Once-Yearly Drug Prevents Fractures
Reclast for Osteoporosis: One 15-Minute Infusion per Year
WebMD News Archive
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.