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New osteoporosis treatment approved for use in the UK

Amgen announced recently that Prolia (denosumab), a new type of osteoporosis treatment for post-menopausal women, has been granted marketing authorization in the UK.

Denosumab is a fully human monoclonal antibody that has been specifically designed to target RANK ligand, an essential regulator of osteoclast formation, function and survival in the bones. This increases bone density, significantly reducing the risk of vertebral, non-vertebral and hip fractures in post-menopausal women.

In a clinical trial involving 7800 patients, denosumab reduced the relative risk of new vertebral fractures by 68%, non-vertebral fractures by 20% and hip fractures by 40% (absolute risk reduction 4.8%, 1.5% and 0.3%, respectively). There are an estimated 230,000 osteoporosis-related fractures every year in the UK, 70,000 of which are hip fractures.

The impact of hip fracture can be devastating: 20% of patients suffering hip fracture die within four months, and more than 50% of those who survive a hip fracture are no longer able to live independently. The cost of osteoporotic hip fractures to the NHS is estimated at £2 billion a year.

Prolia is a six-monthly subcutaneous injection that can be given at a GP surgery. Commenting on the approval of Prolia, Dr Alun Cooper, a GP in Crawley, West Sussex, stated: ‘Fractures related to osteoporosis are common and can have a significant impact on my patients’ daily lives. Denosumab is a convenient and simple, six-monthly injection that can be administered in my surgery and, for me, is a promising development in the management of this disease’.

Further reading

Cummings, S.R. et al. (2009) Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N. Engl. J. Med. 361, 756–765

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