NICE technology appraisal guidance
Issued: October 2010
TA204

Denosumab for the prevention of osteoporotic fractures in postmenopausal women

This is an extract from the guidance. The complete guidance is available at guidance.nice.org.uk/ta204

1 Guidance

1.1 Denosumab is recommended as a treatment option for the primary prevention of osteoporotic fragility fractures only in postmenopausal women at increased risk of fractures:

  • who are unable to comply with the special instructions for administering alendronate and either risedronate or etidronate, or have an intolerance of, or a contraindication to, those treatments and

  • who have a combination of T-score[1], age and number of independent clinical risk factors for fracture (see section 1.3) as indicated in the following table.

T-scores (SD) at (or below) which denosumab is recommended when alendronate and either risedronate or etidronate are unsuitable

Number of independent clinical risk factors for fracture

Age (years)

0

1

2

65-69

[a]

−4.5

−4.0

70-74

−4.5

−4.0

−3.5

75 or older

−4.0

−4.0

−3.0

[a] Treatment with denosumab is not recommended.

1.2 Denosumab is recommended as a treatment option for the secondary prevention of osteoporotic fragility fractures only in postmenopausal women at increased risk of fractures who are unable to comply with the special instructions for administering alendronate and either risedronate or etidronate, or have an intolerance of, or a contraindication to, those treatments.

1.3 For the purposes of this guidance, independent clinical risk factors for fracture are parental history of hip fracture, alcohol intake of 4 or more units per day, and rheumatoid arthritis.

1.4 People currently receiving denosumab for the primary or secondary prevention of osteoporotic fragility fractures who do not meet the criteria specified in recommendations 1.1 or 1.2 should have the option to continue treatment until they and their clinician consider it appropriate to stop.



[1] T-score measures bone mineral density using central (hip and/or spine) dual-energy X-ray (DXA) scanning, and is expressed as the number of standard deviations (SD) below peak bone mineral density.