EFFECT OF ESTROGEN ON FEMORAL NECH BONE MASS

雌激素对股骨颈骨量的影响

• 批准号: 3122882
• 负责人: Michael KLEEREKOPER
• 金额: $ 20.02万
• 依托单位: HENRY FORD HEALTH SYSTEM
• 依托单位国家: 美国
• 财政年份: 1992
• 资助国家: 美国
• 起止时间: 1992-09-30 至 1997-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3122882
• 关键词: aging; blood chemistry; bone density; clinical trials; estrogens; female; femur; high density lipoproteins; hormone therapy; human middle age (35-64); human old age (65+); human subject; human therapy evaluation; longitudinal human study; low density lipoprotein; medroxyprogesterone; photon absorptiometry; physiologic bone resorption; placebos; postmenopause; quality of life; questionnaires; radiography; spine; statistics /biometry; urinalysis; uterus

Our program is already conducting a non-intervention study of changes in bone mass and in biochemical markers of bone remodelling in women who are ten years or more post menopause and have not been exposed to postmenopausal hormone replacement therapy [HRT] (AR39657). We are about to begin a controlled clinical trial in the oldest 220 women from this 375 women cohort. That clinical trial (AG 10407) is part of the STOP/IT program and is specifically restricted to persons aged 65 years or older. In this current proposal we will recruit the remaining 155 women into a parallel controlled clinical trial examining the effectiveness of HRT in preventing bone loss from the femoral neck. This will in effect increase our STOP/IT trial size to 375, with age (less that 65, greater that 65) as a new stratum for randomization. This larger trial will allow us to address important additional questions which can not be answered in the smaller trial. Of particular importance is an assessment of whether chronologic age or years postmenopause is a more specific determinant of the "age-related" decline in bone mass and bone strength, and the responsivity to therapies aimed at retarding or reversing this process. To our knowledge this question has not previously been addressed prospectively in an aging female population. The additional power of this larger study will allow us to test the important subgroup hypothesis concerning the potential additive effects of estrogen and progesterone on bone mass. The primary outcome variable of our trial is the effect of HRT bone mass in femoral neck. Secondary outcome variables are the effect of therapy on a)spinal and total body bone mineral, b) selected biochemical markers of bone remodelling and c) some aspects of quality of life in this age group. We will also prospectively monitor the effect of HRT on serum total. HDL and LDL cholesterol, again looking separately at the effects of estrogen and estrogen plus progesterone compared to placebo.

我们的计划已经在对变化进行非干预研究 女性的骨量和骨重塑的生化标志物 绝经后十年或更长时间并且没有接触过 绝经后激素替代疗法 [HRT] (AR39657)。 我们是 即将开始对 220 名年龄最大的女性进行对照临床试验 这 375 名女性队列。 该临床试验（AG 10407）是 STOP/IT 计划，特别限于 65 岁的人 或更老。 在当前的提案中，我们将招募剩余的 155 名 女性参加一项平行对照临床试验，检查 HRT 在预防股骨颈骨质流失方面的有效性。 随着年龄的增长，这实际上会将我们的 STOP/IT 试验规模增加到 375 人 （小于 65，大于 65）作为随机化的新层。 这项更大规模的试验将使我们能够解决重要的额外问题 在较小的试验中无法回答的问题。 特别是 重要性是评估实际年龄还是岁数 绝经后是“年龄相关”的更具体的决定因素 骨量和骨强度下降，以及对 旨在延缓或逆转这一过程的疗法。 致我们的 知识这个问题以前没有被前瞻性地解决过 在老龄化的女性人口中。 这个更大的附加功率 研究将使我们能够检验有关的重要亚组假设 雌激素和孕激素对骨骼的潜在累加效应 大量的。 我们试验的主要结果变量是 HRT 的效果 股骨颈的骨量。 次要结果变量是效果 a) 脊柱和全身骨矿物质 b) 选定的治疗方法 骨重塑的生化标志物和 c) 质量的某些方面 这个年龄段的生活。 我们还将前瞻性地监测 HRT 对血清总量的影响。 HDL 和 LDL 胆固醇，再次查看 分别观察雌激素和雌激素加孕激素的影响 与安慰剂相比。