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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

for postmenopausal osteoporosis was based on the results of the Pivotal Fracture Trial, which involved more than 7,700 women. In the study, published in The New England Journal of Medicine in May 2007, Reclast was shown to increase bone strength and reduce fractures in areas of the body typically affected by osteoporosis, including the hip, spine and non- spine (i.e., hip, wrist, arm, leg, rib). Reclast is the only treatment approved to reduce the risk of fractures across all of these key sites. The study showed Reclast reduced the risk of spine fractures by 70% and hip fractures by 41% (4).

Reclast belongs to a class of drugs called bisphosphonates, which are used to treat osteoporosis, the most common metabolic bone disease affecting more than 10 million people in the US (2). Unlike oral bisphosphonate treatments, where patients take daily, weekly or monthly doses of medication, Reclast is given as a once-yearly infusion.

In July 2007, the Committee for Medicinal Products for Human Use (CHMP) also issued a positive opinion recommending approval in the European Union, under the brand name Aclasta(R). The European Commission generally follows the CHMP's recommendations and is expected to issue a final decision within three months.

Reclast is approved in more than 60 countries, including the US, Canada and the EU for the treatment of Paget's disease of the bone, the second most common metabolic bone disorder. Additional studies are ongoing to examine the use of Reclast to treat corticosteroid-induced osteoporosis, male osteoporosis and bone loss in postmenopausal women with osteopenia.

The active ingredient in Reclast is zoledronic acid, which is also available in a different dosage under the brand name Zometa(R) (zoledronic acid 4 mg) Injection for use in certain oncology indications.

Reclast is contraindicated in patients with hypocalcemia (low blood calcium) and those who are allergic to zoledronic acid. Reclast contains the same acti
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SOURCE Novartis Pharmaceuticals Corporation
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