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NICE has published two technology appraisals on the use of drugs for the primary and secondary prevention of osteoporotic fragility fractures in postmenopausal women with osteoporosis. Healthcare professionals and others involved in the management of osteoporosis should familiarise themselves with the recommendations made by NICE. The development of the NICE osteoporosis guideline is currently being reviewed.
Background
These technology appraisals recommend a range of treatment options, based on cost effectiveness, for primary and secondary prevention of osteoporosis, including options for women who cannot comply with the recommended first-line treatment, or who have contra-indications to, or intolerance of, that treatment. A combination of T-score, age and number of independent clinical risk factors is specified within the appraisals for each alternative treatment option. These should be considered when assessing a woman’s suitability for an alternative treatment option.
In the NICE appraisals, osteoporosis is defined by a T-score of −2.5 standard deviations (SD) or below on dual-energy X-ray absorptiometry (DXA) scanning. T-score relates to the measurement of bone mineral density (BMD) using central (hip and/or spine) DXA scanning, and is expressed as the number of standard deviations (SD) from peak BMD.
For the purposes of NICE appraisals, independent clinical risk factors for fracture are parental history of hip fracture, alcohol intake of 4 or more units per day, and rheumatoid arthritis. Indicators of low BMD are low body mass index (defined a less than 22 kg/m2), medical conditions such as ankylosing spondylitis, Crohn’s disease, conditions that result in prolonged immobility, and untreated premature menopause.
Both of the NICE technology appraisals assume that women who receive treatment have an adequate calcium intake and are vitamin D replete. Unless clinicians are confident that women who receive treatment meet these criteria, calcium and/or vitamin D supplementation should be considered.
NICE is also developing a clinical guideline on ‘Osteoporosis: assessment of fracture risk and the prevention of osteoporotic fractures in individuals at high risk’. The development of this is currently being reviewed following the publication of the technology appraisals.
What is recommended for primary prevention?
Alendronate is recommended as the first-line treatment for primary prevention of osteoporotic fragility fractures in women aged 70 years or older who have:
- an independent clinical risk factor for fracture or
- an indicator of low bone mineral density (BMD) and
- who are confirmed to have osteoporosis.
In women aged 75 years or older who have two or more independent risk factors for fracture or low BMD, a DXA scan may not be required if the responsible clinician considers it to be clinically inappropriate or unfeasible.
Alendronate is also recommended for primary prevention of osteoporotic fragility fractures in women younger than 70 years who have confirmed osteoporosis, plus an independent clinical risk factor for fracture for those aged 65–69 years, plus at least one additional indicator of low BMD in women younger than 65. The preparation with the lowest acquisition cost should be used.
Risedronate and etidronate are recommended alternatives for women who
- are unable to comply with alendronate treatment or
- have a contraindication to, or are intolerant of, alendronate and
- have a specified combination of T-score, age and number of independent clinical risk factors for fracture.
Strontium ranelate▼ is a recommended alternative treatment if alendronate, risedronate and etidronate are unsuitable, based on a specified combination of T-score, age and number of independent clinical risk factors. Raloxifene is not recommended as a treatment option.
What is recommended for secondary prevention?
Alendronate is recommended for the secondary prevention of osteoporotic fragility fractures in postmenopausal women who have confirmed osteoporosis. Women aged 75 years or older may not need a DXA scan if their doctor considers a DXA scan to be clinically inappropriate or unfeasible.
For women who are unsuitable for alendronate (unable to comply with treatment, or if contraindicated or intolerant), risedronate and etidronate are recommended options based on a specified combination of age, T-score and number of independent clinical risk factors for fracture.
Strontium ranelate▼ and raloxifene are recommended alternatives if alendronate, risedronate and etidronate are unsuitable, based on a specified combination of age, T-score and number of independent clinical risk factors.
This appraisal also specifies criteria for when teriparatide▼ may be used by those women who are unable to take, or have an unsatisfactory response to the above options, based on age, T-score, and number of previous fractures.
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