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Long-Term Data Show Novartis Once-Yearly Reclast Preserves Bone Mass and Provides Fracture Protection in Postmenopausal Osteoporosis
Date:10/16/2010

ence of accelerated bone loss.(1) This builds upon existing data from extensive clinical studies and confirms that Reclast helps preserve bone turnover, the balanced process by which the bone is constantly renewed and remodeled throughout adult life.

"Reclast 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," said Trevor Mundel, MD, Global Head of Development at Novartis AG. "These long-term data affirm our confidence in the efficacy and safety profile of this medicine."

Osteoporosis is a condition in which bones become weak and break more easily.(4)  According to the National Osteoporosis Foundation (NOF), approximately 10 million people(4) in the US are affected by this disease, which caused approximately 547,000 vertebral fractures in the US in 2005.(4)

This long-term study, which extended the HORIZON (Health Outcomes and Reduced Incidence with Zoledronic Acid Once Yearly) Pivotal Fracture Trial by three years, is a multi-center, double-blind, randomized, placebo-controlled study to evaluate the long-term efficacy and safety of Reclast in the treatment of postmenopausal osteoporosis.(1) The extension study evaluated more than 1,200 women aged 68 years or older.(1) After three years of therapy, participants were randomized to either receive a Reclast infusion (n=616) or an annual placebo infusion (n=617) for an additional three years.(1)

The primary endpoint of the study was the percentage change in the BMD at the femoral neck at year six vs. year three.(1) Secondary endpoints included evaluation of BMD at other sites, fractures, changes in bone turnover markers and overall safety.(1) The incidence of adverse events was comparable between groups.(1) There was no long-term effect on renal function or increase in risk of osteonecrosis of the jaw or atria
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SOURCE Novartis Pharmaceuticals Corporation
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