DOSE-RESPONSE OF SEX STEROIDS ON BONE METABOLISM IN MEN AGES 60 AND OLDER

性类固醇对 60 岁及以上男性骨代谢的剂量反应

• 批准号: 7731308
• 负责人: JOEL S FINKELSTEIN
• 金额: $ 0.4万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7731308
• 关键词: Adverse effects; Age; Aging; Blood; Computer Retrieval of Information on Scientific Projects Database; Dose; Enrollment; Fatty acid glycerol esters; Funding; Gel; Goals; Gonadal Steroid Hormones; Grant; Injection of therapeutic agent; Institution; Measures; Moods; Muscle; Numbers; Patients; Placebos; Range; Research; Research Personnel; Resources; Source; Testosterone; United States National Institutes of Health; Week; bone; bone loss; bone metabolism; day; design; experience; men; muscle strength; response; size

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Lowering testosterone in men to pre-pubertal levels causes adverse effects on many body functions. Specifically, men with very low testosterone levels experience bone loss, decreased muscle strength, decreased muscle size, increased fat mass, lower sexual drive, and generally feel less well than normal men. As men age, testosterone levels decline gradually (though they rarely become extremely low) and men often experience changes in testosterone-related functions. Still, the degree to which the natural reduction of testosterone may be responsible for these adverse effects is unknown. The goal of this study is to determine the level of testosterone at which these changes begins to occur. This study will enroll 240 healthy men age > 60. Subjects will be given an injection every 4 weeks that reversible lowers their testosterone to pre-pubertal levels. (Note that when the injections are s topped, testosterone levels return promptly to normal). Each subject is also given a controlled amount of replacement testosterone gel. There are 5 possible doses of replacement testosterone (placebo, 1.25, 2.5, 5, and 10 gm/day) that are designed to produce blood testosterone levels that range from very low to normal. The dose given to each patient is randomly determined. A sixth group will receive placebos for the injection and for the testosterone gel. Over the course of 16 weeks a number of measures will be tracked including bone breakdown, muscle size and strength, fat mass, sexual drive, energy levels, and mood levels. By determining what levels of testosterone are associated with changes in these measures, clinicians may have a better idea when to treat aging men with testosterone.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 将男性的睾丸素降低到青春期前的水平会对身体的许多功能产生不利影响。具体地说，睾酮水平非常低的男性会经历骨质流失、肌肉力量下降、肌肉尺寸缩小、脂肪质量增加、性冲动降低，总体上感觉不如正常男性。随着男性年龄的增长，睾酮水平逐渐下降(尽管很少会变得非常低)，男性往往会经历与睾酮相关的功能变化。尽管如此，睾丸激素的自然减少在多大程度上可能是这些不利影响的原因尚不清楚。这项研究的目标是确定这些变化开始发生时的睾丸素水平。 这项研究将招募240名60岁的健康男性。受试者将每4周注射一次，可逆地将他们的睾丸激素降低到青春期前的水平。(请注意，当注射达到S的顶端时，睾酮水平迅速恢复正常)。每个受试者还被给予受试者一定数量的替代睾丸素凝胶。有5种可能的替代睾酮剂量(安慰剂、1.25、2.5、5和10克/天)，旨在产生从非常低到正常的血液睾酮水平。给每个病人的剂量是随机确定的。第六组将接受注射和睾酮凝胶的安慰剂。在16周的过程中，将跟踪一系列指标，包括骨骼分解、肌肉大小和力量、脂肪质量、性冲动、能量水平和情绪水平。通过确定睾丸激素水平与这些指标的变化相关，临床医生可能会更好地知道何时使用睾酮治疗老年男性。