TESTOSTERONE THERAPY IN THE HYPOGONADAL AGING MALE

性腺机能减退的老年男性的睾酮治疗

• 批准号: 2052192
• 负责人: JOYCE S. TENOVER
• 金额: $ 20.88万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1992
• 资助国家: 美国
• 起止时间: 1992-09-01 至 1996-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2052192
• 关键词: adipose tissue; aging; blood cell count; blood chemistry; blood lipoprotein; body composition; bone density; bone metabolism; clinical trials; densitometry; dihydrotestosterone; drug adverse effect; hip; hormone therapy; human old age (65+); human subject; human therapy evaluation; hypogonadism; libido; longitudinal human study; male; muscle strength; muscle tension; oxidoreductase inhibitor; physiologic bone resorption; placebos; prostate; reproductive system disorder chemotherapy; spine; striated muscles; testosterone; urinalysis

The long term objective of this application is to provide information about the efficacy of testosterone (T) replacement therapy, in hypogonadal elderly men, in preventing physical frailty by arresting bone density loss and increasing muscle mass, strength, and balance. Impaired muscle strength, falls, and fractures contribute to the development of physical frailty in the elderly. In young men, androgens are known to have positive effects on formation and maintenance of male muscle and bone, and T replacement therapy in young hypogonadal men has been shown to increase bone density and muscle mass. Although a significant number of elderly men are hypogonadal, little is known about the benefits and risks of androgen replacement in this population. Using a double-blind placebo controlled design, men greater than or equal to 65 years of age, who are not yet frail but have a serum T level below the normal range for young adult men, will be given T replacement for 3 years. An additional group will be given T plus a 5alpha-reductase inhibitor, which is being utilized both as a means to.elucidate the relative roles of T and dihydrotestosterone (DHT) in the androgen effects on muscle and bone, and as a means of protecting the prostate from increased androgen levels. During the 3 year treatment period, men will receive bone density measurements of the spine and hip, evaluation of biochemical parameters of bone turnover, extremity muscle strength testing, evaluation of balance, measurement of body composition, and evaluation of parameters related to potential adverse effects of androgen therapy (prostate, lipoproteins, hematocrit, and libido). The proposal specifically aims to study whether T replacement (1) has positive effects on bone and muscle by preventing bone density loss and increasing muscle mass, strength and balance, (2) has its effects without needing conversion to the other major androgen, DHT, and (3) can be given safely to elderly hypogonadal men.

该应用程序的长期目标是提供有关 睾丸激素（T）替代疗法的功效，在性交中 老年人，通过阻止骨密度损失来防止身体虚弱 并增加肌肉质量，力量和平衡。 肌肉受损 力量，跌落和裂缝有助于身体发展 老年人脆弱。 在年轻人中，雄激素有阳性 对男性肌肉和骨骼的形成和维持的影响，以及 已证明年轻性肾上腺肿男性的替代疗法会增加 骨密度和肌肉质量。 虽然有大量的老人 是性交，对雄激素的益处和风险知之甚少 在这个人群中取代。 使用双盲安慰剂控制 设计，大于或等于65岁的男人，尚未脆弱 但是，年轻人的血清T水平低于正常范围，将 可以替换3年。 将给予另一组 再加上5alpha-reductase抑制剂，这两者都被用作手段 阐明T和二氢睾丸激素（DHT）在 雄激素对肌肉和骨骼的影响，作为保护 从雄激素水平升高的前列腺。 在三年治疗中 时期，男性将获得脊柱和臀部的骨密度测量 评估骨骼更新，肢体肌肉的生化参数 力量测试，平衡评估，身体成分的测量， 并评估与潜在不良影响的参数 雄激素治疗（前列腺，脂蛋白，血细胞比容和性欲）。 这 提案专门旨在研究t替换（1）是否具有正面 通过预防骨密度损失并增加对骨骼和肌肉的影响 肌肉质量，力量和平衡，（2）有其影响而无需 可以安全地将转换为其他主要的雄激素，DHT和（3） 老年性次生男性。