THE WOMEN'S HEALTH INITIATIVE

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The Women's Health Initiative is a NIH-sponsored 13 year Clinical Trial (CT) and Observational Study (OS). The clinical trial is designed to determine the effectiveness of hormone replacement therapy, diet modification and/or calcium and vitamin D supplementation on cardiovascular disease, cancer, and osteoporosis in postmenopausal women ages 50-79 years old. A total of 63,000 women from 40 centers are being followed in this randomized clinical trial for an average of nine years. The University of Iowa has three clinic sites, one in the GCRC. Women were eligible for either the hormone replacement (HRT) or diet modification (DM) therapies or both. All eligible trial participants were invited to participate in the calcium/Vitamin D (CaD) study. The hypotheses to be tested include: 1) does HRT reduce the risk of coronary disease and osteoporosis-related fractures; 2) does DM reduce the risk of breat cancer, colorectal cancer, and coronary heart disease; and 3) does CaD reduce the risk of osteoporosis-related fractures and colorectal cancer? The study will also determine biological, behavioral, occupational and environmental risk factors for morbidity and mortality in an observational cohort of women. The OS consists of 93,721 women who were eligible for the CT or who did not want to participate in the CT. The goals of the OS are to: 1) improve prediction of coronary disease, breast cancer, colorectal cancer, fractures, and total mortality in postmenopausal women; 2) create a resource for evaluation of new hypotheses in causation of disease; and 3) examine the changes in individual characteristics on disease and total mortality.