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First Osteoporosis Study in Hip Fracture Patients Finds Once-Yearly Reclast(R) Prevents Additional Fractures and Improves Survival
Date:9/17/2007

iovascular safety (including atrial fibrillation), found Reclast to be comparable with placebo. Incidence of renal events were similar between the Reclast and placebo group (6.2% versus 5.6%, respectively). Atrial fibrillation serious adverse events occurred in 1.1% of Reclast-treated patients compared to 1.3% of placebo- treated patients. No cases of osteonecrosis of the jaw (ONJ) were seen in the study. The most common adverse events with Reclast were transient post-dose symptoms (such as fever, muscular pain, etc).

About the Study

The Recurrent Fracture Trial was an international, multi-center, randomized, double-blind, placebo-controlled Phase III study designed to evaluate the efficacy and safety of Reclast in preventing subsequent fractures in men and women following the surgical repair of a low-trauma hip fracture (i.e., a fall from standing height or less or equivalent force).

It is part of the Novartis HORIZON clinical trial program, one of the most comprehensive drug evaluation programs ever undertaken in the area of metabolic bone diseases involving 13,000 patients in more than 400 centers worldwide.

Men and women between the ages of 50 and 98 who had experienced a recent hip fracture sustained with minimal trauma were randomized to receive a once- yearly infusion of Reclast or placebo within 90 days of undergoing surgery to repair the hip fracture and every 12 months thereafter for up to three years.

The primary endpoint of the study was to determine the effect of Reclast on new clinical fractures following baseline hip fracture. Secondary endpoints included the change in bone mineral density (BMD) in the non- fractured hip measured annually; spine, non-spine and hip fractures; and pre- specified safety endpoints, including death.

About Reclast

Reclast was approved by the US Food and Drug Administration (FDA) on August 17, 2007 as the first and only once-yearly treatment for postmenopausal osteoporosis. Approval
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SOURCE Novartis Pharmaceuticals Corporation
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