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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone and Men's Health Articles
Testosterone Treatment and Fractures in Men with Hypogonadism
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<blockquote data-quote="madman" data-source="post: 273928" data-attributes="member: 13851"><p>[URL unfurl="true"]https://www.nejm.org/doi/pdf/10.1056/NEJMoa2308836[/URL]</p><p></p><p></p><p><strong>Background</strong></p><p></p><p><em><strong>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.</strong></em></p><p></p><p></p><p><strong>Methods</strong></p><p></p><p><em>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, <strong>we examined the risk of clinical fracture in a time-to-event analysis.</strong> 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. <strong>At every visit, participants were asked if they had a fracture since the previous visit. If they had, medical records were obtained and adjudicated.</strong></em></p><p></p><p></p><p><strong>Results</strong></p><p></p><p><em>The full-analysis population included 5204 participants (2601 in the testosterone group and 2603 in the placebo group). <strong>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 endpoints.</strong></em></p><p></p><p></p><p><strong>Conclusions</strong></p><p></p><p><em><strong>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. (Funded by AbbVie and others; TRAVERSE ClinicalTrials.gov number, <a href="http://clinicaltrials.gov/show/NCT03518034" target="_blank">NCT03518034. opens in new tab</a>.)</strong></em></p></blockquote><p></p>
[QUOTE="madman, post: 273928, member: 13851"] [URL unfurl="true"]https://www.nejm.org/doi/pdf/10.1056/NEJMoa2308836[/URL] [B]Background[/B] [I][B]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.[/B][/I] [B]Methods[/B] [I]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, [B]we examined the risk of clinical fracture in a time-to-event analysis.[/B] 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. [B]At every visit, participants were asked if they had a fracture since the previous visit. If they had, medical records were obtained and adjudicated.[/B][/I] [B]Results[/B] [I]The full-analysis population included 5204 participants (2601 in the testosterone group and 2603 in the placebo group). [B]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 endpoints.[/B][/I] [B]Conclusions[/B] [I][B]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. (Funded by AbbVie and others; TRAVERSE ClinicalTrials.gov number, [URL='http://clinicaltrials.gov/show/NCT03518034']NCT03518034. opens in new tab[/URL].)[/B][/I] [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone and Men's Health Articles
Testosterone Treatment and Fractures in Men with Hypogonadism
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