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NICE approves denosumab for osteoporosis

Women at risk of osteoporotic fracture to be offered new drug

Louise Prime

Wednesday, 15 September 2010

Women who are at risk of sustaining an osteoporotic fracture and who can’t use oral bisphosphonates should be offered treatment with denosumab, according to today’s draft guidance from the National Institute for Health and Clinical Excellence (NICE).

The draft guidance says that postmenopausal women at increased risk of osteoporotic fragility fractures should be offered the monoclonal antibody denosumab (Prolia) if they are intolerant of, or have contraindications to, the currently available oral bisphosphonates alendronate, and either risedronate or etidronate; or if they can’t comply with the special instructions for using these drugs.

Denosumab is injected twice a year to reduce bone breakdown and increase bone mass; it is licensed to treat postmenopausal women who are at increased risk of osteoporotic fractures. NICE said denosumab could be used for both primary and secondary prevention in women who meet the specified criteria. It also said that women who do not meet those criteria but who are already taking the drug can continue it until they or their doctor decides to stop.

Dr Carole Longson, Health Technology Evaluation Centre director at NICE, said: “Our independent Appraisal Committee felt that there was good quality evidence to show that denosumab is a useful addition to the treatment options available for women who can't have oral bisphosphonates.

“It should help to prevent a first fracture in women at increased risk and also help prevent further fractures in women who have already experienced one.

“We believe that older women at increased risk of osteoporotic fractures who cannot take alendronate, and either risedronate and etidronate, should be considered for this drug alongside the other options available in order to help prevent the misery of breaking a bone.”

Appeals against the recommendations may be made via the NICE website until 29 September, and NICE expects to publish its final guidance later this year.


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