Supplement didn't prevent bone loss, study finds

CHICAGO (March 20, 2001 10:16 a.m. EST) - A supplement marketed as a
bone-building alternative to estrogen did not prevent bone loss in women
with osteoporosis, a Danish study found, and caused changes in their
disease-fighting immune systems.

The research involved ipriflavone, a synthetic form of an estrogen-like
substance found in plants such as soybeans.

It is sold as dietary supplement pills under various brand names on the
Internet and in health-food stores in the United States and several other
countries.

The study followed research suggesting that such products could benefit
bones. It was published in Wednesday's Journal of the American Medical
Association.

In the four-year study of 292 women aged 63 on average and already
diagnosed with bone-thinning osteoporosis, ipriflavone supplements had no
effect on preserving bone density.

But women who took the supplements, in standard doses of 600 milligrams
daily, were more likely than those on dummy pills to develop a reduction in
disease-fighting white blood cells called lymphocytes.

The women remained otherwise healthy, but low lymphocyte counts are a
symptom of an immune system that is potentially more vulnerable to infection.

In most of the women, the white cell counts returned to normal within two
years after they stopped taking ipriflavone.

The authors, led by Peter Alexandersen of the Center for Clinical and Basic
Research in Ballerup, Denmark, said the significance of the lymphocyte
problems was unknown.

"The relative benefit-risk ratio of ipriflavone appears low when compared
with the alternative anti-osteoporotic drugs available," the authors said.
"Its use in treatment is not supported by these data."

Osteoporosis affects more than 80 million people worldwide, including about
10 million Americans, 80 percent of them women.

Women are most susceptible because at menopause they lose naturally
occurring estrogen, which helps keep bones strong.

The Food and Drug Administration has approved five medications to treat or
prevent osteoporosis: estrogen replacement therapy, alendronate (Fosamax),
raloxifene (Evista), risedronate (Actonel) and calcitonin (Calcimar), which
have varying results.

To avoid osteoporosis, women also are advised to get adequate calcium, a
mineral that helps build strong bones. Study participants all received
calcium supplements.

Ipriflavone is not FDA approved, but has been marketed as a natural
alternative without the side effects of estrogen supplements.

"This whole idea about natural being better has an emotional component"
which isn't always scientifically proven, said Murray Favus, a University
of Chicago osteoporosis expert who was not involved in the study.

The results suggest ipriflavone "isn't the lock on getting the job done if
you want to use it to preserve bone mass," he said.

Still, he noted that the study started with 474 women and said the findings
are weakened by the high number of dropouts - 182 - including almost half
the ipriflavone takers. The results, Favus said, also don't indicate
whether ipriflavone would be beneficial for women who don't already have
low bone density.

The study was funded by Chiesi Pharmaceuticals Inc., an Italian maker of
ipriflavone. The company's Paolo Chiesi did not return telephoned and faxed
requests for comment Monday.

Journal of the American Medical Association

By LINDSEY TANNER, Associated Press
Copyright © 2001 Nando Media
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