Once-Yearly Osteoporosis Drug Aclasta Reduces Bone Fractures

Filed in archive Drugs, Vaccines and Therapeutics on September 25, 2006

Phase III clinical trials demonstrate that a once-yearly infusion of Aclasta (zoledronic acid 5 mg solution for infusion) was highly effective in reducing the incidence of bone fracture in women with postmenopausal osteoporosis.

An interim analysis encompassing 99% of data from the now-completed three-year HORIZON Pivotal Fracture Trial showed that patients taking Aclasta experienced a 70% risk reduction in new spine fractures (p<0.0001) and a 40% risk reduction in hip fractures (p=0.0032) over three years compared to placebo.

These results were presented during the recently concluded 28th Annual meeting of the American Society for Bone and Mineral Research (ASBMR).

Aclasta has been approved in approximately 50 countries , including the EU and Canada, for the treatment of Paget's disease. The FDA issued an "approvable letter" for this product, under the proposed trade name Reclast, for the treatment of Paget's disease of the bone in February 2006. Zoledronic acid, the active ingredient of Aclasta, is also available under the brand name Zometa for use in other indications.

Source: Novartis