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Published on 2 October 2008

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Osteoporosis drug recieves EU approval

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Aclasta has been approved by the European Commsission for the treatment of osteoporosis in men, as well as to reduce the risk of new fractures following hip fracture in both men and postmenopausal women.

Aclasta – which is a product of pharmaceutical company Novartis – is the only osteoporosis treatment to show 28% reduction in all-cause mortality following a low-trauma hip fracture.

“Despite the severity and the large numbers affected, osteoporosis in men has received very little attention,” said Steven Boonen, Professor of Medicine at the Leuven University Centre for Metabolic Bone Diseases and Division of Geriatric Medicine in Belgium.

“Most people view osteoporosis solely as a ‘woman’s disease’, but this is not the case. It is vital that men with osteoporosis have the same efficacious treatment options available to them as women, and today’s announcement is therefore especially welcome.”

With an estimated one in five men over the age of 50 experiencing an osteoporotic fracture, it is an important health concern. In cases of hip fracture, the mortality rate is higher in men than in women in the year following the fracture. Over the first six months, men are approximately twice as likely to die as women of a similar age.

In 2000, approximately 1.6 million hip fractures occurred worldwide and in Europe the number of hip fractures was estimated at around 179,000 for men and 711,000 for women. The cost of all osteoporotic fractures was estimated to be 31.5 billion.

Norvartis



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