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Study Recommends Not Using Hormone Therapy for Bone Loss

By DENISE GRADY

Published: October 1, 2003

ormone 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.

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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.