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FDA Approves Reclast(R) to Prevent Osteoporosis in Postmenopausal Women With Convenient Less Frequent Dosing
Date:5/31/2009

- Single infusion of Reclast increases bone mass for two years in postmenopausal women with osteopenia, a condition that can lead to osteoporosis(1)

- Approximately 22 million women in US have osteopenia, or low bone mass, putting them at increased risk of fractures of hip, spine and wrist(2,3)

- Reclast already approved as once-yearly infusion for treatment of postmenopausal osteoporosis(1)

EAST HANOVER, N.J., June 1 /PRNewswire/ -- Reclast(R) (zoledronic acid) Injection has been approved by the US Food and Drug Administration (FDA) as the first and only therapy to prevent postmenopausal osteoporosis for two years with a single dose(1). Reclast is already approved as a once-yearly infusion for the treatment of postmenopausal osteoporosis(1).

The FDA decision is based on a study involving more than 500 postmenopausal women with osteopenia, or low bone mass, showing that a single infusion of Reclast significantly increased bone mineral density (BMD) at two years compared to placebo(1).

Approximately 22 million women in the US have osteopenia, putting them at increased risk of osteoporosis, a disease that causes bones to break more easily(2,3). Osteoporosis is a major public health threat affecting an estimated 10 million men and women in the US(2).

Although low bone mass is less severe in people with osteopenia than those with osteoporosis, they are still at increased risk of fractures(4). In fact, research shows that approximately half of women who experience a fragility fracture, or a broken bone due to a fall from standing height or less, have osteopenia(5,6,7,8), highlighting the importance of treating and preventing further bone loss.

"It is very important to treat postmenopausal women with low bone mass to help prevent them from progressing to osteoporosis," said Mone Zaidi, MD, PhD, Professor of Medicine, Geriat
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SOURCE Novartis Pharmaceuticals Corporation
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