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Brief Summary

GUIDELINE TITLE

Alendronate, etidronate, risedronate, raloxifene, strontium ranelate and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women.

BIBLIOGRAPHIC SOURCE(S)

  • National Institute for Health and Clinical Excellence (NICE). Alendronate, etidronate, risedronate, raloxifene, strontium ranelate and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women. London (UK): National Institute for Health and Clinical Excellence (NICE); 2008 Oct. 67 p. (Technology appraisal guidance; no. 161).

GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: National Institute for Clinical Excellence (NICE). Bisphosphonates (alendronate, etidronate, risedronate), selective oestrogen receptor modulators (raloxifene) and parathyroid hormone (teriparatide) for the secondary prevention of osteoporotic fragility fractures in postmenopausal women. London (UK): National Institute for Clinical Excellence (NICE); 2005 Jan. 51 p. (Technology appraisal; no. 87).

BRIEF SUMMARY CONTENT

 
RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

 Go to the Complete Summary

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

Note from the National Institute for Health and Clinical Excellence (NICE): This guidance 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.

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-score* 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.

NICE is developing a clinical guideline on 'Osteoporosis: assessment of fracture risk and the prevention of osteoporotic fractures in individuals at high risk' (see www.nice.org.uk). This technology appraisal guidance should be read in the context of the clinical guideline when it is available.

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.

  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. 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 below) and
    • Who also have a combination of T-score*, age and number of independent clinical risk factors for fracture (see below) 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
    Age (years) 0 1 2
    50-54 Treatment not recommended -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

    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. 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 below) and
    • Who also have a combination of T-score*, age and number of independent clinical risk factors for fracture (see below) 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
    Age (years) 0 1 2
    50-54 Treatment not recommended -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

    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 menopause**.

    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.

  1. 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 below), or who have a contraindication to, or are intolerant of strontium ranelate (see below), or who have had an unsatisfactory response (as defined below) 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 to 64 years and have a T-score* of –4 SD or below plus more than two fractures.
  1. 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.
  2. 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.
  3. For the purposes of this guidance, intolerance of strontium ranelate is defined as persistent nausea or diarrhoea, either of which warrants discontinuation of treatment.
  4. 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.
  5. 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 above, should have the option to continue treatment until they and their clinicians consider it appropriate to stop.

    *T-score relates to the measurement of BMD using central (hip and/or spine) DXA scanning, and is expressed as the number of SD from peak BMD.

    **Rheumatoid arthritis is also a medical condition indicative of low BMD.

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of evidence supporting the recommendations is not specifically stated.

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

  • National Institute for Health and Clinical Excellence (NICE). Alendronate, etidronate, risedronate, raloxifene, strontium ranelate and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women. London (UK): National Institute for Health and Clinical Excellence (NICE); 2008 Oct. 67 p. (Technology appraisal guidance; no. 161).

ADAPTATION

Not applicable: The guideline was not adapted from another source.

DATE RELEASED

2005 Jan (revised 2008 Oct)

GUIDELINE DEVELOPER(S)

National Institute for Health and Clinical Excellence (NICE) - National Government Agency [Non-U.S.]

SOURCE(S) OF FUNDING

National Institute for Health and Clinical Excellence (NICE)

