March 19, 2009
Reclast approved for steroid-induced osteoporosisThe FDA has approved once-yearly Reclast (zoledronic acid, from Novartis) injection, a bisphosphonate, for the treatment and prevention of osteoporosis caused by glucocorticoids for patients expected to be on glucocorticoids for at least 12 months.
This approval is based on data from a multinational, double-blind, head-to-head study comparing Reclast to an established therapy. The study involved 833 men and women who were on high-dose glucocorticoid therapy for more than 3 months (treatment group) or less than 3 months (prevention group) before the start of the study and who were expected to stay on the therapy for at least 12 months. Results showed that Reclast increased bone mineral density (BMD) significantly more than the active control in both the treatment and prevention groups.
Reclast is already approved for the treatment of postmenopausal osteoporosis; to reduce the incidence of new clinical fractures in patients at high risk of fractures; and Paget's disease of bone (men and women).
For more information call (866) RECLAST or visit www.reclast.com.