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Novartis says Aclasta better at boosting bone mass
Apr 14, 08 Clinical Updates Medical Product Safety AlertsNovartis AG’s Aclasta was more effective than Procter & Gamble Co’s Actonel in increasing bone mass in patients with the bone-thinning disease osteoporosis, a study showed.
A once-yearly infusion of Aclasta showed benefits versus the daily pill Actonel, also known as risedronate, in patients taking steroids, which are widely used to treat inflammatory conditions but can cause bone loss and osteoporosis, Novartis said.
The results, from a study of 833 men and women, were presented on Friday at the European Congress on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis in Istanbul.
Data also confirmed Aclasta, which is approved for use in the United States and Europe, was comparable to Actonel in important safety issues, including kidney impairment and delayed healing of fractures, and was generally safe and well tolerated, Novartis said.
U.S. regulators have warned that patients treated with a widely used class of osteoporosis drugs known as bisphosphonates, including Aclasta and Actonel, may develop severe and sometimes disabling pain in muscles, joints and bones.
The Food and Drug Administration is currently conducting a review of the class of drugs, which also includes Merck & Co Inc’s Fosamax and Boniva from Roche Holding AG and GlaxoSmithKline Plc.
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