TESTOSTERONE FOR PREVENTION OF FRACTURE IN MEN

睾酮预防男性骨折

• 批准号: 6509947
• 负责人: ANNE M KENNY
• 金额: $ 36.25万
• 依托单位: UNIVERSITY OF CONNECTICUT SCH OF MED/DNT
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-30 至 2006-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6509947
• 关键词: aging; blood tests; body composition; bone density; bone fracture; cardiovascular function; clinical trials; cognition; disease /disorder prevention /control; geriatrics; hormone regulation /control mechanism; hormone therapy; human old age (65+); human subject; human therapy evaluation; male; osteoporosis; patient oriented research; prostate; quality of life; questionnaires; radiography; statistics /biometry; testosterone; urinalysis

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：（逐字引用自申请）对骨质疏松症的关注在很大程度上 强调妇女的健康，很少关注诊断 和预防男性骨质疏松性骨折。然而，这种疾病也是一种 男人的重要问题睾酮水平随着年龄的增长而下降， 严重的睾酮缺乏与低骨量和骨折有关。 一些流行病学研究表明，低睾酮与 老年男性骨量低，但这一发现并不一致。男性臀部 骨折被发现是睾酮缺乏更经常比对照组 科目在70岁以上睾丸激素水平低于年轻正常水平的男性中， 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。 基于这些数据，补充睾酮可能对骨骼很重要。 老年人的健康我们将检验睾丸激素 补充可以降低随后的脊椎和非脊椎 近期髋骨骨折的老年男性。我们还将评估 睾酮对这一群体的一般健康和福祉的影响。 拟议研究的具体目标是确定 补充睾酮对椎体和非椎体骨折发生率的影响 年龄在60岁及以上的男性，最近发生过髋部骨折。两 数百名60岁及以上的男性髋部骨折 在轻度至中度创伤（如从站立高度跌落）后， 前2-6个月）将随机分配接受长效 睾酮或安慰剂注射在一项双盲研究。我们会查明 通过结构性问卷调查和随访确定的新发非椎骨骨折发生率 每6个月进行一次影像学确认，持续36个月，以及椎体 基线脊柱侧位片和每年随访侧位片的骨折率 脊椎片此外，股骨近端的骨矿物质密度（BMD）， 腰椎、桡骨远端和全身双能X线吸收测定法（DXA） 将在基线时和每年进行一次，持续3年，以评估BMD的变化。 此外，我们将确定睾丸激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 组成和前列腺参数。各种身体和认知测量 将进行评估，心血管风险将通过血脂谱进行评估， 来自全身DXA和前列腺参数的身体组成将包括 前列腺特异性抗原水平，美国泌尿外科协会前列腺 症状评分和前列腺直肠指诊。