Bone Sparing Effects of Soy Phytoestrogens in Menopause

大豆植物雌激素对更年期骨质的保护作用

• 批准号: 6918516
• 负责人: SILVINA LEVIS
• 金额: $ 64.8万
• 依托单位: UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-01 至 2009-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6918516
• 关键词: bone density; clinical research; clinical trials; collagen; emotions; endocrine disorder; endocrine disorder chemotherapy; estrogen receptors; estrogens; female; flavones; human subject; human therapy evaluation; longitudinal human study; mammography; menopause; osteoporosis; photon absorptiometry; phytoestrogens; psychological tests; quality of life; sample collection; sign /symptom; soybeans; urinalysis; women' s health

DESCRIPTION: (provided by applicant) Women will live a third of their lives in menopause. The complications of prolonged estrogen deficiency during the menopausal years are well established. Although hormone replacement therapy (HRT) can spare women some of these complications, the Women's Health Initiative findings indicate significant potential health risks, risks that prompt more and more women to turn from prescribed HRT to over-the-counter products in the hope that soy phytoestrogens and other "estrogens" from natural sources can replace prescription estrogens in terms of benefits while sparing critical side effects. In spite of the fairly widespread and now rapidly growing use o f phyto estrogens, maj or gap s remain in our knowledge o f their long-term efficacy and safety. We propose to conduct a "Soy Phytoestrogens As Replacement Estrogen (SPARE)" study in young menopausal women to evaluate the effectiveness of a 2-year treatment with purified soy isoflavones in preventing bone loss. Our study will also explore the effectiveness of oral isoflavones in preventing menopausal symptoms and other changes associated with estrogen deficiency. The study will characterize the actions of a defined preparation of soy isoflavones in humans and will correlate these actions with the circulating serum levels of the principal isoflavone metabolites, providing new insights on their long term biological actions. This 5-year study will provide a foundation of knowledge from which menopausal women can begin to make more informed decisions regarding HRT and menopausal signs and symptoms.

描述：（由申请人提供）妇女将生活在更年期三分之一的生活。绝经期长期雌激素缺乏的并发症是众所周知的。虽然激素替代疗法（HRT）可以使女性免于这些并发症，但妇女健康倡议的研究结果表明，存在重大的潜在健康风险，这些风险促使越来越多的女性从处方HRT转向非处方产品，希望大豆植物雌激素和其他天然来源的“雌激素”可以取代处方雌激素，同时避免严重的副作用。尽管植物雌激素的使用相当广泛，而且现在正在迅速增长，但我们对其长期有效性和安全性的认识仍存在很大差距。我们建议在年轻的绝经期妇女中进行一项“大豆植物雌激素替代雌激素（SPARE）”研究，以评估用纯化大豆异黄酮治疗2年预防骨质流失的有效性。我们的研究还将探讨口服炔雌醇在预防绝经期症状和其他与雌激素缺乏相关的变化方面的有效性。该研究将描述大豆异黄酮的定义制剂在人体中的作用，并将这些作用与主要代谢物的循环血清水平相关联，为其长期生物学作用提供新的见解。这项为期5年的研究将提供一个知识的基础，从更年期妇女可以开始作出更明智的决定，关于HRT和更年期体征和症状。