A yearly 15-minute infusion of a new drug substantially reduces bone fractures in post-menopausal women, offering a new treatment option for women who have trouble taking existing bone-strengthening drugs, researchers report today.
Although drugs such as Fosamax and Actonel are effective at preventing bone loss and reducing the major health risks associated with fractures, as many as half of women stop taking them within six months because of the complicated regimen required and the risk of side effects.
The new drug, called zoledronic acid, “requires an encounter with the medical establishment only once a year, so there is no problem with compliance and adherence,” said Dr. Robert Recker of the Creighton University School of Medicine in Nebraska.
The drug also avoids the esophageal problems that are common with the oral drugs, said Recker, who is vice president of the National Osteoporosis Foundation and was not involved in the study.
The three-year study of 7,736 post-menopausal women found a 70 percent reduction in the risk of spinal fractures and a 40 percent reduction in the risk of hip fractures. “But even more remarkable were the strong, significant and consistent effects across all fracture types,” said epidemiologist Dennis Black of the University of California, San Francisco School of Medicine, who led the study.
The results were “impressive,” wrote Dr. Juliet Compston of the University of Cambridge School of Clinical Medicine in Britain in an editorial accompanying the report in the New England Journal of Medicine.
The drug already is sold by drug maker Novartis in the United States under the brand name Zometa for the treatment of Paget’s disease – a genetic disorder in which bone becomes soft and breaks down readily – and the prevention of bone loss in cancer chemotherapy.
The company is applying to the Food and Drug Administration to sell it under the name Reclast for treatment of osteoporosis.
About 10 million people in the United States suffer from osteoporosis, and another 34 million have low-bone density, which puts them at risk for the disorder, according to the osteoporosis foundation.
One out of every two women over the age of 50 will suffer a broken bone, and many of those can be quite serious. Among women over 65, for example, one out of every five who suffer a broken hip will die within a year from complications.