Guideline:
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
Note: This guideline has been updated. The National Guideline Clearinghouse (NGC) is working to update this summary.
Guideline Category
Assessment of Therapeutic Effectiveness
Management
Prevention
Treatment
Intended Users
Advanced Practice Nurses
Physician Assistants
Physicians
Guideline Objective(s)
To review the clinical and cost-effectiveness of selective oestrogen receptor modulators (SERMs) bisphosphonates and parathyroid hormone (PTH) (subject to licensing) for the prevention and treatment of osteoporosis and the prevention of osteoporotic fractures in post-menopausal women
Target Population
Postmenopausal women with osteoporosis who have normal calcium levels and/or vitamin D levels and who have already sustained at least one fracture as a result of the disease
Note: This guidance does not include women with corticosteroid-induced osteoporosis.
Interventions and Practices Considered
- Bisphosphonates (alendronate etidronate risedronate)
- Selective oestrogen receptor modulators (SERMs) (raloxifene)
- Parathyroid hormone (teriparatide)
Major Outcomes Considered
- Clinical effectiveness
- Vertebral or nonvertebral fracture
- Quality of life
- Associated effects (both adverse and beneficial)
- Continuance and compliance
- Cost effectiveness
Methods Used to Collect/Select Evidence
Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases
Description of Methods used to Collect/Select the Evidence
Note from the National Guideline Clearinghouse (NGC): The National Institute for Health and Clinical Excellence (NICE) commissioned an independent academic centre to perform a systematic literature review on the technology considered in this appraisal and prepare an assessment report. The assessment report for this technology appraisal was prepared by The University of Sheffield School of Health and Related Research [ScHARR]. (See the "Availability of Companion Documents" field.)
Clinical Effectiveness
Search Strategy
Because of the range of interventions and comparators under review the literature search aimed to identify all literature relating to the prevention and treatment of osteoporosis. The main searches were conducted in May and July 2002 and updated in September and October 2002. The utilities searches were performed in October and November 2002.
Sources Searched
Fourteen electronic bibliographic databases were searched covering biomedical science social science health economic and grey literature. A list of the databases searched is provided in Appendix 2 of the Assessment Report (see "Availability of Companion Documents" field).
In addition the reference lists of relevant articles and sponsor submissions were handsearched and various health services research-related resources were consulted via the Internet. These resources included health economics and health technology assessment (HTA) organisations guideline-producing agencies registers of generic research and trials and specialist sites. These additional sources are listed in Appendix 3 of the Assessment Report (see "Availability of Companion Documents" field).
Search Terms
A combination of free-text and thesaurus terms was used. General "population" search terms (e.g. osteoporosis bone density diseases fracture etc) were used in order to identify all potentially relevant studies. "Intervention" terms were not used in the main searches since it was felt that these might restrict the results and cause possibly relevant articles to be missed. Utilities searches were performed for breast cancer and for osteoporosis fractures as part of the economic evaluation section of the report. Copies of the Medline search strategies are included in Appendix 4 of the Assessment Report (see "Availability of Companion Documents" field). Search strategies for the other databases are available on request.
Search Restrictions
No language date or study-type restrictions were applied to the searches. However the Biosciences Information Service (BIOSIS) search was performed as title only and the Citation Indexes searches were limited with brief clinical trials systematic reviews guidelines and economics filters and to title only in order to keep the number of hits to a sensible level. An randomized controlled trial (RCT) filter an economics and quality of life evaluations filter and a systematic reviews filter were used in the main searches performed in Medline and Embase to assist the identification of articles of these types (see Appendix 5 of the Assessment Report [see "Availability of Companion Documents" field]). After the searches were completed because of the large number of references retrieved only the articles identified using these specific filters the articles from the databases that were not searched with filters (such as BIOSIS) and the papers found through handsearching etc were reviewed.
