Data to be published in this weeks issue of The New England Journal of Medicine show that a once-yearly treatment significantly reduced the incidence of all types of osteoporotic bone fractures over three years in women with postmenopausal osteoporosis. The publication marks the first time that an osteoporosis treatment significantly reduced all types of fractures in a single study.
The Phase III clinical study involved more than 7,700 women between the ages of 65 and 89 in 27 countries. All women involved in the study had postmenopausal osteoporosis and received Reclast (zoledronic acid) Injection or placebo. Results from the study show that Reclast reduced the frequency of fractures among the areas of the body that are typically affected by osteoporosis, including the hip, spine, and wrist. Specifically, a 70 percent reduction was achieved in spine fractures. The risk of hip fractures, which are associated with significant mortality, was reduced by 41 percent.
The study also showed bone mineral density increased significantly in the spine by 6.7 percent and in the hip by 6 percent in women on Reclast compared to those who received placebo.
Reclast belongs to a class of drugs called bisphosphonates, which are used to treat osteoporosis. Unlike other bisphosphonate treatments that require women to take daily, weekly, or monthly doses for postmenopausal osteoporosis, Reclast is given as a once-yearly 15-minute infusion.
Osteoporosis affects more than 10 million people in the U.S. An estimated one out of two women over age 50 will suffer an osteoporosis-related fracture in her lifetime.
The FDA is currently reviewing Reclast for the treatment of postmenopausal osteoporosis. The FDA has approved the drug for the treatment of Pagets disease of bone, the second most common metabolic bone disorder after osteoporosis.