( d with significant mortality (2) was r...)Once-yearly Reclast Significantly Reduced Bone Fractures in Women,with Postmenopausal Osteoporosis,Health

"We believe Reclast is an innovative treatment approach for the millions of women with osteoporosis and provides impressive fracture reduction, the primary goal of osteoporosis treatment," said James Shannon, MD, Global Head of Development at Novartis Pharma AG.

About the Pivotal Fracture Trial

The Pivotal Fracture Trial was a Phase III, multi-center, randomized, placebo-controlled study examining the efficacy and safety of Reclast in reducing the risk of bone fracture in women with postmenopausal osteoporosis. The study enrolled more than 7,700 women between the ages of 65 and 89 with postmenopausal osteoporosis in 27 countries. The primary endpoints of the study were new spine and hip fractures over three years compared to placebo. Secondary endpoints included reducing the incidence of non-spine fractures, evaluation of bone mineral density (BMD), normalization of bone turnover markers, and overall safety.

In addition to reductions in spine and hip fractures, the study also demonstrated that Reclast significantly reduced the risk of non-spine, all clinical, and clinical spine fractures by 25 percent, 33 percent and 77 percent respectively.

Bone mineral density increased significantly in the spine by 6.7 percent and the hip by 6 percent in women on Reclast compared to placebo.

In the study, overall incidence of adverse events experienced with Reclast was comparable to placebo. The most common post-dose adverse events with Reclast were fever, muscle pain, flu-like symptoms, headache, and joint pain, most of which occurred within the first three days following Reclast administration. The majority of these symptoms resolved within three days of the event onset. The incidence decreased markedly with subsequent an
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