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.

Aclasta is already approved in more than 50 countries for the treatment of postmenopausal osteoporosis and in more than 70 countries for the treatment of Paget's disease of bone, the second most common metabolic bone disorder. Additional indications for Aclasta are being pursued worldwide for the prevention of clinical fractures after hip fracture and the treatment of osteoporosis in men.

A growing body of clinical evidence supports Aclasta as the only treatment for postmenopausal osteoporosis approved in the US and EU to reduce the risk of fractures in all key sites typically affected by osteoporosis, including the hip, spine and non-spine (e.g. wrist and rib).

"These new data reinforce the efficacy of this novel once-yearly treatment and confirm Aclasta's ability to increase bone mineral density significantly in different populations," said Trevor Mundel, MD, head of global development functions at Novartis Pharma AG. "We already know from previous osteoporosis studies that patients prefer a single yearly dose versus oral weekly treatment, confirming that Aclasta should provide a real benefit for patients affected by osteoporosis".

The primary objective of the GIO study was to demonstrate non-inferiority of Aclasta to risedronate in percentage change in lumbar spine BMD from baseline at 12 months. Secondary endpoints included change in lumbar spine BMD at six months, and in the BMD of femoral neck and total hip at six and 12 months.

Results from the study confirm that Aclasta is generally safe and well-tolerated. The most common adverse events associated with Aclasta were transient post-dose symptoms such as fever and muscle pain. The majority of these symptoms occurred in the first three days after Aclasta administration and resolved within three days. Post-dose symptoms can be reduced by taking paracetamol or ibuprofen shortly after the Aclasta infusion.

The active ingredient in Aclasta is zoledronic acid, which is also available in a different dosage under the brand name Zometa (zoledronic acid 4 mg) for use in certain oncology indications.