Inclusion and Exclusion Criteria
Inclusion Criteria
Participants: Women with primary osteoporosis who were at least 6 months postmenopausal
Interventions:
- Bisphosphonates
- Alendronate
- Etidronate
- Risedronate
- Selective oestrogen receptor modulators (SERMs)
- Raloxifene
- Teriparatide (recombinant human parathyroid hormone (1-34))
Comparators:
- Vitamin D
- Calcitriol (a vitamin 1alpha-hydroxylated derivative)
- Pharmacological doses of calcium
- Oestrogens (opposed and unopposed)
- Exercise
- Placebo
- No treatment
Outcome Measures: Vertebral or nonvertebral fracture associated effects quality of life related to the study intervention continuance and compliance
Study Design: Randomised controlled trials (RCTs). Trials were accepted as RCTs if the allocation of subjects to treatment groups was described by the authors as either randomised or double-blind.
A discussion of outcome measures is presented in section 3.1.2.1. of the Assessment Report (see "Availability of Companion Documents" field.)
Exclusion Criteria
Studies were excluded if they included participants with secondary osteoporosis (e.g. related to therapy with corticosteroids) or drew their participants exclusively from patients with specific diseases known to affect fracture rates (e.g. Parkinson's disease).
Only published studies (including those only available in abstract form) were included. As unpublished studies are more likely than published studies to demonstrate small or absent treatment effects it is recognised that this approach is likely to overestimate the true effects of treatment. However it was not possible in the time available to seek out unpublished studies.
It had originally been intended to include all relevant studies whatever the language of publication. However for practical reasons it was in fact possible only to include those published in English French German Italian or Spanish. This led to the exclusion of one possibly relevant study published only in Japanese.
Sifting
In principle the references identified by the literature searches were sifted in two stages being screened for relevance first by title and then by abstract. However as it was not possible to identify all relevant studies with fracture outcomes from titles alone the title sifting stage was used essentially to reject studies which were clearly irrelevant. Following this the abstracts of all studies which used the relevant interventions in the relevant populations were screened (for studies which did not provide abstracts the full studies were screened). Twenty-eight studies which had been identified by the literature searches were not identified as relevant at the abstract sifting stage but were identified from other reviews as reporting fracture outcomes. The reason for this was that as fracture was only a secondary outcome measure in many studies it was therefore not reported in the abstract.
Economic Analysis
Identifying the Studies
The review has drawn on papers identified from a series of systematic searches undertaken for a Health Technology Assessment (HTA) review of treatment for osteoporosis. These include searches of papers reporting economic evaluation of the prevention and treatment of osteoporosis and those reporting on quality of life associated with the main fracture states breast cancer and coronary heart disease. Studies were identified through searches of electronic databases hand searching citation searching reference list checking and those known to researchers involved in the HTA review (Appendix 8 of the Assessment Report [see "Availability of Companion Documents" field]).
Number of Source Documents
Clinical Effectiveness
Ninety randomized controlled trials (RCTs) met the inclusion criteria relating to the five interventions (alendronate etidronate risedronate raloxifene and teriparatide) and to five comparators (calcium calcium plus vitamin D calcitriol HRT and exercise) as well as placebo or no treatment.
The Assessment Report reviewed data from 39 published RCTs in postmenopausal women where fracture or health related quality of life was a primary endpoint and where one of the five drugs of interest was compared with a relevant comparator.
Cost Effectiveness
The Assessment Group provided a cost-utility model.
Methods Used to Assess the Quality and Strength of the Evidence
Expert Consensus
Rating Scheme for the Strength of the Evidence
Not applicable
Methods Used to Analyze the Evidence
Meta-Analysis of Randomized Controlled Trials
Systematic Review with Evidence Tables
Description of the Methods Used to Analyze the Evidence
Note from the National Guideline Clearinghouse (NGC): The National Institute for Health and Clinical Excellence (NICE) commissioned an independent academic centre to perform a systematic literature review on the technology considered in this appraisal and prepare an assessment report. The assessment report for this technology appraisal was prepared by The University of Sheffield School of Health and Related Research [ScHARR]. (See the "Availability of Companion Documents" field.)
