A new six-year data reinforces the long-term efficacy and safety profile of once-yearly Aclasta (also known as Reclast in the United States, with active ingredient of zoledronic acid 5 mg) in post-menopausal women suffering from osteoporosis.

In Toronto, Canada, a study of more than 1,200 women was presented by Novartis at the annual meeting of the American Society for Bone and Mineral Research (ASBMR).

The new study showed that Aclasta preserved bone mass in post-menopausal osteoporotic patients who received annual infusions of the drug for six years . Patients who stopped Aclasta treatment after three years showed decrease in the bone mineral density (BMD). However, in the latter, the BMD remained well above the levels measured at the start of the study with the difference between the two groups of participants at six years, at 1.04%, p=0.0009.

The study also showed that patients with six years Aclasta therapy experienced reduced risk of new morphometric spine fractures by 52%, as compared to those who had three years of treatment. Morphometric fractures can sometimes occur without pain and thus, may go undiagnosed and untreated. Patients can experience over time these fractures in the form of loss of height, back pain or stooped posture.

Dr. Dennis Black, the lead of author of the study, said: "These new findings show that continued treatment with zoledronic acid for six years continues to maintain bone mass and reduces vertebral fractures risk with no change to its favorable safety profile compared to discontinuation of treatment after three years."

Black said with the study's long-term data, it confirms Aclasta as a therapeutic option for doctors in considering osteoporosis medicine for their patients.

Black is a Professor of Epidemiology and Biostatistics at the University of California, San Francisco.

In the study, bone markers were maintained over 6- years in both study group within the normal premenopausal range. In patients with three years of Aclasta showed no evidence of accelerated bone loss. This apparently confirms that Aclasta helps preserve the balanced process by which the bone is constantly renewed and remodeled through out adult life (also called, bone turnover).

Novartis said that that these long-term data affirm the drug company's confidence in the efficacy ad safety profile of Aclasta.

Novartis Global Head of Development Dr. Trevor Mundel said: "Aclasta is highly effective at protecting patients against osteoporotic fractures for a long period of time and its once-yearly dosing represents an important improvement for patients and doctors in terms of compliance for an entire year."

Aclasta is the only annual treatment approved in United States and European Union to reduce the risk of fractures in areas of the body t affected by osteoporosis. Aclasta is also the only proven therapy to reduce new clinical fracture and all-cause mortality showing 28% reduction in death, after a recent low trauma hip fracture.

In more than 90 countries, Aclasta is approved for up to six indications to treat a broad spectrum of patients, from the newly diagnosed to those with more severe forms of osteoporosis.