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The New England Journal of MedicineTestosterone Treatment and Fractures in Men with Hypogonadism

Testosterone Treatment in Hypogonadal Men Linked to Increased Fracture Risk

A recent comprehensive study has evaluated the impact of testosterone treatment on clinical fracture incidence in middle-aged and older men with hypogonadism. Despite the known benefits of testosterone in enhancing bone density and quality, this extensive trial sheds new light on its implications for fracture risk, thereby offering crucial insights for clinical decision-making.

Study Design:

  • Participants: Men aged 45 to 80 years, with preexisting or high risk of cardiovascular disease, symptoms of hypogonadism, and low morning testosterone levels (<300 ng/dl).
  • Methodology: Double-blind, randomized, placebo-controlled subtrial, focusing on the cardiovascular safety of testosterone treatment.
  • Treatment: Daily application of either testosterone or placebo gel.
  • Follow-up and Assessment: Median follow-up duration was 3.19 years, with regular checks for any fractures since the previous visit.

Key Findings:

  • Population: 5,204 participants (2,601 in testosterone group, 2,603 in placebo group).
  • Fracture Incidence: 3.50% in testosterone group vs. 2.46% in placebo group.
  • Risk Analysis: Hazard ratio of 1.43 (95% CI, 1.04 to 1.97), indicating higher fracture risk in the testosterone group.
  • Broader Implications: Testosterone treatment did not lower, but rather increased, the incidence of clinical fractures in this demographic.

According to the National Institute on Aging, testosterone levels naturally decline about 1% per year in men after the age of 30. This decrease can lead to various health issues, including reduced bone density and increased risk of fractures, underscoring the importance of careful management in testosterone therapy.


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