CLIN CTR CLIN TRIAL/OBSERVATIONAL STUDY OF WHI

CLIN CTR WHI 临床试验/观察研究

• 批准号: 6347048
• 负责人: ROBERT S SCHENKEN
• 金额: $ 100.31万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
• 依托单位国家: 美国
• 财政年份: 1993
• 资助国家: 美国
• 起止时间: 1993-09-30 至 2005-09-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6347048
• 关键词: breast neoplasms; calcium; clinical research; clinical trials; colorectal neoplasms; coronary disorder; diet; disease /disorder prevention /control; disease /disorder proneness /risk; estrogens; female; hip fractures; hormone therapy; human middle age (35-64); human old age (65+); human subject; human therapy evaluation; longitudinal human study; nutrition related tag; osteoporosis; postmenopause; quality of life; questionnaires; stroke; therapy compliance; vitamin D; women's health

The Women's Health Initiative is a randomized controlled clinical trial conducted in 40 clinical centers across the United States addressing some of the most common causes of death, disability, and impaired quality of life in postmenopausal women ages 50-79: cardiovascular disease; breast and colon cancer; and osteoporosis. The three components of this disease prevention trial are: (1) hormone replacement therapy with a primary outcomes of coronary heart disease and stroke and secondary outcomes of hip and other fractures; (2) low fat dietary intervention with primary outcomes of breast cancer and colorectal cancer and a secondary outcome of coronary heart disease; and (3) calcium and vitamin D supplementation with a primary outcome of hip fractures and secondary outcomes of colorectal cancer and combined fractures. A concurrent observational study will provide estimates of health effects of known risk factors and new predictors for disease. Each clinical center will collect data through questionnaires and biological specimens over 8-12 years.

妇女健康倡议是一项随机对照临床研究 在美国 40 个临床中心进行的试验 解决一些最常见的死亡、残疾和死亡原因 50-79 岁绝经后女性的生活质量受损： 心血管疾病；乳腺癌和结肠癌；和骨质疏松症。 该疾病预防试验的三个组成部分是：(1) 激素替代疗法的主要结局是冠心病 心脏病和中风以及髋关节和其他疾病的次要结局 骨折； (2) 低脂饮食干预的主要结局 乳腺癌和结直肠癌的诊断结果以及次要结果 冠心病； (3)钙和维生素D 补充髋部骨折的主要结果和 结直肠癌和合并骨折的次要结局。一个 同时进行的观察性研究将提供健康状况的估计 已知风险因素和新疾病预测因素的影响。每个 临床中心将通过问卷调查收集数据 8-12 年的生物标本。