The Women S Health Initiative

The Women’s Health Initiative

The Women’s Health Initiative, known as WHI, consists of several interrelated studies, described below, whose overall objective is to prevent cancer, heart disease and osteoporosis in post-menopausal women and to identify risk factors for these and other diseases of older women. WHI consists of a set of multi-center Clinical Trials and an Observational Study to address the health of post-menopausal women. There are 40 clinical centers and nationally 161,809 women ages 50-79 at baseline are participating nationally. Follow-up is for 10-12 years. WHI is sponsored by the NIH under the auspices of the NHLBI. The WHI is scheduled to be complete in 2005.

The WHI clinical center at the Albert Einstein College of Medicine has enrolled nearly 5000 women, under the leadership of Principal Investigator Dr. Sylvia Wassertheil-Smoller, with Co-Investigators Dr. Ruth Freeman, Dr. Judith Wylie-Rosett, Dr. David Barad, Dr. Tom Rohan, Dr. Yasmin Mossavar-Rahmani. The WHI clinic is located at 1695 Eastchester Road, Bronx, NY, 10461, Suite 505, 718-931-1010. Clinic Manager is Mimi Goodwin.

In summary,

• The Hormone Therapy Trials are two randomized, placebo-controlled, double-blind clinical trials to determine if hormone therapy will prevent heart disease, colorectal cancer and osteoporotic fractures and to determine if it will increase risk of breast cancer. One trial is for women who have an intact uterus (no hysterectomy at start of trial) and who are randomized to either estrogen plus progestin or placebo. This trial was stopped in July 20002 because of an increased risk of breast cancer and lack of overall benefit of estrogen plus progestin. The second trial is for women who have had a hysterectomy at the beginning of the WHI and who were randomized to either estrogen alone or placebo. This trial is continuing.

• The Dietary Modification Trial is a randomized study of a dietary intervention to lower fat and increase grain and fruit and vegetable intake, to determine if, when compared to usual diet, this modification will lower rates of breast cancer, heart disease, and colorectal cancer;

• The Calcium/Vitamin D trial is a randomized, placebo-controlled, double-blind clinical trial to determine if this supplementation will lower osteoprotic fractures and colorectal cancer.

• The Observational Study is a long-term follow up study to identify and assess the impact of biological, genetic and lifestyle risk factors for these and other diseases.

WHI-Memory Study (WHIMS) is a separately funded ancillary study to WHI in which 39 centers are participating, to determine whether hormone replacement therapy prevents or delays the onset of Alzheimer’s disease and age-associated cognitive decline in women 56 years or older who are enrolled in the WHI hormone trials. Funding is in addition to WHI . It has been found, in the estrogen plus progestin trial, that this preparation confers a two-fold increase in risk of dementia. The estrogen alone trial is continuing and it is not know what the effects of estrogen alone are on dementia or cognitive functioning.

• Women’s Health Initiative Study of Cognitive Aging (WHISCA), another separately funded ancillary study isto find out how women who take estrogen or estrogen plus progestin compare on memory and thinking abilities over time with women who do not take hormones.

• WHIMS-MRI – Magnetic Resonance Imaging of WHIMS participants aims to correlate brain structures to cognition

• Coronary Artery Calcification Study (CACS) – seeks to determine if estrogen plus progestin had an effect on coronary artery calcification in women who were in the estrogen plus progestin clinical trail and were ages 50-59 at entry.

Additional ancillary studies at the AlbertEinsteinCollege of Medicine are:

For more information on the Women’s Health Initiative, see the WHI website at:

WHI NEW YORK CENTER STAFF