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Brief Summary

GUIDELINE TITLE

Bisphosphonates (alendronate, etidronate, risedronate), selective oestrogen receptor modulators (raloxifene) and parathyroid hormone (teriparatide) for the secondary prevention of osteoporotic fragility fractures in postmenopausal women.

BIBLIOGRAPHIC SOURCE(S)

  • 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 STATUS

This is the current release of the guideline.

BRIEF SUMMARY CONTENT

 
RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

 Go to the Complete Summary

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

This guidance covers the secondary prevention of osteoporotic fragility fractures in postmenopausal women who have sustained a clinically apparent osteoporotic fracture.

This guidance covers the treatment of postmenopausal women who have normal calcium levels and/or vitamin D levels. Unless clinicians are confident that women who receive osteoporosis treatment have an adequate calcium intake and are vitamin D replete, calcium and/or vitamin D supplementation should be provided.

This guidance does not cover the treatment of corticosteroid-induced osteoporosis.

  1. Bisphosphonates (alendronate, etidronate, and risedronate) are recommended as treatment options for the secondary prevention of osteoporotic fragility fractures:
    • In women aged 75 years and older, without the need for prior dual energy X-ray absorptiometry (DEXA) scanning
    • In women aged between 65 and 74 years if the presence of osteoporosis is confirmed by DEXA scanning
    • in postmenopausal women younger than 65 years of age, if they have a very low bone mineral density (BMD, that is with a T-score of approximately –3 standard deviations (SD) or below*, established by a DEXA scan), or if they have confirmed osteoporosis plus one, or more, additional age-independent risk factor: low body mass index (<19 kg/m2); family history of maternal hip fracture before the age of 75 years; untreated premature menopause; certain medical disorders independently associated with bone loss (such as chronic inflammatory bowel disease, rheumatoid arthritis, hyperthyroidism or coeliac disease); conditions associated with prolonged immobility.
  1. In their choice of bisphosphonate, clinicians and patients need to balance the drug's overall proven effectiveness profile against tolerability and adverse effects in individual patients.
  2. Raloxifene is recommended as an alternative treatment option, under the circumstances specified in Section 1 above, in women:
    • For whom bisphosphonates are contraindicated (see Summaries of Product Characteristics), or
    • Who are physically unable to comply with the special recommendations for use of bisphosphonates, or
    • Who have had an unsatisfactory response to bisphosphonates (as defined in Section 5 below), or
    • Who are intolerant of bisphosphonates (as defined in Section 6 below)
  1. Teriparatide is recommended as a treatment option for the secondary prevention of osteoporotic fragility fractures in women aged 65 years and older who have had an unsatisfactory response to bisphosphonates or intolerance to bisphosphonates (as defined in Sections 5 and 6 below, respectively), and:
    • Who have an extremely low BMD (with a T-score of approximately –4 SD or below), or
    • Who have a very low BMD (with a T-score of approximately –3 SD or below) plus multiple fractures (that is, more than two) plus one, or more, additional age-independent risk factor: low body mass index (<19 kg/m2); family history of maternal hip fracture before the age of 75 years; untreated premature menopause; conditions associated with prolonged immobility
  1. For the purpose of this guidance, an unsatisfactory response occurs when a woman has another fragility fracture despite adhering fully to treatment for 1 year and there is also evidence of a decline in BMD below her pre-treatment baseline.
  2. For the purpose of this guidance, intolerance of bisphosphonates is defined as oesophageal ulceration, erosion, or stricture, or severe lower gastrointestinal symptoms, any of which warrants discontinuation of treatment with a bisphosphonate.

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 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).

