Novartis

13 May 2007

Switzerland-based drug major Novartis says that its drug Aclasta (zoledronic acid; sold as Reclast in the USA) cuts the risk of all types of bone fractures in women with postmenopausal osteoporosis. The findings, which are derived from a three-year Phase III trial, are published in the current issue of the New England Journal of Medicine.

The HORIZON study, which enrolled more than 7,700 women between the ages of 65 and 89, was designed to examine the drug's safety and efficacy when used to reduce the risk of bone fracture. Participants were randomized to receive a 5mg dose of the agent, or placebo, delivered via a once-yearly, 15 minute, 100ml infusion. Primary efficacy endpoints included the occurrence of new vertebral and hip fractures at three years, compared with placebo.

The results showed that Aclasta reduced the risk of spine and hip fractures compared with placebo, 71% and 41%, respectively, and that this effect was sustained throughout the study's three year duration. Novartis said that this demonstrates a significant advantage over oral bisphosphonates, which typically cut the likelihood of such fractures between 40% and 50%. In addition, Aclasta increased bone mineral density in the spine (6.7%), the hip (6.0%) and the femoral neck (5.1%) versus placebo, but did not affect bone turnover rates, which were normal throughout the assessment.

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