Regulator to approve new osteoporosis treatment

18th June 2010 - The National Institute for Health and Clinical Excellence (NICE) is recommending denosumab (Prolia) for women at increased risk of fractures if another treatment is not suitable for them.

Increased risk means a combination of low bone mineral density, age and other risk factors such as parental history of hip fracture, high alcohol intake and rheumatoid arthritis.

In draft guidance released today, NICE says postmenopausal women who are at increased risk of fractures linked to osteoporosis should be treated with denosumab if treatment with currently available oral bisphosphonates is unsuitable.

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

Most postmenopausal women at increased risk of osteoporotic fractures are treated with oral bisphosphonates but for some women these drugs may be unsuitable. Such reasons include being unable to comply with the special instructions for the oral medication - such as remaining standing or sitting upright for half an hour after taking them.

Dr Carole Longson, Health Technology Evaluation Centre Director at NICE says in a statement: “Our independent Appraisal Committee felt that there was good quality evidence to show that denosumab is a useful addition to the treatment options available to prevent a first fracture in women at increased risk and also at preventing further fractures in women who have already experienced one.

“We hope that older women at increased risk of osteoporotic fractures who cannot take oral bisphosphonates will be considered for this drug in order to help prevent the misery of breaking a bone, and we are now opening a consultation on this preliminary decision.”

This draft guidance has been issued for consultation. Until it becomes final, health departments will make decisions locally about funding the new treatment.