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Release: April 22, 2002

Women invited to participate in LIFT study

The University of Iowa College of Public Health is beginning a new, five-year research study testing an investigational medication for the prevention of osteoporosis bone loss and fractures. Women, ages 60 to 80, who have osteoporosis, or a low bone density test result, are invited to participate in the LIFT Study (Long Term Intervention on Fractures with Tibolone). Many women do not know that they have low bone density. Part of the testing for the study will include having a bone density measurement of the hip and the spine.

The purpose of the research study is to compare the effectiveness of tibolone, a hormone replacement drug, to placebo (an inactive pill) in the prevention of spinal fractures in postmenopausal women who already have low bone density. During this study, researchers will look at the effects of tibolone on height, fractures and bone density of the spine and hip. Researchers also will look at the effect of tibolone on bone formation.

"If tibolone proves to be effective in preventing bone fractures, it will add an important new option for women to consider taking after menopause," said Susan Johnson, M.D., UI professor of obstetrics and gynecology and principal investigator for the LIFT Trial.

Osteoporosis is a serious concern to many women, especially after menopause. In Europe, Japan and the United States, an estimated 75 million people have osteoporosis. If present trends continue, that number is expected to double by 2020. Osteoporosis is blamed for 1.5 million fractures annually in the United States.

Bone is in a constant state of forming and resorption, or turnover. During their youth, women add more bone mass than they lose, and from age 35 to 50, the amount of bone built up and lost is about equal. After menopause, however, women begin to lose more bone than they build. During the first three to four years after menopause, annual bone loss of up to 5 percent per year is not uncommon.

Tibolone is an investigational medication. It has not been approved for use, except for research purposes, by the U.S. Food and Drug Administration (FDA). However, it has been used as hormone replacement therapy in Europe since 1988. Most recently, it has been used in Europe to treat osteoporosis.

Historically, estrogen replacement therapy has been regarded by many as the first line of treatment for the prevention of bone loss in postmenopausal women. However, side effects such as bleeding and spotting, as well as risks of cancer and blood clots of the legs or lungs, prevent some women from taking hormone therapy. Unlike estrogen, tibolone rarely causes vaginal bleeding and has no known risk of breast cancer or blood clots. Tibolone does not cause, and appears to even reduce, hot flashes.

Participants in the UI study will be asked to make 13 study visits to Iowa City. Bone density measurements, mammograms, gynecological exams and blood tests will be conducted as part of the study. Compensation is available.

For more information, call Kelly O'Berry at (319) 335-6628 or toll-free (800) 348-4692.