Denosumab

NICE technology appraisal guidance 204

October 2010

What is it?

• Human monoclonal antibody that inhibits osteoclast formation and function, so reduces bone resorption

• A treatment for the prevention of osteoporotic fractures in postmenopausal women

• Injection every 6 months (£183 = £1/day)

When to use it?Primary prevention: • only if combination of age, T-score and risk factors make it

appropriate • AND• Unable to tolerate alendronate, risedronate etc, or have

contraindication

Independent risk factors:• Parental history of hip fracture• 4 or more units alcohol per day• Rheumatoid disease

Age (years)

Number of independent clinical risk factors for fracture

0 1 2

65-69 - * -4.5 -4.070-74 -4.5 -4.0 -3.5>75 -4.0 -4.0 -3.0

*Treatment with denosumab is not recommended T-scores (SD) at (or below) which denosumab is recommended

When to use it (2)

Secondary prevention of osteoporotic fragility fractures:

• Postmenopausal women,

• at increased risk of fractures, and

• unable to tolerate alendronate, risedronate etc, (or have contraindication)