ADAPTATION

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

DATE RELEASED

2005 Jan

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: Dr Jane Adam, Radiologist, St George's Hospital, London; Dr Sunil Angris, General Practitioner, Waterhouses Medical Practice, Staffordshire; Dr Darren Ashcroft, Senior Clinical Lecturer, School of Pharmacy and Pharmaceutical sciences, University of Manchester; Professor David Barnett, Professor of Clinical Pharmacology, University of Leicester; Dr Peter Barry, Consultant in Paediatric Intensive Care and Honorary Senior Lecturer, Department of Child Health, Leicester Royal Infirmary; Professor John Brazier, Health Economist, University of Sheffield; Mr Brian Buckley, Lay representative, Vice Chairman, InContact; Professor John Cairns, Professor of Health Economics, Health Economics Research Unit, University of Aberdeen; Professor Mike Campbell, Statistician, Institute of General Practice & Primary Care, Sheffield; Dr Peter I Clark, Consultant Medical Oncologist, Clatterbridge Centre for Oncology, Wirral, Merseyside; Mr Richard Devereaux-Phillips, Public Affairs Manager, Medtronic Ltd; Professor Cam Donaldson, PPP Foundation Professor of Health Economics, School of Population and Health Sciences and Business School – Economics, University of Newcastle upon Tyne; Professor Jack Dowie, Health Economist, London School of Hygiene; Dr Paul Ewings, Statistician, Taunton & Somerset NHS Trust, Taunton; Professor Gary A Ford (Vice-Chair) Professor of Pharmacology of Old Age and Consultant Physician, Newcastle upon Tyne Hospitals NHS Trust; Dr Fergus Gleeson, Consultant Radiologist, The Churchill Hospital, Oxford; Ms Sally Gooch, Director of Nursing, Mid-Essex Hospital Services NHS Trust, Chelmsford; Professor Trisha Greenhalgh, Professor of Primary Health Care, University College London; Miss Linda Hands, Clinical Reader in Surgery, University of Oxford; Professor Peter Jones, Professor of Statistics and Dean, Faculty of Natural Sciences, Keele University; Professor Robert Kerwin, Professor of Psychiatry and Clinical Pharmacology, Institute of Psychiatry, London; Ms Joy Leavesley, Senior Clinical Governance Manager, Guy's and St Thomas' NHS Trust; Ms Ruth Lesirge, Previously Director, Mental Health Foundation, London; Dr George Levvy, Chief Executive, Motor Neurone Disease Association, Northampton; Ms Rachel Lewis, Staff Nurse (Nephrology) Hull Royal Infirmary; Dr Ruairidh Milne, Senior Lecturer in Public Health, National Coordinating Centre for Health Technology Assessment, University of Southampton; Dr Neil Milner, General Medical Practitioner, Sheffield; Dr Rubin Minhas, General Practitioner with a Special Interest in Coronary Heart Disease, Primary Care CHD Lead, Medway PCT and Swale PCT; Dr Gill Morgan, Chief Executive, NHS Confederation, London; Professor Philip Routledge, Professor of Clinical Pharmacology, College of Medicine, University of Wales, Cardiff; Dr Stephen Saltissi, Consultant Cardiologist, Royal Liverpool University Hospital; Mr Miles Scott, Chief Executive, Harrogate Health Care NHS Trust; Professor Mark Sculpher, Professor of Health Economics, University of York; Mr Malcolm Stamp, Chief Executive, Addenbrooke's NHS Trust; Dr Ken Stein, Senior Lecturer, Peninsula Technology Assessment Group (PenTAG), University of Exeter; Professor Andrew Stevens (Chair) Professor of Public Health, University of Birmingham; Dr Norman Waugh, Department of Public Health, University of Aberdeen

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.

GUIDELINE AVAILABILITY

AVAILABILITY OF COMPANION DOCUMENTS

The following is available:

Print copies: Available from the National Health Service (NHS) Response Line 0870 1555 455. ref: N0786. 11 Strand, London, WC2N 5HR.

Additionally, Audit Criteria can be found in Appendix C of the original guideline document.

PATIENT RESOURCES

The following is available:

  • Bisphosphonates (alendronate, etidronate, risedronate), raloxifene and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women. Understanding NICE guidance – information for women with postmenopausal osteoporosis who have had a fracture as a result of the disease, their families and carers, and the public. London (UK): National Institute for Health and Clinical Excellence (NICE); 2005 Jan. 124 p. (Technology appraisal 87).

Electronic copies: Available in English and Welsh in Portable Document Format (PDF) from the National Institute for Health and Clinical Excellence (NICE) Web site.

Print copies: Available from the NHS Response Line 0870 1555 455. ref: N0787. 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.

NGC STATUS

COPYRIGHT STATEMENT

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DISCLAIMER

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