Annual Infusion of Reclast Approved to Treat Osteoporosis
Single dose per year protects against fractures
THURSDAY, Aug. 23 (HealthDay News) -- The U.S. Food and Drug Administration has approved Reclast (zoledronic acid) to treat postmenopausal osteoporosis, according to the manufacturer, Novartis. The drug, which had previously been approved to treat Paget's disease, is administered in a single, annual dose as a 15-minute intravenous infusion.
Approval was granted on the basis of data from the three-year Pivotal Fracture Trial involving 7,700 women, which showed that Reclast reduced fractures across all key areas.
Hip fractures were reduced by 41 percent and spine fractures were reduced by 60 percent, 71 percent and 70 percent in years one, two and three, respectively. There was also a 6.7 percent increase in bone mineral density in the spine compared with results for subjects given placebo.
"Osteoporosis is a serious disease affecting millions of people in this country," said Leo Schargorodski, executive director of the National Osteoporosis Foundation, in a statement issued by Novartis. "[The foundation] welcomes new FDA-approved treatment options, such as Reclast, that give patients a choice when it comes to taking their osteoporosis therapy."