Clinical Effectiveness
Data Extraction Strategy
Data were extracted by one reviewer using customised data extraction forms. Where available the following data will be reviewed:
- Incident vertebral fractures
- Incident nonvertebral fractures
- Incident hip fractures
- Incident wrist fractures
- Quality of life
- Associated effects (both adverse and beneficial)
- Continuance and compliance
Quality Assessment Strategy
The methodological quality of all trials which met the inclusion criteria was assessed using the tool developed by Gillespie et al.* This tool was selected because it was intended specifically for the assessment of randomised or quasi-randomised trials of interventions designed to prevent fractures associated with osteoporosis.
The quality assessment tool included the following items:
- Adequacy of randomisation and masking of randomisation
- Blinded assessment of outcomes—whether outcome assessors were blind to subjects' treatment allocation
- Withdrawals—whether the outcomes of people who withdrew were described and included in the analysis
- Comparability of groups at baseline
- Confirmation of diagnosis of hip or other appendicular skeleton fracture
- Method of diagnosis of vertebral fracture
Definitions of the various levels of randomisation and concealment of randomization derived from Prendiville et al. 1988** were incorporated in the tool (see Appendix 6 of the Assessment Report [see "Availability of Companion Documents" field]).
It is recognised that the quality assessment tool assesses reporting quality and not necessarily the true methodological quality of each study. However where trials were reported in more than one publication the quality score was calculated on the basis of the combined data from all relevant publications.
Blinding of the quality assessors to author institution or journal was not considered necessary.
The quality assessment of studies included in the review of clinical effectiveness was carried out by one researcher.
*Gillespie W Avenell A Henry D O'Connell D Robertson J. Vitamin D and vitamin D analogues for preventing fractures associated with involutional and post-menopausal osteoporosis. The Cochrane Library (Oxford) **2001 Issue 4 (27p) (27 ref 21 bib) Update Software online of CD-ROM updated quarterly 2001; 2001-2ROM.
*Prendville W Elbourne D and Chalmers I. The effects of routine oxytocic administration in the management of the third stage of labour: an overview of the evidence from controlled trials. British Journal of Obstetrics & Gynaecology 1988; 95 3-16
Meta-Analysis Strategy
Studies which met the review's entry criteria were eligible for inclusion in the meta-analyses provided that they reported fracture incidence in terms of the number of subjects suffering fractures as this enabled calculation of the relative risk of subjects in the intervention group developing a new fracture or fractures compared with subjects in the control group. Studies which reported only numbers of fractures or fracture rates (i.e. numbers of fractures per hundred or thousand patient years) could not be included in the meta-analyses unless it was possible to obtain from the authors unpublished information on the number of subjects who suffered fractures. The meta-analysis of data relating to numbers of fractures or fracture rates would have violated the basic statistical assumption that the occurrence of one event does not increase the likelihood of a subsequent event since once a subject has suffered an osteoporotic fracture the risk of a subsequent fracture increases.
Ideally only those studies which had fracture as a primary endpoint would have been included in the meta-analyses. However pragmatically this was not possible as very few studies met this criterion (see Appendix 7 of the Assessment Report [see "Availability of Companion Documents" field]). Meta-analysis was carried out using Review Manager using the random-effects model as this both allows generalization beyond the sample of patients represented by the studies included in the meta-analysis and provides wider more conservative confidence intervals than the fixed-effects model.
Since the endpoint of interest was fracture it seemed appropriate (pace Meunier) to include open-label studies.
To ensure comparability the meta-analyses of vertebral fractures only pooled data from studies which used the same definition of vertebral fracture. Where possible data were pooled from studies using a definition which required a 20% or greater reduction in anterior middle or posterior vertebral height: as noted above this definition was felt to identify fractures more reliably than a definition which required a 15% or greater reduction.
Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations
Considerations
Technology appraisal recommendations are based on a review of clinical and economic evidence.
Technology Appraisal Process
The National Institute for Health and Clinical Excellence (NICE) invites 'consultee' and 'commentator' organisations to take part in the appraisal process. Consultee organisations include national groups representing patients and carers the bodies representing health professionals and the manufacturers of the technology under review. Consultees are invited to submit evidence during the appraisal and to comment on the appraisal documents.
