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Primary and secondary prevention of osteoporotic fragility fractures in postmenopausal women 2008 Implementing NICE guidance NICE technology appraisal.

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Presentation on theme: "Primary and secondary prevention of osteoporotic fragility fractures in postmenopausal women 2008 Implementing NICE guidance NICE technology appraisal."— Presentation transcript:

1 Primary and secondary prevention of osteoporotic fragility fractures in postmenopausal women 2008 Implementing NICE guidance NICE technology appraisal guidance 160 and 161

2 Definitions and scope Background Recommendations Costs and savings Discussion Find out more What this presentation covers

3 NICE reviews each piece of guidance it issues. TA161 replaces NICE technology appraisal guidance 87 issued in January 2005. The review and re-appraisal of alendronate, etidronate, risedronate, raloxifene and teriparatide for secondary prevention of osteoporotic fragility fractures has resulted in changes in the criteria for offering these drugs. In addition, strontium ranelate has also been appraised. Note: updated guidance

4 BMD: bone mineral density DXA: dual-energy X-ray absorptiometry Fragility fracture: a low-trauma fracture T-score: the number of standard deviations (SD) below the mean BMD of young adults at their peak bone mass Osteoporosis: a T-score of −2.5 (SD) or below on DXA scanning Definitions

5 For the purposes of this guidance: Primary prevention refers to opportunistic identification, during visits to a healthcare professional for any reason, of postmenopausal women who are at risk of osteoporotic fragility fractures and who could benefit from drug treatment. It does not imply a dedicated screening programme. Secondary prevention relates only to treatments for the secondary prevention of fragility fractures in postmenopausal women who have osteoporosis and have sustained a clinically apparent osteoporotic fragility fracture. Scope

6 In England and Wales, it is estimated that: over 2 million women have osteoporosis 180,000 osteoporosis-related fractures occur annually 1 in 3 women over 50 years of age will sustain a vertebral fracture 2 million bed days annually are a result of fractures annual social and hospital care costs £1.8 billion Background

7 Fragility fractures are the clinically apparent outcome of osteoporosis. In the absence of fracture, osteoporosis is asymptomatic. Hip fractures are associated with increased mortality. 50–70% of vertebral fractures do not come to clinical attention. Clinical need

8 Risk factors and risk assessment Independent clinical risk factors for fracture: parental history of hip fracture alcohol intake of 4 or more units per day rheumatoid arthritis. Indicators of low bone mineral density: low body mass index below 22 kg/m 2 ankylosing spondylitis Crohn’s disease conditions resulting in prolonged immobility untreated premature menopause.

9 Technologies Alendronate, etidronate, risedronate (bisphosphonates) inhibitors of bone resporption and increase BMD by altering osteoclast activation and function. Raloxifene (selective oestrogen receptor modulator) SERMs have selective activity in various organ systems, acting as either a weak oestrogen-receptor agonist or antagonist. Strontium ranelate an element with properties similar to calcium with a dual effect on bone metabolism, increasing formation and decreasing resorption. Teriparatide (parathyroid hormone) a recombinant fragment of human parathyroid hormone which stimulates new formation of bone and increases resistance to fracture.

10 Contraindications Compliance with special instructions for administration Intolerance Bisphosphonates (alendronate, etidronate, risedronate) – persistent upper gastrointestinal disturbance that is sufficiently severe to warrant discontinuation of treatment, where instructions for administration have been followed correctly Strontium ranelate – persistent nausea or diarrhoea, which warrants discontinuation of treatment Adherence to treatment

11 Postmenopausal women aged Independent clinical risk factor for fracture Indicator of low BMD Osteoporosis confirmed younger than 65 years 1 or more andat least one additional indicator Required 65–69 years1 or moren/aRequired 70 years and older1 or more orYesRequired In women ≥ 75 years: not required if two or more clinical risk factors or indicators of low BMD Initial treatment offered: alendronate Primary prevention: first treatment option

12 Primary prevention: alternative treatment option (1) Number of independent clinical risk factors for fracture Age (years)012 65–69 a −3.5−3.0 70–74−3.5−3.0−2.5 75 or older−3.0 −2.5 a Treatment with risedronate or etidronate is not recommended. Alternative treatment – risedronate or etidronate when women: are unable to comply with administration of, or have a contraindication to or are intolerant of alendronate and have a combination of T-score, age and number of clinical risk factors as outlined in the table.

13 Primary prevention: alternative treatment option (2) Number of independent clinical risk factors for fracture Age (years)012 65–69 a −4.5−4.0 70–74−4.5−4.0−3.5 75 or older−4.0 −3.0 a Treatment with strontium ranelate is not recommended. Alternative treatment – strontium ranelate when women: are unable to comply with administration of, or have a contraindication to or are intolerant of alendronate and either risedronate or etidronate and have a combination of T-score, age and number of clinical risk factors as outlined in the table.

14 Initial treatment offered: alendronate Postmenopausal women with confirmed osteoporosis A DXA scan may not be required in women aged 75 or over Secondary prevention: first treatment option

15 Secondary prevention: alternative treatment option (1) Number of independent clinical risk factors for fracture Age (years)012 50–54 a −3.0−2.5 55–59−3.0 −2.5 60–64−3.0 −2.5 65–69−3.0−2.5 70 or older−2.5 a Treatment with risedronate or etidronate is not recommended. Alternative treatment – risedronate or etidronate when women: are unable to comply with administration of, or have a contraindication to or are intolerant of alendronate and have a combination of T-score, age and number of clinical risk factors as outlined in the table.

16 Secondary prevention: alternative treatment option (2) Number of independent clinical risk factors for fracture Age (years)012 50–54 a −3.5 55–59−4.0−3.5 60–64−4.0−3.5 65–69−4.0−3.5−3.0 70–74−3.0 −2.5 75 or older−3.0−2.5 a Treatment with raloxifene or strontium ranelate is not recommended. Alternative treatment – strontium ranelate or raloxifene when women: are unable to comply with administration of, or have a contraindication to or are intolerant of alendronate and either risedronate or etidronate and have a combination of T-score, age and number of clinical risk factors as outlined in the table.

17 Secondary prevention: alternative treatment option (3) Age (years)T-scoreFractures > 65 years−4.0 SD or below– > 65 years−3.5 SD or belowMore than two 55–64 years−4 SD or belowMore than two Alternative treatment – teriparatide when women: are unable to take, have a contraindication to or are intolerant of alendronate and either risedronate or etidronate, or have a contraindication to, or are intolerant of strontium ranelate or have had an unsatisfactory response to treatment with alendronate, risedronate or etidronate and have a combination of T-score, age and number of fractures as outlined in the table.

18 Women currently receiving treatment that is not recommended in this guidance should have the option to continue treatment. It is assumed women who receive treatment have an adequate calcium intake and are vitamin D replete – consider supplements if needed. Clinical management

19 Costs and savings Primary and secondary prevention per 100,000 population Primary prevention Costs and savings (£ per year) Estimated cost of implementation 6,642 Estimated savings from implementation 6,816 Secondary prevention Costs and savings (£ per year) Estimated costs of implementation30,733 Estimated savings from implementation 9,206

20 How/or will current local prescribing arrangements need to change as a result of this guidance? How can we increase adherence to therapy? What arrangements currently exist regarding access to DXA scanning for this patient group? How can we improve links between primary and secondary care to improve the care of women with osteoporosis? For discussion

21 Visit www.nice.org.uk/TA160 and www.nice.org.uk/TA161 for:www.nice.org.uk/TA160www.nice.org.uk/TA161 Other guidance formats Costing report and template Audit support Find out more


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