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By Sandra G. Boodman
Washington Post Staff Writer
Tuesday, January 1, 2002

U.S. Cases: 10 million, most of them women over 65

The advice for women – and men – seeking to prevent the fragile bone disease that often accompanies aging remains unchanged: daily consumption of at least 1,000 milligrams of calcium through diet (both dairy products and nondairy foods such as canned salmon and collard greens); supplements; and weight-bearing exercise such as walking or, better still, lifting weights.

For the millions for whom those measures prove insufficient, the tentative approval by the Food and Drug Administration (FDA) in October of Forteo (teriparatide), an injectible drug for osteoporosis, marked a promising turn. Forteo, a form of parathyroid hormone, has generated excitement as the first compound that stimulates new bone formation in addition to preventing fractures. But questions about the safety of the drug, not yet commercially available, continue to dog its manufacturer, Eli Lilly. One researcher involved in clinical trials of Forteo said negotiations between the FDA and the drug maker involve a possible warning label, prompted by a Lilly-sponsored study that found Forteo caused bone cancer in rats. Lilly has argued that lower doses given to people pose little risk.

That leaves Fosamax, also known as alendronate, as the leader of a quartet of approved osteoporosis drugs that blunt the loss of existing bone mass but do not build new bone. In 2000, the FDA approved a once-weekly Fosamax pill, which has proved popular with patients and has not caused an increase in side effects, doctors say.

Other promising drugs reportedly in the research pipeline include intravenous zoledronate, requiring a once-yearly 15-minute infusion. New York endocrinologist Felicia Cosman, medical director of the National Osteoporosis Foundation, said the drug, now entering the last phase of FDA clinical trials, appears to stay in the skeleton for months, retarding the loss of bone mass.

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