美国宾夕法尼亚大学Peter J. Snyder团队研究了睾酮治疗男性性腺功能减退患者是否可改善骨密度和骨质量。该研究于2024年1月17日发表在《新英格兰医学杂志》上。

男性性腺功能减退症患者的睾酮治疗可以改善骨密度和骨质量，但需要足够大的样本和足够长的持续时间来确定睾酮对骨折发生率的影响。

在一项双盲、随机、安慰剂对照试验中，研究组在一项时间-事件分析中检查了临床骨折的风险，该试验评估了睾酮治疗中老年男性性腺功能减退症的心血管安全性。符合条件的男性年龄在45至80岁之间，已有心血管疾病或存在心血管疾病高风险；伴性腺功能减退的一种或多种症状；在间隔至少48小时获得的空腹血浆样本中，两次早晨睾酮浓度低于300纳克/分升（10.4毫摩尔/升）。

参与者被随机分配每天使用睾酮或安慰剂凝胶。每次就诊时，参与者都会被问及自上次就诊以来是否有骨折。如果他们有，就会获得医疗记录并进行评判。

完整的分析人群包括5204名参与者（睾酮组2601人，安慰剂组2603人）。经过3.19年的中位随访，睾酮组91名参与者（3.50%）和安慰剂组64名参与者（2.46%）发生临床骨折（风险比为1.43；95%置信区间1.04-1.97）。对于所有其他骨折终点，睾酮组的骨折发生率似乎也更高。

研究结果表明，在患有性腺功能减退症的中老年男性中，睾酮治疗并未导致临床骨折发生率低于安慰剂。接受睾酮治疗的男性骨折发生率在数字上高于接受安慰剂治疗的男性。

附：英文原文

Title: Testosterone Treatment and Fractures in Men with Hypogonadism

Author: Peter J. Snyder, Douglas C. Bauer, Susan S. Ellenberg, Jane A. Cauley, Kevin A. Buhr, Shalender Bhasin, Michael G. Miller, Nader S. Khan, Xue Li, Steven E. Nissen

Issue&Volume: 2024-01-17

Abstract:

Abstract

Background

Testosterone treatment in men with hypogonadism improves bone density and quality, but trials with a sufficiently large sample and a sufficiently long duration to determine the effect of testosterone on the incidence of fractures are needed.

Methods

In a subtrial of a double-blind, randomized, placebo-controlled trial that assessed the cardiovascular safety of testosterone treatment in middle-aged and older men with hypogonadism, we examined the risk of clinical fracture in a time-to-event analysis. Eligible men were 45 to 80 years of age with preexisting, or high risk of, cardiovascular disease; one or more symptoms of hypogonadism; and two morning testosterone concentrations of less than 300 ng per deciliter (10.4 nmol per liter), in fasting plasma samples obtained at least 48 hours apart. Participants were randomly assigned to apply a testosterone or placebo gel daily. At every visit, participants were asked if they had had a fracture since the previous visit. If they had, medical records were obtained and adjudicated.

Results

The full-analysis population included 5204 participants (2601 in the testosterone group and 2603 in the placebo group). After a median follow-up of 3.19 years, a clinical fracture had occurred in 91 participants (3.50%) in the testosterone group and 64 participants (2.46%) in the placebo group (hazard ratio, 1.43; 95% confidence interval, 1.04 to 1.97). The fracture incidence also appeared to be higher in the testosterone group for all other fracture end points.

Conclusions

Among middle-aged and older men with hypogonadism, testosterone treatment did not result in a lower incidence of clinical fracture than placebo. The fracture incidence was numerically higher among men who received testosterone than among those who received placebo.

DOI: 10.1056/NEJMoa2308836

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2308836