Fractures as a result of osteoporosis are a major cause of morbidity and mortality in the elderly population. One woman in two and one man in five aged 50 years or older will sustain an osteoporotic fracture during their lifetime1 and the cost of these fractures to the health services is approximately £2 billion per year.2 Demographic population changes expected by 2050 will result in a doubling of the number of patients with osteoporotic hip fractures.2 Fractures occurring in people over the age of 60 years account for more than 2 million hospital bed days in the UK, exceeding the bed occupancy attributable to diabetes, ischaemic heart disease, heart failure, or chronic obstructive pulmonary disease.1
Need for a new guideline
Current guidelines for the management of osteoporosis include those produced by the Royal College of Physicians (RCP) in 2000 for prevention and treatment of post-menopausal osteoporosis and in 2002 for men and women taking oral glucocorticoids.3,4 In addition, in 2005, NICE produced guidance on the secondary prevention of osteoporotic fractures in post-menopausal women with osteoporosis.5 All of these guidelines exclude newer treatments that have been licensed in the past three years.
Further final appraisal determinations from NICE for the primary and secondary prevention of osteoporotic fracture are soon to be published, but will not include guidance on: patients receiving glucocorticoid therapy; men with osteoporosis; or post-menopausal women at high risk of fracture but with a bone mineral density (BMD) T-score higher than ?–2.5 SD. Furthermore, newer treatments such as ibandronate and zoledronate will not be included in the appraisals. However, these areas will be covered by the future NICE clinical guideline, the timing of which is uncertain but is unlikely to be within the next 12 months.
Finally, the World Health Organization (WHO)-supported approach to the assessment of fracture probability (FRAX®: www.shef.ac.uk/FRAX), which generates 10-year fracture probabilities and is now widely used in clinical practice, is not incorporated in current guidelines.6
Against this background, the National Osteoporosis Guideline Group (NOGG), in collaboration with others, has updated the original Royal College of Physicians 2000 and 2002 guidelines to cover glucocorticoid therapy, the assessment of men as well as women with osteoporosis, and all interventions currently in use. Furthermore it incorporates the WHO-supported fracture risk algorithm.1
How the NOGG guideline will improve osteoporosis management
In previous guidelines, intervention thresholds have been based mainly on a history of fracture and/or BMD T-scores, assessed by dual energy X-ray absorptiometry (DXA). However, other factors also increase fracture risk and are partially independent of bone mineral density (see Table 1). In FRAX®, consideration of these factors is used to improve fracture risk prediction and the targeting of high-risk individuals who will benefit from treatment. The output of FRAX® is a 10-year probability of major osteoporotic fracture (hip, spine, forearm, or humerus) and 10-year probability of hip fracture: in most cases the former is used to determine the need for intervention.
In the NOGG guideline, intervention thresholds are set at a fracture probability equivalent to that of a post-menopausal woman with a history of fracture.3,7 Thus intervention is determined solely by age-specific absolute risk, and the proportion of individuals eligible for treatment increases with age. All the NOGG recommendations for treatment are cost effective, based on use of alendronate for the majority of patients (approximately 80%),8 with alternative options (other bisphosphonates, raloxifene, or strontium ranelate) for the remaining 20%.
The NOGG guideline is web-based (www.shef.ac.uk/NOGG) and provides a rapid, simple, and stepwise approach to the management of osteoporosis in clinical practice. The first step is estimation of fracture probability using the FRAX® tool (see Figure 1). The value obtained is then automatically superimposed on a graphical representation of the intervention thresholds. These graphs can be found on the NOGG website. Men and women with probabilities below the lower assessment threshold can be reassured. If the initial FRAX® estimation is made without a measurement of BMD and the value lies in the intermediate zone, BMD measurement should be considered and fracture probability recomputed using FRAX®. Men and women with probabilities above the intervention threshold should be considered for treatment.
In post-menopausal women who have sustained an osteoporotic fracture, it is often appropriate to commence treatment without measurement of BMD. However, in younger post-menopausal women, BMD measurement should be considered, particularly in cases where the degree of trauma associated with the fracture is unclear.
The Executive Summary and Pocket Summary Guide of the NOGG guideline, a Patient Information Leaflet, and some Frequently Asked Questions (FAQs) can also be accessed via the website.
Table 1: Clinical risk factors known to increase the risk of fracture
|BMI=body mass index|
Figure 1: The WHO fracture risk assessment tool (FRAX®). Data have been entered for a 60-year-old woman who is a current smoker with a previous fracture. The 10-year probability of sustaining a major osteoporotic fracture is 14% and of a hip fracture, 4.4%
|Reproduced with kind permission from the WHO Collaboration Centre for the Metabolic Bone Diseases www.shef.ac.uk/FRAX|
Improvements to current recommendations
The approach outlined in the NOGG guideline offers several advantages over current strategies, and has the potential to improve significantly the management of osteoporosis. Advantages are:
- treatment decisions are based on 10-year fracture probability, rather than on T-scores±fracture, thus providing more accurate and cost-effective targeting of therapy
- men over 50 years are included
- assessment of fracture risk and treatment decisions in clinical practice can be made rapidly using a single website (www.shef.ac.uk/NOGG)
- the fracture risk assessment includes glucocorticoid therapy, so separate guidelines are not required for patients with glucocorticoid-induced osteoporosis
- all currently approved treatments are included in the guideline
- the recommended treatment scenarios are cost effective.
