Technology Appraisal Guidance No. 161
Source: National Institute for Health and Clinical Excellence
1. Guidance
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-score1 of -2.5 standard deviations (SD) or lower on dual-energy X-ray absorptiometry (DXA) scanning. 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 alendronate, etidronate, risedronate, raloxifene, strontium ranelate 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.
These groups will be covered within future guidance produced by the Institute.
1T-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.
1.1 Alendronate is recommended as a treatment option for the secondary prevention of osteoporotic fragility fractures in postmenopausal women who are confirmed to have osteoporosis (that is, a T-score of -2.5 SD or below). In women aged 75 years or older, a DXA scan may not be required if the responsible clinician considers it to be clinically inappropriate or unfeasible. When the decision has been made to initiate treatment with alendronate, the preparation prescribed should be chosen on the basis of the lowest acquisition cost available.
1.2 Risedronate and etidronate are recommended as alternative treatment options 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, or have a contraindication to or are intolerant of alendronate (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.
| T-scores (SD) at (or below) which risedronate or etidronate is recommended when alendronate cannot be taken | |||
| Number of independent clinical risk factors for fracture (see section 1.5) | |||
| 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 | -2.5 |
| aTreatment with risedronate or etidronate is not recommended | |||
If a women aged 75 years or older 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.
In deciding between risedronate and etidronate, clinicians and patients need to balance the overall proven effectiveness profile of the drugs against their tolerability and adverse effects in individual patients.
1.3 Strontium ranelate and raloxifene are recommended as alternative treatment options 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 either risedronate or etidronate, or have a contraindication to or are intolerant of alendronate and either risedronate or etidronate (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.
| T-scores (SD) at (or below) which strontium ranelate or raloxifene is recommended when alendronate and either risedronate or etidronate cannot be taken | |||
| Number of independent clinical risk factors for fracture (see section 1.5) | |||
| 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 | -2.5 |
| aTreatment with raloxifene or strontium ranelate is not recommended. | |||
If a woman aged 75 years or older who has one 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 menopause2.
In deciding between strontium ranelate and raloxifene, clinicians and patients need to balance the overall proven effectiveness profile of these drugs against their tolerability and other effects in individual patients.
2Rheumatoid 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 either risedronate or etidronate, or have a contraindication to or are intolerant of alendronate and either risedronate or etidronate (as defined in section 1.6), or who have a contraindication to, or are intolerant of strontium ranelate (as defined in section 1.7), or who have had an unsatisfactory response (as defined in section 1.8) to treatment with alendronate, risedronate or etidronate 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 two fractures, or who are aged 55-64 years and have a T-score of -4 SD or below plus more than two 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 day, and rheumatoid arthritis.
1.6 For the purposes of this guidance, intolerance of alendronate, risedronate or etidronate 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 For the purposes of this guidance, intolerance of strontium ranelate is defined as persistent nausea or diarrhoea, either of which warrants discontinuation of treatment.
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 one 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.
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/TA161
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 publications@nice.org.uk and quoting reference number N1725. It is also available on the Internet at http://www.nice.org.uk/Guidance/TA161/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.
© Copyright National Institute for Health and Clinical Excellence. All rights reserved. This material may be freely reproduced for educational and not for profit purposes within the NHS. No reproduction by or for commercial organisations is permitted without the express written permission of the Institute.
Enquiries concerning the guidance should be addressed to: National Institute for Health and Clinical Excellence, MidCity Place, 71 High Holborn, London WC1V 6NA. email: nice@nice.nhs.uk
Alendronate, Etidronate, Risedronate, Raloxifene, Strontium Ranelate and Teriparatide for the Secondary Prevention of Osteoporotic Fragility Fractures in Postmenopausal Women (Amended).
Issue Date: October 2008 (amended January 2010 and January 2011)
Review Date:
