Bone Sparing Effects of Soy Phytoestrogens in Menopause

描述：（由申请人提供）女性一生中有三分之一的时间处于更年期。绝经期雌激素长期缺乏的并发症是公认的。尽管激素替代疗法（HRT）可以使女性避免一些这些并发症，但妇女健康倡议组织的研究结果表明，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激素替代疗法转向非处方产品，希望大豆植物雌激素和其他天然“雌激素”能够在避免严重副作用的同时，在益处方面取代处方雌激素。尽管植物雌激素的使用相当广泛，而且现在正在迅速增长，但我们对其长期疗效和安全性的了解仍然存在重大差距。我们建议在年轻绝经妇女中开展一项“大豆植物雌激素作为替代雌激素（SPARE）”研究，以评估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异黄酮在预防更年期症状和其他与雌激素缺乏相关的变化方面的有效性。该研究将描述一种大豆异黄酮制剂在人体中的作用，并将这些作用与主要异黄酮代谢物的循环血清水平联系起来，为其长期生物作用提供新的见解。这项为期5年的研究将为更年期妇女提供基础知识，使她们能够开始就激素替代疗法和更年期体征和症状做出更明智的决定。

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.