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TESTOSTERONE FOR PREVENTION OF FRACTURE IN MEN

睾酮预防男性骨折

基本信息

批准号：
7079890
负责人：
ANNE M KENNY
金额：
$ 7.47万
依托单位：
UNIVERSITY OF CONNECTICUT SCH OF MED/DNT
依托单位国家：
美国
项目类别：
财政年份：
2001
资助国家：
美国
起止时间：
2001-09-30 至 2007-06-30
项目状态：
已结题

项目摘要

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.

描述：（申请逐字逐句）对骨质疏松症的关注主要集中在女性健康上，而很少关注其诊断和预防男性骨质疏松性骨折。然而这种疾病也是一种男性的重要问题。睾酮水平随着年龄的增长而下降，并且严重的睾酮缺乏与低骨量和骨折有关。多项流行病学研究表明，睾酮水平低与老年男性骨量较低，但这一发现并不一致。有臀部的男士骨折患者比对照组更常发现睾酮缺乏科目。 70 岁以上男性睾酮水平低于年轻时的正常水平范围内，我们发现生物可利用睾酮的差异占 20 股骨下一个骨矿物质密度 (FN BMD) 值的方差百分比。根据这些数据，补充睾酮可能对骨骼很重要老年男性的健康。我们将检验以下假设：睾酮补充可以降低随后发生椎体和非椎体疾病的风险最近发生髋部骨折的老年男性骨折。我们还将评估睾酮对该群体总体健康和福祉的影响。拟议研究的具体目标是确定效果补充睾酮对椎骨和非椎骨骨折发生率的影响年龄在 60 岁及以上且最近发生过髋部骨折的男性。二一百名 60 岁及以上髋部骨折的男性轻度至中度创伤后（例如从站立高度跌落）前 2-6 个月）将被随机分配接受长效治疗双盲研究中的睾酮或安慰剂注射。我们将确定通过结构化调查问卷和随访发现新的非椎体骨折发生率每 6 个月进行一次射线照相确认，持续 36 个月，以及脊椎检查基线侧脊柱片和每年随访侧脊柱骨折率脊柱电影。此外，股骨近端的骨矿物质密度（BMD），通过双 X 射线吸收测定法 (DXA) 测量腰椎、桡骨远端和全身将在基线和每年进行一次，持续 3 年，以评估 BMD 的变化。此外，我们将确定睾酮对整体健康的影响，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状况进行评估，全身 DXA 和前列腺参数的身体成分将包括前列腺特异性抗原水平，美国泌尿外科协会前列腺前列腺症状评分和直肠指检。