Primary and secondary prevention of osteoporotic fragility fractures in postmenopausal women

2008

Implementing NICE guidance

NICE technology appraisal guidance 160 and 161

Definitions and scope

Background

Recommendations

Costs and savings

Discussion

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What this presentation covers

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 alsobeen appraised.

Note: updated guidance

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

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

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

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

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/m2 • ankylosing spondylitis• Crohn’s disease • conditions resulting in prolonged immobility • untreated premature menopause.

Technologies

Alendronate, etidronate, risedronate (bisphosphonates)inhibitors of bone resporption and increase BMD by alteringosteoclast activation and function.

Raloxifene (selective oestrogen receptor modulator)SERMs have selective activity in various organ systems, acting aseither a weak oestrogen-receptor agonist or antagonist.

Strontium ranelatean element with properties similar to calcium with a dual effecton bone metabolism, increasing formation and decreasing resorption.

Teriparatide (parathyroid hormone)a recombinant fragment of human parathyroid hormonewhich stimulates new formation of bone and increasesresistance to fracture.

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

Postmenopausal women aged

Independent clinical risk factor for fracture

Indicator of low BMD

Osteoporosis confirmed

younger than65 years

1 or more and at least oneadditional indicator

Required

65–69 years 1 or more n/a Required

70 years and older 1 or more or Yes Required

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

Primary prevention: alternative treatment option (1)

Number of independent clinical risk factors for fracture

Age (years) 0 1 2

65–69 a −3.5 −3.0

70–74 −3.5 −3.0 −2.5

75 or older −3.0 −3.0 −2.5a 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.

Primary prevention: alternative treatment option (2)

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 −3.0a 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.

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

Secondary prevention: alternative treatment option (1)

Number of independent clinical risk factors for fracture

Age (years) 0 1 2

50–54 a −3.0 −2.5

55–59 −3.0 −3.0 −2.5

60–64 −3.0 −3.0 −2.5

65–69 −3.0 −2.5 −2.5

70 or older −2.5 −2.5 −2.5a Treatment with risedronate or etidronate is not recommended.

Alternative treatment – risedronate or etidronate when women:

• are unable to comply with administration of, or havea 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.

Secondary prevention: alternative treatment option (2)

Number of independent clinical risk factors for fracture

Age (years) 0 1 2

50–54 a −3.5 −3.5

55–59 −4.0 −3.5 −3.5

60–64 −4.0 −3.5 −3.5

65–69 −4.0 −3.5 −3.0

70–74 −3.0 −3.0 −2.5

75 or older −3.0 −2.5 −2.5a 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 havea 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.

Secondary prevention: alternative treatment option (3)

Age (years) T-score Fractures

> 65 years −4.0 SD or below –

> 65 years −3.5 SD or below More than two

55–64 years −4 SD or below More 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.

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

Costs and savings Primary and secondary prevention

per 100,000 population

Primary preventionCosts and savings

(£ per year)

Estimated cost of implementation 6,642

Estimated savings from implementation 6,816

Secondary preventionCosts and savings

(£ per year)

Estimated costs of implementation 30,733

Estimated savings from implementation 9,206

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

Visit www.nice.org.uk/TA160and www.nice.org.uk/TA161 for:

•Other guidance formats•Costing report and template•Audit support

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