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.

我们的计划已经在进行了不干预研究的研究 骨骼质量和骨骼重塑的生化标志物中的女性 是十年或更年期后，尚未暴露于 绝经后激素替代疗法[HRT]（AR39657）。 我们是 即将在最古老的220名女性中开始对照临床试验 这个375个女队。 该临床试验（AG 10407）是 停止/IT计划，并特别限于65岁的人 或年龄较大。 在当前的建议中，我们将招募其余的155 妇女参加了一项平行控制的临床试验 HRT在防止股骨颈部骨质流失方面的有效性。 实际上，这将使我们的停止/IT试验规模增加到375，随着年龄的增长 （少65，更大65）作为随机分组的新阶层。 这个更大的试验将使我们能够解决重要的额外 在较小的试验中无法回答的问题。 特别 重要性是对年龄或年龄的评估 结肠后期是“与年龄相关”的更具体的决定因素 骨质和骨骼强度的下降，以及对 旨在延迟或逆转此过程的治疗。 向我们 知道这个问题以前尚未被预期解决 在老龄女性中。 这个较大的额外力量 研究将使我们能够检验有关有关的重要亚组假设 雌激素和孕酮对骨骼的潜在添加作用 大量的。 我们试验的主要结果变量是HRT的影响 股骨颈部的骨骼质量。 次要结果变量是效果 a）脊柱和全身骨矿物质的治疗，b）选择 骨骼重塑的生化标记和c）质量的某些方面 这个年龄段的生活。 我们还将前景监视 HRT对血清总数的影响。 HDL和LDL胆固醇，再次看 分别在雌激素和雌激素加孕酮的作用下 与安慰剂相比。