GUIDELINE COMMITTEE

Appraisal Committee

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Committee Members: Professor Keith Abrams (2006–2008), Professor of Medical Statistics, University of Leicester; Ms Julie Acred (2004–2005), Chief Executive, Derby Hospitals NHS Foundation Trust; Dr Ray Armstrong (2008), Consultant Rheumatologist, Southampton General Hospital; Dr Jeff Aronson (2006–2008), Reader in Clinical Pharmacology, University Department of Primary Health Care, University of Oxford; Dr Darren Ashcroft (2004–2008), Senior Clinical Lecturer, School of Pharmacy and Pharmaceutical Sciences, University of Manchester; Professor David Barnett (2004–2008), Professor of Clinical Pharmacology, University of Leicester; Dr Peter Barry (2004–2008), Consultant in Paediatric Intensive Care, Leicester Royal Infirmary; Professor Stirling Bryan (2006–2008), Head, Department of Health Economics, University of Birmingham; Mr Brian Buckley (2004–2006), Vice Chairman, InContact; Professor John Cairns (2006–2008), Public Health and Policy, London School of Hygiene and Tropical Medicine; Professor David Chadwick (2005–2006), Professor of Neurology, Walton Centre for Neurology and Neurosurgery; Dr Peter I Clark (2004–2006), Honorary Chairman, Association of Cancer Physicians; Ms Donna Covey (2004–2005), Chief Executive, Asthma UK; Dr Mike Davies (2004–2008), Consultant Physician, University Department of Medicine and Metabolism, Manchester Royal Infirmary; Mr Richard Devereaux-Phillips (2004–2006), Public Affairs Manager, Medtronic Ltd; Professor Jack Dowie (2004–2008), Health Economist, London School of Hygiene and Tropical Medicine; Professor Trisha Greenhalgh (2004–2005), Professor of Primary Health Care, University College London; Lynn Field (2006–2008), Nurse Director, Pan Birmingham Cancer Network; Professor Gary A Ford (2004–2005), Professor of Pharmacology of Old Age/Consultant Physician, Royal Victoria Infirmary, Newcastle upon Tyne; Professor Christopher Fowler (2006–2008), Professor of Surgical Education, Barts and The London School of Medicine and Dentistry, Queen Mary, University of London; Dr Fergus Gleeson (2004–2008), Consultant Radiologist, Churchill Hospital, Oxford; Ms Sally Gooch (2004–2008), Independent Nursing and Healthcare Consultant; Mrs Barbara Greggains (2006–2008), Lay member; Mr Sanjay Gupta (2005–2008), Former Service Manager in Stroke, Gastroenterology, Diabetes and Endocrinology, Basildon and Thurrock University Hospitals Foundation NHS Trust; Ms Linda Hands (2004–2005), Consultant Vascular Surgeon, John Radcliffe Hospital, Oxford; Professor Philip Home (2005–2006), Professor of Diabetes Medicine, University of Newcastle upon Tyne; Dr Peter Jackson (2005–2006), Clinical Pharmacologist, University of Sheffield; Professor Peter Jones (2004–2006), Professor of Statistics and Dean Faculty of Natural Science, Keele University; Professor Robert Kerwin (2004–2005), Professor of Psychiatry and Clinical Pharmacology, Institute of Psychiatry, London; Dr Mike Laker (2005–2007), Medical Director, Newcastle Hospitals NHS Trust; Ms Joy Leavesley (2004), Senior Clinical Governance Manager, Whittington Hospital; Dr Ruth Lesirge (2004), Lay member; Ms Rachel Lewis (2004–2006), Nurse Adviser to the Department of Health; Mr Terence Lewis (2006–2008), Lay member; Dr George Levvy (2005–2006), Lay member; Professor Gary McVeigh (2006–2008), Professor of Cardiovascular Medicine, Queens University, Belfast; Professor Jonathan Michaels (2004–2006), Professor of Vascular Surgery, University of Sheffield; Dr Ruairidh Milne (2004–2008), Senior Lecturer in Health Technology Assessment, National Coordinating Centre for Health Technology, University of Southampton; Dr Neil Milner (2004–2008), General Practitioner, Tramways Medical Centre, Sheffield; Dr Rubin Minhas (2004–2008), General Practitioner, CHD Clinical Lead, Medway PCT; Dr John Pounsford (2006–2008), Consultant Physician, Frenchay Hospital, Bristol; Dr Rosalind Ramsay (2006–2008), Consultant Psychiatrist, Adult Mental Health Services, Maudsley Hospital, London; Dr Christa Roberts (2006–2008), UK Country Manager, Abbott Vascular; Dr Stephen Saltissi (2006–2008), Consultant Cardiologist, Royal Liverpool University Hospital; Mr Miles Scott (2004–2006), Chief Executive, Bradford Teaching Hospitals NHS Foundation Trust; Dr Lindsay Smith (2005–2008), General Practitioner, East Somerset Research Consortium; Mr Roderick Smith (2006–2008), Finance Director, West Kent PCT; Mr Cliff Snelling (2006–2008), Lay member; Mr Malcolm Stamp (2004), Chief Executive, Addenbrookes NHS Trust; Professor Ken Stein (2004–2008), Professor of Public Health, Peninsula College of Medicine and Dentistry, University of Exeter; Professor Andrew Stevens (Chair) (2004–2008), Professor of Public Health, University of Birmingham; Dr Rod Taylor (2006–2008), Associate Professor in Health Services Research, Peninsula Medical School, Universities of Exeter and Plymouth

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Committee members are asked to declare any interests in the technology to be appraised. If it is considered there is a conflict of interest, the member is excluded from participating further in that appraisal.

GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: National Institute for Clinical Excellence (NICE). Bisphosphonates (alendronate, etidronate, risedronate), selective oestrogen receptor modulators (raloxifene) and parathyroid hormone (teriparatide) for the secondary prevention of osteoporotic fragility fractures in postmenopausal women. London (UK): National Institute for Clinical Excellence (NICE); 2005 Jan. 51 p. (Technology appraisal; no. 87).

GUIDELINE AVAILABILITY

AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

Print copies: Available from the National Health Service (NHS) Response Line 0870 1555 455. ref: N1725. 11 Strand, London, WC2N 5HR.

PATIENT RESOURCES

The following is available:

Print copies: Available from the NHS Response Line 0870 1555 455. ref: N1726. 11 Strand, London, WC2N 5HR.

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

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