Technology Appraisal Guidance No. 204
Source: National Institute for Health and Care Excellence
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-score1, age and number of independent clinical risk factors for fracture (see section 1.3) as indicated in the following table.
|Age (years)||Number of independent clinical risk factors for fracture|
|75 or older||−4.0
|aTreatment with denosumab is not recommended|
1T-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.
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.
The guidance shown above constitutes Section 1 of the full document. A copy of the full document and a summary of the evidence is available on the Internet at http://guidance.nice.org.uk/TA204
An abridged version of this guidance (a 'quick reference guide') is also available. Printed copies of the quick reference guide can be obtained by contacting 0845 003 7783 or emailing firstname.lastname@example.org and quoting reference number N2338. It is also available on the Internet at http://guidance.nice.org.uk/TA204/QuickRefGuide/pdf/English
This guidance represents the view of the Institute which was arrived at after careful consideration of the available evidence. Health professionals are expected to fully take it into account when exercising their clinical judgement. This guidance does not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
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Denosumab for the prevention of osteoporotic fractures in postmenopausal women.
Issue Date: October 2010