Aclasta Gets Approval In EU To Treat Osteoporosis

Published: 26-Jun-2009

Osteoporosis caused by long-term use of glucocorticoids, commonly known as steroids

Aclasta (zoledronic acid 5 mg) has been approved in the European Union (EU) to treat men and postmenopausal women with osteoporosis. It is caused by long-term use of glucocorticoids, commonly known as steroids.

The new indication for men and women with glucocorticoid-induced osteoporosis (GIO) is based on study data showing that Aclasta, given once a year as a 15-minute infusion, is more effective at treating bone loss than daily oral risedronate.

The latest approval was based on a study of 833 men and women, which investigated both the prevention and treatment of GIO. The study had several advantages over previous trials, studying the effects of bisphosphonate drugs on GIO.

David Reid, Head of Applied Medicine at the University of Aberdeen, said: Oral bisphosphonates have been used for many years for the treatment of GIO, but they are associated with poor compliance as patients frequently fail to take them as prescribed. Available data show that patients who remember to take their medicines only half of the time receive little or no protection.

The approval of Aclasta is a significant step forward, as it is more effective and faster-acting than a current established therapy for the treatment of GIO and has the advantage of year-long compliance and sustained osteoprotection, he added.

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