Commentator organisations include manufacturers of the products with which the technology is being compared the National Health Service (NHS) Quality Improvement Scotland and research groups working in the area. They can comment on the evidence and other documents but are not asked to submit evidence themselves.
NICE then commissions an independent academic centre to review published evidence on the technology and prepare an 'assessment report'. Consultees and commentators are invited to comment on the report. The assessment report and the comments on it are then drawn together in a document called the evaluation report.
An independent Appraisal Committee then considers the evaluation report. It holds a meeting where it hears direct spoken evidence from nominated clinical experts patients and carers. The Committee uses all the evidence to make its first recommendations in a document called the 'appraisal consultation document' (ACD). NICE sends all the consultees and commentators a copy of this document and posts it on the NICE website. Further comments are invited from everyone taking part.
When the Committee meets again it considers any comments submitted on the ACD; then it prepares its final recommendations in a document called the 'final appraisal determination' (FAD). This is submitted to NICE for approval.
Consultees have a chance to appeal against the final recommendations in the FAD. If there are no appeals the final recommendations become the basis of the guidance that NICE issues.
Who is on the Appraisal Committee?
NICE technology appraisal recommendations are prepared by an independent committee. This includes health professionals working in the NHS and people who are familiar with the issues affecting patients and carers. Although the Appraisal Committee seeks the views of organisations representing health professionals patients carers manufacturers and government its advice is independent of any vested interests.
Rating Scheme for the Strength of the Recommendations
Not applicable
Cost Analysis
The Assessment Group provided a cost-utility model based on a modified individualised Markov approach. The cost effectiveness was estimated separately for women at different ages (50 60 70 and 80 years) who have a T-score of –2.5 standard deviations (SD) and who have had a fragility fracture; this was the baseline risk in the modelling. As fracture risk can be increased by a further decrease in bone mineral density (BMD) or by other clinical risk factors as described in section 2.6 of the original guideline document the Assessment Group also nominally increased the baseline risk by factors of 2 and 4 (respectively called 'doubled risk' and 'quadrupled risk' below).
The prevalence of fractures for women with a Z-difference of 0 was calculated and adjusted for different T-scores. For every age-cohort the Z-difference was calculated as the difference between the T-score of the hypothetical patient (T-score of –2.5 SD) and the average T-score of the age-cohort. The Assessment Group model was based on BMD data from the United Kingdom (UK) and calculated fracture risk based on femoral neck T-scores. The model simulated patients either until they died or for up to 10 years (5 years of treatment plus 5 years linear fall time [that is decline of effect to zero] except for teriparatide where the fall time was 1 year). Although the time horizon was 10 years the additional utility gained through mortality prevented was taken into consideration using a life-table approach. The comparator for the analyses was no treatment but an adequate intake of calcium and vitamin D was assumed for all patients.
The cost-utility model included three additional variables to determine an appropriate cost per quality adjusted life year (QALY) for all technologies under appraisal: an age dependent gradient of hip fracture risk by Z-difference the introduction of mortality related to vertebral and proximal humerus fractures and an increase in the disutility associated with proximal humerus fractures.
See section 4.2. of the original guideline document for a detailed discussion of the cost-effectiveness analysis.
Method of Guideline Validation
External Peer Review
Description of Method of Guideline Validation
Consultee organizations from the following groups were invited to comment on the draft scope Assessment Report and the Appraisal Consultation Document (ACD) and were provided with the opportunity to appeal against the Final Appraisal Determination.
- Manufacturer/sponsors
- Professional/specialist and patient/carer groups
- Commentator organisations (without the right of appeal)
In addition individuals selected from clinical expert and patient advocate nominations from the professional/specialist and patient/carer groups were also invited to comment on the ACD.
Major Recommendations
Note: This guideline has been updated. The National Guideline Clearinghouse (NGC) is working to update this summary. The recommendations that follow are based on the previous version of the guideline.
