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11-10-2010 | Article

NICE gives osteoporosis drug green light

Abstract

National Institute for Health and Clinical Excellence: Final Draft Guidance on Osteoporotic Fractures – Denosumab

The biological therapy denosumab may be used to treat postmenopausal women at risk of osteoporotic fractures who cannot take oral bisphosphonates, the National Institute for Health and Clinical Excellence (NICE) has ruled.

Denosumab is given by subcutaneous injection twice a year and works by reducing bone breakdown and increasing bone mass and strength.

NICE is recommending the drug for both primary and secondary prevention - depending on a combination of age, T-score and number of risk factors - if a woman is unable to comply with or tolerate, or has a contraindication to, currently available oral bisphosphonates.

Spokesperson for the National Osteoporosis Society Dr Claire Bowring said that denosumab may avoid some of the common side effects, such as digestive problems, associated with oral bisphosphonates - and also has the potential to be administered by GPs, meaning it could cut down on hospital visits for some.

She added: "While more data is needed on the long-term use of denosumab to compare fully with current drugs, there is a clear benefit to patients in the ease of taking a twice-a-year treatment, rather than having to take pills every week, with a complex fasting regime."

NICE Health Technology Evaluation Centre Director, Dr Carole Longson said: "We believe that older women at increased risk of osteoporotic fractures who cannot take alendronate, and either risedronate or etidronate, should be considered for this drug alongside the other options available in order to help prevent the misery of breaking a bone."

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