Testosterone Treatment and Fracture Risk in Hypogonadal Men
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Reviewed by Dat Tien Nguyen, B.A, ScM.
Translated by Nhi Phuong Quynh Le, B.A |
Posted on March 11th, 2024
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Male hypogonadism, in the form of testicular or pituitary dysfunction, is linked to decreased bone density. Previous research indicated that testosterone therapy could potentially reverse this bone loss. However, the earlier study had limitations in duration and sample size. Therefore, a clinical study was initiated to evaluate the efficacy of testosterone in preventing fractures among men with hypogonadism.
The phase 4 clinical trial enrolled 5204 men aged 45 to 80 years who had received a clinical diagnosis of hypogonadism, characterized by morning testosterone levels below 300 ng per deciliter. Participants were randomly allocated to receive transdermal treatment with a gel containing 1.62% testosterone or a placebo with similar characteristics. Following a median follow-up period of approximately 3.19 years, the findings contradicted the initial hypothesis, revealing that testosterone administration increased the risk of fracture by 43%. The study suggested that factors such as suboptimal adherence and low serum testosterone levels might have influenced the outcome. Additionally, the research did not evaluate differences in physical activity levels or risk-taking behaviors between the two groups.
The phase 4 clinical trial enrolled 5204 men aged 45 to 80 years who had received a clinical diagnosis of hypogonadism, characterized by morning testosterone levels below 300 ng per deciliter. Participants were randomly allocated to receive transdermal treatment with a gel containing 1.62% testosterone or a placebo with similar characteristics. Following a median follow-up period of approximately 3.19 years, the findings contradicted the initial hypothesis, revealing that testosterone administration increased the risk of fracture by 43%. The study suggested that factors such as suboptimal adherence and low serum testosterone levels might have influenced the outcome. Additionally, the research did not evaluate differences in physical activity levels or risk-taking behaviors between the two groups.