracture (excluding sternum, fingers, toes, skull, and face) compared with those in the placebo group (3.50 percent vs 2.46 percent; hazard ratio, 1.43, 95 percent confidence interval, 1.04–1.97).