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.
- 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.
- 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.
- 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)
- 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
- 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.
- 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
Type of Evidence supporting the Recommendations
The type of evidence supporting the recommendations is not specifically stated.
Potential Benefits
- Appropriate use of alendronate etidronate risedronate raloxifene or teriparatide in postmenopausal women to reduce the risk of osteoporotic fracture
- All five interventions have been shown to reduce the risk of vertebral fracture in women with severe osteoporosis with adequate calcium intakes. Alendronate and raloxifene have also been demonstrated to reduce the risk of vertebral fracture in women with adequate calcium or vitamin D intakes who have osteoporosis without fracture. However only risedronate and teriparatide have also been demonstrated to reduce the risk of nonvertebral fracture in women with severe osteoporosis and adequate calcium intakes. Alendronate has been shown to do so in women with osteoporosis with or without fracture and with adequate calcium or vitamin D intakes. However none of these drugs have been demonstrated by direct comparison to be significantly more effective than either each other or the other active interventions reviewed in this report.
Potential Harms
Adverse Effects of Medication
- Alendronate: Adverse upper gastrointestinal (GI) events including nausea dyspepsia mild oesophagitis/gastritis and abdominal pain were reported in about one-third of the participants in studies of alendronate. However only one study found the increased frequency of these symptoms to be statistically significant relative to placebo. This is consistent with post-marketing studies indicating that around one-third of alendronate users experience upper-GI adverse events. In order to avoid oesophagitis the Summary of Product Characteristics now recommends that alendronate should be taken upon rising for the day with a full glass of water. It is possible that these instructions were not followed in all of the studies particularly the earlier ones.
- Etidronate: Higher rates of upper-GI adverse effects were found in the etidronate groups of four randomised controlled trials (RCTs) although the differences were not always statistically significant. However non-RCT evidence and testimonies from clinical experts and patient experts suggested that etidronate may be associated with fewer upper-GI adverse effects than are other bisphosphonates.
- Risedronate: Overall and upper-GI adverse events were similar in the risedronate and placebo groups in all of the studies.
- Raloxifene: The most serious adverse effect associated with raloxifene is the approximately three-fold increased risk of venous thromboembolism. Statistically significantly higher incidences of hot flushes arthralgia dizziness leg cramps influenza-like symptoms endometrial cavity fluid peripheral oedema and worsening diabetes have also been found with raloxifene compared with placebo.
- Teriparatide: Nausea and headaches occurred more frequently with 40 micrograms/day teriparatide in the main placebo-controlled trial. In the smaller placebo-controlled trial a proportion of women taking teriparatide were reported to suffer mild discomfort at the injection site. A systematic review of parathyroid hormone reported that treatment in a small proportion of women was associated with hypercalcaemia.
For full details of side effects and contraindications see the Summary of Product Characteristics available at http://emc.medicines.org.uk/.
Contraindications
Bisphosphonates (Alendronate Etidronate Risedronate)
- The use of bisphosphonates is contraindicated in people with hypocalcaemia. The use of risedronate and etidronate is contraindicated in people with severe renal impairment.
- Bisphosphonates should be used cautiously with women who have active upper gastrointestinal problems.
Raloxifene
Particular contraindications include a history of venous thromboembolism hepatic impairment cholestasis severe renal impairment undiagnosed uterine bleeding and endometrial cancer. Raloxifene should not be co-administered with systemic oestrogens and in patients with breast cancer it should not be used for osteoporosis treatment and prevention until treatment of the breast cancer including adjuvant therapy has been completed.
Parathyroid Hormone: Teriparatide
Particular contraindications include pre-existing hypercalcaemia severe renal impairment metabolic bone diseases other than primary osteoporosis (including hyperparathyroidism and Paget's disease of the bone) unexplained elevations of alkaline phosphatase and previous radiation therapy to the skeleton.
For full details of side effects and contraindications see the Summary of Product Characteristics available at http://emc.medicines.org.uk/.
