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Study Recommends Not Using Hormone Therapy for Bone Loss

By Denise Grady, The New York Times

October 1, 2003

Hormone replacement therapy should no longer be prescribed solely to prevent or treat the bone-thinning disease osteoporosis, researchers said in a study being published today, disputing the policy of the Food and Drug Administration.

Even though hormones do prevent broken bones in postmenopausal women, the researchers say the benefit is not worth the risks: increased rates of heart disease, breast cancer, strokes and blood clots in the lungs.

The federal agency permits the use of Prempro, the combined hormone therapy of estrogen and progestin, a form of progesterone, to prevent osteoporosis. But agency officials will meet with researchers, including those whose work is being published today in The Journal of the American Medical Association, on Oct. 7 to evaluate the data on osteoporosis. A spokeswoman for the drug agency said it was possible that the approved uses could change.

The only other approved use of Prempro is to treat menopausal symptoms like hot flashes, night sweats and vaginal discomfort. Women are advised to take the lowest dose for the shortest time.

The medical journal report is based on a large government study, the Women's Health Initiative, which compared 8,102 women who took placebos with 8,506 who took Prempro. The study was stopped early when it became apparent that those taking hormones had a small increase in the risk of breast cancer. Its major findings were published last year. Today's report is a further analysis of the findings on bone loss.

"Even among women at high risk of fracture, there was no added benefit," said Dr. Jane Cauley, a professor of epidemiology at the University of Pittsburgh and the leading author of the study. But, she said, some women with severe hot flashes or great worry about fractures may choose to take the hormones anyway.

Wyeth, the maker of Prempro, said in a statement that decisions about hormone use should be made by women and their doctors.

 

 

 

 


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