New Bone Drug May Prevent Fractures But Raise Clot Risk

It's too soon to say if it outperforms existing drugs, expert says

By Kathleen Doheny
HealthDay Reporter

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WEDNESDAY, Feb. 24 (HealthDay News) -- A new drug to fight osteoporosis, the bone condition associated with aging and debilitating fractures, reduces the risk of fractures and the risk of some breast cancers, heart disease and stroke, according to a new study.

But, like other anti-osteoporosis drugs already on the market, the drug -- called lasofoxifene -- also boosts the risk of blood clots, the researchers found. Lasofoxifene, proposed brand name Fablyn, is not yet approved by the U.S. Food and Drug Administration.

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Overall, lasofoxifene looks good, according to lead study author Dr. Steven Cummings, professor and director of the San Francisco Coordinating Center at the University of California San Francisco.

But Dr. Carolyn Becker, who wrote an editorial accompanying the study published in the Feb. 25 issue of the New England Journal of Medicine, is taking a wait-and-see approach. "It may turn out to be a dynamite drug, but it's not anything I would rush in to use as a clinician," she said. "There are too many unknowns."

For the study, Cummings and his team assigned 8,556 women who were aged 59 to 80 and had osteoporosis to take a daily dose of the drug (either 0.25 or 0.5 milligrams a day) or a placebo for five years. All had a bone mineral density T score of minus 2.5, considered osteoporosis.

The new drug is in a class of medications known as selective estrogen-receptor modulators (SERM), which act like estrogen in some tissues but anti-estrogen in other. "They act like estrogens when binding to bone cells and don't act like estrogen in the breast [thus not 'feeding' any cancers of the breast]," Cummings said.

Another SERM, already on the market, is raloxifene (Evista).

In the study, the researchers found that lasofoxifene "reduces the risk of all fractures (spinal and elsewhere), breast cancer, heart disease and stroke," Cummings said. "Breast cancer by more than half, nonspinal fractures by about a quarter, which is similar to what other drugs have done, stroke and heart disease by a quarter to a third."

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