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Title: Once-yearly Zoledronic Acid Approved in EU to Treat Osteoporosis in Men
URL: http://www.pslgroup.com/dg/22DD9E.htm
Doctor's Guide
September 30, 2008

NEW YORK -- September 30, 2008 -- The European Commission has approved once-yearly zoledronic acid (Aclasta) 5 mg for the treatment of osteoporosis in men who are at increased risk of fractures. The label has also been revised to include reduction of new clinical fractures in both men and postmenopausal women with osteoporosis who have recently suffered a hip fracture.

"Despite the severity and the large numbers affected, osteoporosis in men has received very little attention," said Steven Boonen, Division of Geriatric Medicine, Leuven University Centre for Metabolic Bone Diseases, Leuven, Belgium.

"Most people view osteoporosis solely as a 'woman's disease', but this is not the case. It is vital that men with osteoporosis have the same efficacious treatment options available to them as women, and today's announcement is therefore especially welcome."

In addition, the EU label has been extended to include data from the landmark Recurrent Fracture Trial, involving more than 2,100 patients, showing that once-yearly zoledronic acid reduced the risk of new clinical fractures by 35% in men and postmenopausal women who recently had a low-trauma hip fracture.

The new label also includes data from the same study showing that all-cause mortality was significantly reduced by 28% in the zoledronic acid -treated group compared with those receiving placebo (101 vs. 141 deaths)

"For both men and women, hip fracture can be a potentially life-threatening consequence of osteoporosis," said Boonen. "Hip fracture is associated with a high risk of morbidity and mortality, and it is encouraging that we now have a treatment proven to reduce the risk of a new fracture after this has occurred."

The most common adverse events associated with zoledronic acid were transient post-dose symptoms such as fever and muscle pain. Most of these symptoms occurred within the first 3 days following administration and resolved within 3 days.

SOURCE: Novartis

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