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Osteoporosis drug set for approval


A drug intended to be given to patients just once a year has been recommended for European Union approval to treat osteoporosis in men who are at increased risk of fractures.

The Committee for Medicinal Products for Human Use has also recommended broadening the label to include data showing that Aclasta (zoledronic acid 5mg) reduces the risk of new clinical fractures by 35% in men and in postmenopausal women who have recently had a low-trauma hip fracture. Aclasta is the only osteoporosis treatment to demonstrate this benefit.

“This positive opinion is an encouraging step forward for the treatment of osteoporosis in both men and women,” said Steven Boonen, Professor of Medicine at the Leuven University Centre for Metabolic Bone Diseases and Division of Geriatric Medicine in Belgium.

“Osteoporosis in men has received little attention despite the large numbers affected. When fractures occur in men, they are associated with even higher morbidity and death than in women.”

He added: “For both men and women, hip fracture can be a potentially life-threatening consequence of osteoporosis, but unfortunately at present only a few people who experience hip fractures are treated for osteoporosis.”

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Committee for Medicinal Products for Human Use

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