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妇女健康倡议:自 1992 年以来骨骼研究的标志性资源。

The Women's Health Initiative: A Landmark Resource for Skeletal Research Since 1992.

机构信息

Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, USA.

Division of General Internal Medicine and Health Services Research, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, CA, USA.

出版信息

J Bone Miner Res. 2020 May;35(5):845-860. doi: 10.1002/jbmr.4026. Epub 2020 Apr 21.

DOI:10.1002/jbmr.4026
PMID:32286708
Abstract

The Women's Health Initiative (WHI) is a large longitudinal study designed to investigate strategies for the prevention and control of common chronic diseases in postmenopausal women, including cardiovascular disease, cancer, and osteoporotic fractures. The WHI consisted of three overlapping clinical trials of hormone therapy, diet modification to reduce total dietary fat, and calcium/vitamin D supplementation. Women who were ineligible for the hormone therapy or diet modification trials or not interested were invited to participate in the observational study. Women were recruited into WHI from 1993 to 1998 at 40 US clinical centers. WHI enrolled 26,046 underrepresented minority women and 135,762 white women. Women could participate in each trial if eligible. The final enrollment included 27,347 women in the hormone trial; 48,835 women in the diet modification trial; 36,282 women in the calcium/vitamin D trial, and 93,676 in the observational study. After the main study ended in 2005, women were invited to continue follow-up for exposures and outcomes through two extensions to 2020. Proposals were recently submitted to continue follow-up through 2027. Information was collected on an extensive number of risk factors for fractures at baseline and over the follow-up, including fall and fracture history, weight patterns, comorbidities, diet, reproductive history, medications, anthropometry, and biomarkers. Bone mineral density was measured at three WHI clinical centers (n = 11,020) chosen to maximize race/ethnic diversity. WHI encourages outside investigators to make use of the publicly available WHI data and to access the biobank of specimens (www.whi.org). © 2020 American Society for Bone and Mineral Research.

摘要

妇女健康倡议(WHI)是一项大型纵向研究,旨在研究绝经后妇女常见慢性疾病(包括心血管疾病、癌症和骨质疏松性骨折)的预防和控制策略。WHI 由三项重叠的激素治疗临床试验、旨在减少总膳食脂肪的饮食改变以及钙/维生素 D 补充组成。不符合激素治疗或饮食改变试验条件或不感兴趣的妇女被邀请参加观察性研究。WHI 于 1993 年至 1998 年在美国 40 个临床中心招募了 26046 名代表性不足的少数族裔妇女和 135762 名白人妇女。如果符合条件,妇女可以参加每项试验。最终入组的激素试验有 27347 名妇女;饮食改变试验 48835 名;钙/维生素 D 试验 36282 名;观察性研究 93676 名。主要研究于 2005 年结束后,邀请妇女参加两个扩展研究,继续随访至 2020 年,以了解暴露和结局情况。最近提交了继续随访至 2027 年的提案。在基线和随访期间收集了大量与骨折相关的危险因素信息,包括跌倒和骨折史、体重变化模式、合并症、饮食、生育史、药物、人体测量学和生物标志物。在三个选择以最大限度提高种族/民族多样性的 WHI 临床中心(n=11020)测量了骨矿物质密度。WHI 鼓励外部研究人员利用公开可用的 WHI 数据并访问标本生物库(www.whi.org)。©2020 美国骨矿研究协会。

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