NICE approves denosumab for postmenopausal fracture prevention

27 October 2010

Postmenopausal women at risk of fractures can now be treated with denosumab (Prolia) on the NHS.

Given as a subcutaneous injection twice a year, denosumab inhibits the RANK ligand – a key regulator of bone-resorbing osteoclasts.

NICE has recommended denosumab as an option for the primary and secondary prevention of osteoporotic fragility fractures in postmenopausal women for whom the recommended bisphosphonates are unsuitable.

Specifically, eligible patients must:

be unable to comply with the administration instructions for alendronate and either risedronate or etidronate, or
have an intolerance of, or a contraindication to, these treatments.

In addition, the guidance states that the antibody should be used for primary prevention only when the woman’s T-score is at or below the following values:

No. of independent clinical risk factors for fracture*
Age (years)	0	1	2
65-69	Not recommended	-4.5	-4.0
70-74	-4.5	-4.0	-3.5
75 or older	-4.0	-4.0	-3.0

*Parental history of hip fracture, alcohol intake of 4 or more units per day, rheumatoid arthritis.

People already receiving denosumab for the prevention of osteoporotic fractures who do not meet the above criteria should be able to continue treatment until they and their doctor decide it is appropriate to stop, says NICE.

NICE guidance on denosumab