Qualifying Statements
This guidance represents the view of the Institute which was arrived at after careful consideration of the available evidence. Health professionals are expected to take it fully 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.
Description of Implementation Strategy
Implementation and Audit
- All clinicians in National Health Service (NHS) Hospital and Primary Care Trusts who care for postmenopausal women who have had an osteoporotic fragility fracture should review their current practice and policies to take account of the guidance (see the "Major Recommendations" field).
- Local guidelines protocols or care pathways that refer to the care of postmenopausal women who have had an osteoporotic fragility fracture should incorporate the guidance.
- To measure compliance locally with the guidance the following criteria could be used. Further details on suggestions for audit are presented in Appendix C of the original guideline document.
- For a woman aged 75 years or older who has had an osteoporotic fragility fracture bisphosphonates are considered as treatment options for the secondary prevention of an osteoporotic fragility fracture without the need for dual energy X-ray absorptiometry (DEXA) scanning.
- For a woman aged between 65 and 74 years old who has had an osteoporotic fragility fracture bisphosphonates are considered as treatment options for the secondary prevention of an osteoporotic fragility fracture with DEXA-confirmed osteoporosis.
- For a postmenopausal woman younger than 65 years of age who has had an osteoporotic fragility fracture bisphosphonates are considered as treatment options if the woman has a very low bone mineral density or confirmed osteoporosis plus one or more additional age-independent risk factors.
- For a postmenopausal woman with osteoporosis who has had an osteoporotic fragility fracture raloxifene is considered as an alternative treatment option under the circumstances specified above if she meets any of the following.
- She has a contraindication to bisphosphonates.
- She is physically unable to comply with the special recommendations for use of bisphosphonates.
- She has had an unsatisfactory response to bisphosphonates.
- She is intolerant of bisphosphonates.
- For a woman aged 65 years or older who has had an unsatisfactory response to bisphosphonates or intolerance to bisphosphonates teriparatide is considered as a treatment option for the secondary prevention of an osteoporotic fragility fracture only if the woman either has an extremely low bone mineral density (BMD) or has a very low BMD plus multiple fragility fractures plus one or more age-independent risk factors.
- Local clinical audits on the care of women who have experienced an osteoporotic fragility fracture also could include criteria related to the prevention of falls based on the standards in the National Service Framework for Older People or criteria based on the clinical guidelines for prevention and treatment of osteoporosis published by the Royal College of Physicians. Issues that could be addressed in local clinical audits on osteoporosis include identifying high-risk patients maintaining patient adherence with bisphosphonate drug therapy educating patients about the condition and treatments appropriate investigation and the involvement of the multiprofessional team in managing patients with osteoporosis.
Implementation Tools
Audit Criteria/Indicators
Foreign Language Translations
Patient Resources
Quick Reference Guides/Physician Guides
For information about availability see the "Availability of Companion Documents" and "Patient Resources" fields below.
IOM Care Need
Living with Illness
Staying Healthy
IOM Domain
Effectiveness
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.
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
Note: This guideline has been updated. The National Guideline Clearinghouse (NGC) is working to update this summary.
Guideline Availability
Electronic copies of the updated guideline: Available in Portable Document Format (PDF) format from the National Institute for Health and Clinical Excellence (NICE) Web site.
Availability of Companion Documents
The following is available:
- Bisphosphonates (alendronate etidronate risedronate) selective oestrogen receptor modulators (raloxifene) and parathyroid hormone (teriparatide) for the secondary prevention of osteoporotic fragility fractures in postmenopausal women. Quick reference guide. London (UK): National Institute for Health and Clinical Excellence (NICE); 2005 Jan. 4 p. (Technology appraisal 87). Available in Portable Document Format (PDF) from the National Institute for Health and Clinical Excellence (NICE) Web site.
- The clinical effectiveness and cost effectiveness of prevention and treatment of osteoporosis. Assessment report. The School of Health and Related Research (ScHARR) University of Sheffield. 2003 Dec. Electronic copies: Available from the NICE Web site.
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.
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This NGC summary was completed by ECRI on April 4 2007.
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