DOSE-RESPONSE OF SEX STEROIDS ON BONE METABOLISM IN MEN (SEE SPID 0665)

性类固醇对男性骨代谢的剂量反应（参见 SPID 0665）

• 批准号: 7731264
• 负责人: JOEL S FINKELSTEIN
• 金额: $ 1.07万
• 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/7731264
• 关键词: Adverse effects; Age; Aromatase Inhibitors; Blood; Computer Retrieval of Information on Scientific Projects Database; Daily; Dose; Enrollment; Estrogens; Fatty acid glycerol esters; Funding; Gel; Goals; Gonadal Steroid Hormones; Grant; Injection of therapeutic agent; Institution; Measures; Moods; Muscle; Numbers; Patients; Physiological; Placebos; Play; Range; Research; Research Personnel; Resources; Role; Source; Testosterone; United States National Institutes of Health; Week; Withdrawal; anastrozole; 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 and the effect of estrogen withdrawal on these dose-response relationships. This study will enroll 200 healthy men ages 20-50. Subjects will be given an injection every 4 weeks that reversible lowers their testosterone to pre-pubertal levels. (Note that when the injections are stopped, 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. All men also receive an aromatase inhibitor (anastrazole 1 mg po daily) to lower estrogen levels. 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 comparing these dose-response relationships with those from SPID 0665 we will be able to assess the role that estrogen plays in key physiologic functions in men.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 降低男性睾丸激素到前伯伯氏级，会对许多身体功能产生不利影响。 具体而言，具有非常低睾丸激素水平的男性经历骨质流失，肌肉力量降低，肌肉大小降低，脂肪质量增加，性驱动力降低，并且通常比正常男性更好。 随着男性年龄的增长，睾丸激素水平逐渐下降（尽管很少变得极低），并且男性经常经历与睾丸激素相关的功能的变化。 尽管如此，尚不清楚睾丸激素自然减少可能导致睾丸激素的程度尚不清楚。 这项研究的目的是确定这些变化开始发生的睾丸激素水平以及雌激素戒断对这些剂量反应关系的影响。 这项研究将招募200名20-50岁的健康男性。 每4周注射一次受试者，可逆将其睾丸激素降低到前伯伯氏水平。 （请注意，停止注射时，睾丸激素水平迅速返回到正常）。 每个受试者还将给予受控数量的替代睾丸激素凝胶。 有5剂替代睾丸激素（安慰剂，1.25、2.5、5和10 gm/天）旨在产生从极低到正常水平的血液睾丸激素水平。 给每个患者的剂量随机确定。 所有男性还接受芳香酶抑制剂（每天1毫克PO），以降低雌激素水平。 在16周的过程中，将采取许多措施，包括骨骼崩溃，肌肉大小和力量，脂肪质量，性驱动，能量水平和情绪水平。 通过将这些剂量反应关系与Spid 0665的剂量反应关系进行比较，我们将能够评估雌激素在男性关键生理功能中所起的作用。