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临床试验/NCT00010686
NCT00010686已完成2 期

Dietary Phytoestrogens and Bone Metabolism

National Center for Complementary and Integrative Health (NCCIH)1 个研究点 分布在 1 个国家开始时间: 2001年2月5日最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
试验地点
1

研究概览

简要总结

The purpose of this study is to determine whether dietary phytoestrogens are an effective alternative to postmenopausal exogenous estrogen replacement therapy in preventing bone loss.

详细描述

Osteoporosis in postmenopausal women is one of the most important public health challenges of our time. With millions of women affected and billions of dollars being spent for its complications, we need to develop effective approaches to this disease. Postmenopausal women are at particular risk because the loss of estrogen associated with the menopause leads to bone loss of much greater magnitude than one would expect on the basis of age alone. Estrogen replacement therapy, a logical and effective therapeutic approach, has been associated with serious concerns about adverse events and, thus, limited use. The recent development of selective estrogen receptor modulators (SERMS) may help if they continue to show promise. Interest in natural sources of estrogenic substances to prevent postmenopausal bone loss is an expected outgrowth of the general interest in alternative medicinals for a wide variety of human disorders. Concerns about the potential for adverse consequences of the conventional use of estrogen replacement therapy, and limited knowledge about long term use of SERMS- add support to this quest. No systematic investigation of the role of dietary phytoestrogens on bone mass and skeletal dynamics has yet been conducted. With the dramatic increase in interest in these sources of estrogenic activity, it is important for us to determine whether these agents are efficacious. Otherwise, this field will be plagued for years to come by incomplete, anecdotal and scientifically poorly documented actions of these agents on bone metabolism. It is our expectation that this study will begin to provide the documentary information that the field so clearly needs. The rationale for exploring the potential for phytoestrogens in the maintenance of skeletal health in postmenopausal women is clear and compelling.

Women will be randomly assigned to one of three healthy eating plans and, over the course of the year-long study, will learn to choose and cook foods to help optimize health as they go through menopause and beyond.

研究设计

研究类型
Interventional
分配方式
Randomized
主要目的
Treatment

入排标准

年龄范围
50 Years 至 72 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Postmenopausal
  • Weight within 90% to 120% of ideal body weight
  • 12 or more months since last menstrual period
  • New York Metro Area resident

排除标准

  • History of cancer, diabetes, or heart disease

研究者

研究点 (1)

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Dietary Phytoestrogens and Bone Metabolism | 临床试验