TESTOSTERONE FOR PREVENTION OF FRACTURE IN MEN

描述：(逐字引用)对骨质疏松症的关注在很大程度上强调了女性的健康，而对诊断的关注很少 和预防男性骨质疏松性骨折。然而，这种疾病也是一种 男人身上的重要问题。睾酮水平随着年龄的增长而下降，并且 严重的睾丸素缺乏与骨量减少和骨折有关。 一些流行病学研究表明，低睾丸素与 老年男性的骨量较低，但这一发现并不一致。有臀部的男人 与对照组相比，骨折患者更容易出现睾丸激素缺乏。 研究对象。在70岁以上的男性中，睾酮水平低于年轻正常水平 范围内，我们发现生物可利用型睾丸素的差异占20 股骨下一骨密度(FN BMD)值变化的百分比。 根据这些数据，补充睾丸素可能对骨骼很重要 老年男性的健康。我们将检验这一假设，即睾丸激素 补充可以降低后发性脊椎和非脊椎疾病的风险 最近髋部骨折的老年男性的骨折。我们还将评估 睾丸激素对这一群体的总体健康和幸福感的影响。 拟议研究的具体目标将是确定 补充睾酮对椎体和非椎体骨折发生率的影响 对于60岁及以上的男性，他们最近遭受了髋部骨折。二 100名60岁及以上的男性髋部骨折 在轻中度创伤(如从站立高度坠落)后 之前2-6个月)将被随机分配以获得长期有效的 在一项双盲研究中注射睾丸素或安慰剂。我们会确定 结构化问卷调查和随访的新发、非椎体骨折发生率 每6个月做一次X光检查，连续36个月，以及脊椎 脊柱侧位片基线和每年侧位随访的骨折发生率 脊椎片。此外，股骨近端的骨密度(BMD)， 腰椎、桡骨远端和全身双X射线骨密度仪 将在基线和每年进行为期3年的检查，以评估骨密度的变化。 此外，我们将确定睾丸素对一般健康的影响， 包括身体和认知功能、心血管风险、身体 成分和前列腺参数。各种身体和认知测量 将进行评估，心血管风险将通过血脂和 来自全身的身体成分DXA和前列腺参数将包括 前列腺特异性抗原水平，美国泌尿外科协会前列腺癌 症状评分和直肠指诊前列腺。

DESCRIPTION: (verbatim from application) Attention to osteoporosis has largely emphasized women's health, and little attention has focused on the diagnosis and prevention of osteoporotic fractures in men. And yet the disease is also an important problem in men. Tesosterone levels decline with advancing age, and severe testosterone deficiency is associated with low bone mass and fracture. Several epidemiologic studies suggest that low testosterone is associated with low bone mass in older men, but this finding is not consistent. Men with hip fracture are found to be testosterone deficient more often than control subjects. Among men over age 70 with testosterone levels below young normal range, we found differences in bioavailable testosterone accounted for 20 percent of the variance in femoral next bone mineral density (FN BMD) values. Based on these data, testosterone supplementation may be important for bone health in older men. We will test the hypothesis that testosterone supplementation can decrease the risk of subsequent vertebral and non-vertebral fractures in older men with recent hip fracture. We will also evaluate the effects of testosterone on general health and well-being in this group. The specific aims of the proposed study will be to determine the effect of testosterone supplementation on vertebral and non-vertebral fractures incidence in men, age 60 years and older, who have sustained a recent hip fracture. Two hundred men, age 60 years and older, who have sustained a hip fracture following mild to moderate trauma (such as a fall from a standing height in the previous 2-6 months) will be randomly assigned to receive either long-acting testosterone or placebo injections in a double-blind study. We will ascertain new, non vertebral fracture incidence by structured questionnaire and follow-up radiographic confirmation every 6 months for 36 months, as well as vertebral fracture rates with baseline lateral spine films and yearly follow-up lateral spine films. In addition, bone mineral density (BMD) of the proximal femur, lumbar spine, distal radius and total body by dual x-ray absorptiometry (DXA) will be performed at baseline and yearly for 3 years to assess changes in BMD. In addition, we will determine the effect of testosterone on general health, including physical and cognitive function, cardiovascular risk, body composition and prostate parameters. Various physical and cognitive measures will be assessed, cardiovascular risk will be assessed by lipid profile and body composition from the whole body DXA and prostate parameters will include prostate specific antigen levels, American Urologic Association Prostate Symptom Score and digital rectal examination of the prostate.