Raloxifene and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women

Technology appraisal guidance
Reference number: TA161
Published: 27 October 2008
Last updated: 07 February 2018

1 Recommendations

This guidance 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. 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 SDs from peak BMD). However, the diagnosis may be assumed in women aged 75 years or older if the responsible clinician considers a DXA scan to be clinically inappropriate or unfeasible.

This guidance assumes 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.

This guidance does not cover the following:

The use of raloxifene or teriparatide for the secondary prevention of osteoporotic fragility fractures in women with normal bone mineral density (BMD) or osteopenia (that is, women with a T-score between -1 and -2.5 SD below peak BMD).
The use of these drugs for the secondary prevention of osteoporotic fragility fractures in women who are on long-term systemic corticosteroid treatment.

1.1

This recommendation has been replaced by the recommendations in the NICE technology appraisal guidance on bisphosphonates for treating osteoporosis.

1.2

This recommendation has been replaced by the recommendations in the NICE technology appraisal guidance on bisphosphonates for treating osteoporosis.

1.3

The recommendation for strontium ranelate has been withdrawn because strontium ranelate is no longer marketed in the UK. Raloxifene is recommended as an alternative treatment option for the secondary prevention of osteoporotic fragility fractures in postmenopausal women:

who are unable to comply with the special instructions for the administration of alendronate and risedronate, or have a contraindication to or are intolerant of alendronate and risedronate (as defined in section 1.6) and
who also have a combination of T-score, age and number of independent clinical risk factors for fracture (see section 1.5) as indicated in the following table.

**Table 1 T-scores (SD) at (or below) which raloxifene is recommended when alendronate and risedronate cannot be taken**
Age	T-score for 0 independent clinical risk factors for fracture	T-score for 1 independent clinical risk factor for fracture	T-score for 2 independent clinical risk factors for fracture
50 to 54 years	Treatment with raloxifene is not recommended	-3.5	-3.5
55 to 59 years	-4.0	-3.5	-3.5
60 to 64 years	-4.0	-3.5	-3.5
65 to 69 years	-4.0	-3.5	-3.0
70 to 74 years	-3.0	-3.0	-2.5
75 years or older	-3.0	-2.5	-2.5

If a woman aged 75 years or older who has 1 or more independent clinical risk factors for fracture or indicators of low BMD has not previously had her BMD measured, a DXA scan may not be required if the responsible clinician considers it to be clinically inappropriate or unfeasible.

For the purposes of this guidance, indicators of low BMD are low body mass index (defined as less than 22 kg/m²), medical conditions such as ankylosing spondylitis, Crohn's disease, conditions that result in prolonged immobility, and untreated premature menopause. Rheumatoid arthritis is also a medical condition indicative of low BMD.

1.4

Teriparatide is recommended as an alternative treatment option for the secondary prevention of osteoporotic fragility fractures in postmenopausal women:

who are unable to take alendronate and risedronate, or have a contraindication to or are intolerant of alendronate and risedronate (as defined in section 1.6), or who have had an unsatisfactory response (as defined in section 1.8) to treatment with alendronate or risedronate and
who are 65 years or older and have a T-score of -4.0 SD or below, or a T-score of -3.5 SD or below plus more than 2 fractures, or who are aged 55 to 64 years and have a T-score of -4 SD or below plus more than 2 fractures.

1.5

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 year, and rheumatoid arthritis.

1.6

For the purposes of this guidance, intolerance of alendronate or risedronate is defined as persistent upper gastrointestinal disturbance that is sufficiently severe to warrant discontinuation of treatment, and that occurs even though the instructions for administration have been followed correctly.

1.7

The recommendation for strontium ranelate has been withdrawn because strontium ranelate is no longer marketed in the UK.

1.8

For the purposes of this guidance, an unsatisfactory response is defined as occurring when a woman has another fragility fracture despite adhering fully to treatment for 1 year and there is evidence of a decline in BMD below her pre-treatment baseline.

1.9

Women who are currently receiving treatment with 1 of the drugs covered by this guidance, but for whom treatment would not have been recommended according to sections 1.1 to 1.4, should have the option to continue treatment until they and their clinicians consider it appropriate to stop.