Promoting best practice in primary care
Results from two recent studies in the UK have demonstrated a significant care gap in treating elderly patients with fractures, with only 25% or fewer receiving bone-protective therapy.9 Initiatives such as fracture liaison services, osteoporosis champions in primary care, greater patient empowerment, and better recording and coding of indicators related to osteoporosis provide approaches that should help to address current deficits in care. These are detailed in the Blue Book recently produced by the British Orthopaedic Association and British Geriatrics Society, which also stresses the importance of addressing falls-related risk factors in patients at high risk of fracture.2
Primary care organisations are ideally placed to manage osteoporosis, a chronic disease in which fracture is the clinical outcome. The use of Read codes for osteoporosis, falls, and fractures enables the identification of high-risk individuals and facilitates audit. In addition, follow-up of patients on bone-protective therapy is important, because poor adherence to osteoporosis medications is associated with increased fracture rates.10
Osteoporosis is included in the new clinical direct enhanced services as part of the 2008/2009 contract negotiations. It recommends that practices should hold and maintain a register of women aged over 65 years with osteoporotic fractures and should audit the use of DXA and bone-sparing therapy in such women.
Key priorities for implementation
The recent advances in fracture risk prediction and in cost-effective treatments to lessen fracture risk can be used to make significant reductions in the burden of osteoporotic fractures in the elderly. Key priorities for implementation within primary care are appropriate assessment and treatment of:
- men and women who present with osteoporotic fracture
- post-menopausal women, and of men over the age of 50 years, with a previous history of osteoporotic fracture
- post-menopausal women and men over the age of 50 years who have been receiving continuous oral glucocorticoid therapy for ?3 months.
In these high-risk groups, assessment of fracture risk using the FRAX® tool is indicated and bone-protective intervention should be considered in individuals with a 10-year fracture probability that exceeds the intervention threshold.
Members of the NOGG guideline development group:
- Professor J Compston (Chair) Department of Medicine, University of Cambridge School of Clinical Medicine, Cambridge
- Dr A Cooper, Bridge Medical Centre, Crawley, West Sussex
- Professor C Cooper, MRC Epidemiology Resource Centre, University of Southampton, Southampton General Hospital, Southampton; Department of Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford
- Professor R Francis, School of Clinical Medical Sciences, University of Newcastle, Newcastle upon Tyne
- Professor J Kanis, WHO Collaborating Centre for Metabolic Bone Diseases, University of Sheffield
- Professor D Marsh, Dept of Clinical Orthopaedics, University College London; Royal National Orthopaedic Hospital, Stanmore
- Dr E McCloskey, Northern General Hospital, Sheffield
- Professor D Reid, Division of Applied Medicine, University of Aberdeen
- Dr P Selby, Department of Medicine, Manchester Royal Infirmary
- Ms M Wilkins, Patient Representative.
The National Osteoporosis Guideline Group gratefully acknowledges the collaboration of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis and the support of the Bone Research Society, British Geriatrics Society, British Orthopaedic Association, Bone Research Society, British Society of Rheumatology, International Osteoporosis Foundation, National Osteoporosis Society, Osteoporosis 2000, Osteoporosis Dorset, Primary Care Rheumatology Society, Royal College of Physicians, and Society for Endocrinology.
- National Osteoporosis Guideline Group on behalf of the Bone Research Society, British Geriatrics Society, British Orthopaedic Association, British Society of Rheumatology, National Osteoporosis Society, Osteoporosis 2000, Osteoporosis Dorset, Primary Care Rheumatology Society, and Society for Endocrinology. Osteoporosis—clinical guideline for prevention and treatment. London: NOGG, 2008.
- British Orthopaedic Association, British Geriatrics Society. The care of patients with fragility fracture. London: BOA, BGS, 2007.
- Royal College of Physicians & Bone and Tooth Society of Great Britain. Osteoporosis—clinical guidelines for prevention and treatment; update on pharmacological interventions and an algorithm for management. London: RCP, 2000.
- Bone and Tooth Society, National Osteoporosis Society, Royal College of Physicians. Glucocorticoid-induced osteoporosis: guidelines for prevention and treatment. London: RCP, 2002.
- National Institute for Health and Care Excellence. Bisphosphonates (alendronate, etidronate, risedronate), selective oestrogen receptor modulators (raloxifene) and parathyroid hormone (teriparatide) for the secondary prevention of osteoporotic fragility fractures in postmenopausal women. Technology Appraisal 87. London: NICE, 2005.
- World Health Organization Scientific Group. The assessment of osteoporosis at the primary health care level. Summary Meeting Report. Geneva: WHO, 2007.
- Kanis J, McCloskey E, Johansson H et al; National Osteoporosis Guideline Group. Case finding for the management of osteoporosis with FRAX®—assessment and intervention thresholds for the UK. Osteoporos Int 2008; 19 (10): 1395–1408.
- Kanis J, Adams J, Borgstrom F. The cost-effectiveness of alendronate in the management of osteoporosis. Bone 2008; 42 (1): 4–15.
- Hippisley-Cox J, Bayly J, Potter J et al. Evaluation of standards of care for osteoporosis and falls in primary care. London: QRESEARCH, The Information Centre for Health and Social Care, 2007.
- Compston J, Seeman E. Compliance with osteoporosis therapy is the weakest link. Lancet 2006; 368 (9540): 973–974. G
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