About OPUSProject Summary: The Safety, Efficacy, and Optimal Dosage of Soy Isoflavones to Prevent OsteoporosisOver-the-counter soy isoflavone supplement usage is becoming common among postmenopausal women. However, there is no documented scientific evidence of its long-term safety and efficacy in preventing osteoporosis. Our primary goal is to determine the safety, efficacy, and optimal dosage of isoflavone supplementation to reduce bone loss in postmenopausal women. Our secondary goal is to communicate the scientific results in readily understandable terms to consumers. Four hundred healthy, postmenopausal women will be enrolled at three U.S. sites in a 2-year follow-up, randomized, double-blind, placebo-controlled study. One-third of these women will receive a placebo; one-third will receive isoflavone supplementation at 80 mg/day; and the remaining one-third will receive isoflavone supplementation at 120 mg/day. To monitor safety, mammograms, well-woman examinations, Pap smears, stool guaiac tests, and clinical blood chemistries will be performed. To monitor efficacy, total body and regional bone mineral content and density, as well as biochemical bone markers, will be measured. To determine optimal dosage, changes in bone measurements will be related to blood isoflavone concentrations. Osteoporosis awareness programs including science-based information on the health benefits of soy isoflavones, conducted by the Cooperative Extension Service, will improve the knowledge and skills of consumers enabling them to make informed food choices. The multi-state, multi-institutional design ensures that the study results are representative of postmenopausal women in the U.S. population. Confirming the skeletal benefits of soy isoflavones could translate into reduced healthcare costs related to osteoporosis, thus increasing the production, sales, and consumption of an important U.S. agricultural product. Investigators:William W. Wong, Ph.D.1, Ronald L. Young, M.D.1, Paula Amato, M.D.1, Kenneth J. Ellis, Ph.D.1, E. O’Brian Smith, Ph.D.1, Richard D. Lewis, Ph.D.2, Mary A. Johnson, Ph.D.2, Margaret A. Cramer, M.D.2, Joan Fischer, Ph.D.2, Francene M. Steinberg, Ph.D.3, Michael J. Murray, M.D.4, Stephen Barnes, Ph.D.5, and Sharon F. Robinson, Ph.D.6 OPUS Impact StatementWith approximately 20 million American women already afflicted with osteoporosis and approximately 76 million baby boomers reaching 50, the total U.S. cost of health care is projected to surpass $16 trillion in 2030. The phenomenal health-care cost is driven largely by the expense of caring for older Americans who have lost the ability to live independently. Osteoporosis is among the major causes of loss of independence. Although hormone replacement therapy has been shown to be effective to reduce the risk of bone fracture, prolonged usage has been documented to increase the risks of breast cancer, endometrial cancer, and ovarian cancer. Soy isoflavones, with chemical structures similar to specific estrogen receptor modulators such as tamoxifen, have been shown to reduce bone loss in short-term studies. The project represents the first multi-site, long-term study to document, concurrently, the safety, effectiveness, and optimal dosage of soy isoflavone supplementation to prevent bone loss in postmenopausal women. The project will provide consumers and their primary-care physicians science-based information to enable them to make an informed decision on the use of a dietary supplement to prevent osteoporosis. Preventing osteoporosis will, in turn, help to reduce health care costs. |
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