Once-Yearly Drug Prevents Fractures
Reclast for Osteoporosis: One 15-Minute Infusion per Year
Women tolerated the annual 15-minute infusions very well. After the infusion, about 14% of patients had some symptoms of what doctors call an acute phase reaction. They felt as though they had a mild viral infection, with low-grade fever, muscle and joint aches, and/or headache. In no case did this last longer than three days, Cosman says.
Women who took Reclast also had a significantly higher rate of serious atrial fibrillation -- a dangerous, abnormal heart rhythm. This happened to 50 of the 3,889 women who received the drug.
Black, Cosman, and colleagues report their findings in the May 3 issue of the New England Journal of Medicine. An editorial by Juliet Compston, MD, professor of bone medicine at the University of Cambridge, England, accompanies the study.
Compston says that Reclast will be appropriate for any woman whose bone density puts her at high risk of fracture.
"We have an exciting new option which is at least as effective as other options in reducing fractures," Compston tells WebMD. "It has something which many will see as an advantage: It has to be taken only once a year -- although the intravenous infusion will be a consideration for some. It is a new first-line treatment for osteoporosis."
The FDA currently approves Reclast for the treatment of Paget's disease, a metabolic bone disorder. Novartis Pharmaceutical's application to approve Reclast for postmenopausal osteoporosis is currently under FDA review. Novartis funded the Black study.