Study shows once-yearly Aclasta better than risedronate

New data show that a once-yearly infusion of Aclasta (zoledronic acid 5 mg) was significantly better than risedronate at increasing bone mass in patients with osteoporosis caused by glucocorticoids, commonly known as steroids. These medications are widely used to treat inflammatory conditions but can cause bone loss and osteoporosis.

Up to 50 per cent of patients receiving long-term glucocorticoid therapy are at increased risk of fracture due to osteoporosis, and approximately nine million people worldwide are affected by glucocorticoid-induced osteoporosis (GIO).

Results of a clinical study in 833 men and women were presented at the European Congress on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ECCEO) in Istanbul, Turkey.

"Recognizing and treating GIO is an important need, as glucocorticoid therapy is so widely used and presents an ongoing challenge for physicians," said Professor David M. Reid, head of the division of applied medicine at the University of Aberdeen, UK. "The significant efficacy of this once-yearly treatment, offering year-long bone protection, will provide a very valuable treatment option for healthcare professionals treating and managing osteoporosis induced by glucocorticoids".

The trial investigated both prevention (288 patients) and treatment (545 patients) of GIO. Results demonstrated that a single yearly infusion of Aclasta significantly increased bone mineral density (BMD) in the lumbar spine at 12 months compared to risedronate in both the treatment group.

Risedronate is one of the established treatments for GIO and, like Aclasta, is a member of the bisphosphonate class of drugs. Risedronate is taken in the form of a daily pill, whereas Aclasta is given as a once-yearly 15-minute infusion, promoting compliance with bisphosphonate treatment and providing annual protection against the consequences of osteoporosis.

Novartis is applying for an indication with the European Medicines Agency (EMEA) and the US Food and Drug Administration (FDA) for the treatment and prevention of GIO.