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An annual infusion of a drug now used to treat cancer patients can boost bone density in healthy postmenopausal women just as well as medications that must be taken by mouth every day.
The drug, Zometa (zoledronic acid), was first approved to treat excessive amounts of calcium in the blood in cancer patients, and February 19th the US Food and Drug Administration (FDA) extended this approval to treatment of tumors that have spread to bone.
Zometa belongs to a class of drugs called bisphosphonates, which are used orally to treat osteoporosis. These drugs have drawbacks, the researchers note, including gastrointestinal intolerance and poor absorption by the gastrointestinal tract.
To investigate whether Zometa might be an effective osteoporosis treatment -- and sidestep the problems seen with oral drugs- researchers tested the drug in over 350 postmenopausal women with low bone mineral density.
According to the report, researchers observed increases in bone mineral density among all Zometa-treated patients for one year which were 5% higher than increases seen in the placebo-treated patients.
The increases in bone mineral density among Zometa-treated patients were comparable to increases experienced with daily doses of three other drugs: Actonel, Fosamax and Aredia.
The rates of adverse events were similar among all Zometa-treated patients. Among those treated with Zometa, the most common side effects were musculoskeletal pain, nausea and fever, most of which were reported as mild.
The maker of Zometa, Swiss drug giant Novartis, helped fund the study.
Osteoporosis has been regarded as requiring daily therapy, and maintaining compliance with daily regimens for a predominantly asymptomatic condition has been a major problem. Administration of treatment at intervals of 6 to 12 months or more is likely to be much more acceptable to patients.
The New England Journal of Medicine February 28, 2002;346:653-661
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