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“WHI,” Women’s Health Initiative

 
Initiator and Sponsor
    National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH)
 
Study Principal Investigator
    Sally Schumaker, MD, Wake Forest University School of Medicine
 
Berman Center Site Principal Investigator
    Karen Margolis, MD, MPH
 
Berman Center Study Coordinator
    Cindy Bjerk
 
Berman Center Project Director
    Julie Levin
 
Description
    The Women's Health Initiative (WHI) was one of the first large, multi-site, long-term studies of women’s health. A total of 161,861 female participants were randomized to treatment arms that included dietary modification, hormone replacement, calcium and vitamin D supplementation. Their health status has been followed for more than 12 years, paying particular attention to the major causes of death and health problems in women: cancer, heart disease, and broken bones.
 
Role of the Berman Center
    The Berman Center has been one of 40 participating WHI sites since the trial’s inception in 1992. The Berman Center screened approximately 25,000 participants for eligibility, and enrolled 4,884 participants from Minnesota, Wisconsin, North Dakota and Iowa. The 90% rate of visit attendance, and the 100% study completion rate, attests both to the dedication of the participants, and the rapport established with them by Berman Center nurses, nutritionists, and study physicians.
 
Ancillary Studies
    The Women's Health Initiative Memory Study (WHIMS) is an ancillary study to the Women's Health Initiative (WHI). WHIMS was designed to determine the effects of hormone therapy (HT) on the development and progression of dementia symptoms in post menopausal women. After the 2005 conclusion of the WHI clinical trial, the WHIMS Extension will continue to study this relationship through testing for cognitive function and, if needed, lab work, CT scans, and physician interviews. Participant enrollment has concluded and the WHIMS Extension will continue through 2007.

The Women's Health Initiative Memory Study Magnetic Resonance Imaging (WHIMS-MRI) is an ancillary study to the Women's Health Initiative (WHI). WHIMS-MRI is to mount a cross sectional MRI study in approximately 1,450 women previously enrolled in WHIMS to evaluate the impact of hormone therapy (HT) on sub-clinical neurological pathology. Each enrolled participant will have one MRI scan of the brain. Summary letters will be sent to each participant and her primary physician. The Berman Center will manage the data collection and will serve as a liaison to coordinate further clinical testing if needed. Recruitment for WHIMS-MRI concluded in December 2005.
 
Abstract
   

This multi-site, longitudinal study of 161,861 post-menopausal women has concluded. It is intended to assess diet, hormone therapy, calcium, and vitamin D for their effects on cancer, heart disease, and broken bones, all major causes of problems and death in older women. The WHI Clinical Trial (CT) will evaluate the benefits and risks of hormone replacement therapy (HRT), dietary modification (DM), and supplementation with calcium/vitamin D (CaD) on the overall health of postmenopausal women. The Observational trial (OS) consists of ineligible clinical trial screenees who agreed to be followed for nine years. Two ancillary studies, WHMS Extension and WHIMS-MRI are currently being conducted.

 
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