UB First Site In Nation to Cap Recruitment For Women's Health Initiative

BUFFALO, N.Y. -- The University at Buffalo is the first of 40 sites in the U.S. to meet all its recruitment goals for the $625 million Women's Health Initiative, the largest clinical trial ever undertaken in the U.S.

UB's Department of Social and Preventive Medicine was selected in 1993 to be one of the initiative's 16 Vanguard Clinical Centers. These sites established the study's design and developed the operating procedures for the remaining centers. A total of 4,000 women in Western New York have volunteered to take part in this landmark study.

The WHI's goal is to arrive at definitive answers concerning the relationship of hormone replacement therapy and various aspects of diet on women's long-term health. A third aspect of the project, the observational study, involves tracking women over the 12-year study period to determine lifestyle habits that are beneficial or harmful.

The study specifically will seek to determine risk factors for heart disease, the largest killer of women; breast, colon and endometrial cancers; osteoporosis, and Alzheimer's disease. The WHI eventually will involve 163,000 women nationally between the ages of 50 and 79.

Karen Falkner, Ph.D., recruitment director for UB's Vanguard Clinical Center, said being the first to reach its recruitment goals is a significant accomplishment for UB, and a testament to the generosity and insight of the women in Western New York.

"These volunteers are willing to devote a part of their lives for the next decade to helping improve the health of women for generations to come," she said. "They are part of a history-making adventure. We are very grateful for their commitment and proud of every one of them." WHI staff hosted a "Participants Appreciation Party" for volunteers in July.

The university's share of the grant for the WHI study is $11 million spread over 12 years.

UB's recruitment success in this clinical trial will help make it a prime site for future investigations, Falkner said.

Co-principal investigators on the trial are Maurizio Trevisan, M.D., professor and chair of the UB Department of Social and Preventive Medicine, and Jean Wactawski-Wende, Ph.D., UB assistant professor of gynecology and obstetrics.