- Absolute rather than relative risk should be used when assessing fracture risk
- A risk-assessment—FRAX or QFracture—tool should be used unless the person is aged <40 years
- Healthcare professionals should be aware that risk-assessment tools do not incorporate every factor that affects BMD (e.g. living in a care home, certain medications) and these should not be overlooked
- Measurement of BMD should not be routinely performed without prior assessment of fracture risk
- BMD measurement should be considered before starting treatments that have a rapid adverse effect on bone density
- NICE recommends using an age-related strategy, in conjunction with the presence of risk factors, in order to assess fragility fracture risk
- A recalculation of risk is not recommended unless there is a change to a person’s risk factors or their risk score was near the threshold for intervention.
|NICE Clinical Guideline 146 on Osteoporosis: assessing the risk of fragility fracture has been awarded the NHS Evidence Accreditation Mark.
This Mark identifies the most robustly produced guidance available. See evidence.nhs.uk/accreditation for further details.
Osteoporosis is a process in which bone density thins and bone architecture becomes fragile. It can lead to fragility fractures, which occur from events that normal healthy bone can withstand (e.g. falling on the wrists from a standing position). In the UK, osteoporosis leads to 300,000 fractures a year and it is estimated it will cost £2.2 billion per year by 2025.1,2 Hip fracture has a 20% mortality rate and vertebral fracture causes immense morbidity and pain.3
When I was first practising in 1983, it was obvious that a patient who was bent double and who demonstrated radiological thinning in spine X-rays, had osteoporosis. There were no treatment options at this time, apart from oily fish, which was recommended by the local geriatrician. Now, in addition to dual energy X-ray absorptiometry (DXA) scanning to quantify the density of a patient’s bones, there are medications such as bisphosphonates, which have been shown to increase bone density and decrease rates of fractures. The development of these drugs during my career as a GP was a revolution—a treatment that might prevent the devastation of hip and vertebral fracture. The majority of fragility fractures, however, do not occur in people who have low bone mineral density (BMD) and it is therefore important to perform an assessment of fracture risk that includes factors other than bone mineral density.
In August 2012, NICE published Clinical Guideline (CG) 146 on the assessment of people for risk of fragility fractures, which includes advice on when measurement of BMD is required.3,4 The recommendations were developed using the standard NICE guideline process of preparing a scope and recruiting a multidisciplinary team of independent experts to form the Guideline Development Group (GDG). NICE worked with the National Clinical Guideline Centre to develop review questions and assess current evidence; following a public consultation on draft recommendations, the GDG agreed the final guidance.3,4
Assessment of risk
The NICE guideline recommends the use of absolute risk rather than relative risk when assessing risk of fracture and that a risk calculator should be used for this purpose.3,4 There are two risk calculators that are validated in UK populations, FRAX® (www.shef.ac.uk/FRAX)5 and QFracture® (www.qfracture.org).6 These tools differ in their assessment of risk factors: FRAX can take into account BMD while QFracture covers a wider age range. The GDG agreed it was impossible to recommend one over the other as there was no evidence to show that either tool was superior. Obviously this is subject to change—Professor Hippesley-Cox from the University of Nottingham published a paper on an updated version of the QFracture tool in response to the draft version of the NICE guideline on fragility fracture risk, which included ethnicity as a risk factor and is capable of deriving 5-year risk in the very elderly; however, this model has yet to undergo external validation.7
Underestimation of risk
The evidence showed that the risk assessment tools may underestimate fracture risk under certain circumstances and healthcare professionals will need to take this into account if a person has:3,4
- multiple fractures
- had previous vertebral fractures
- a high alcohol intake
- taken more than 7.5 mg of prednisolone or equivalent per day for ?3 months
- secondary osteoporosis.
Calculation of fracture risk can also be affected by factors that may not be included in the risk-assessment tool, such as living in a care home, and taking medications that can affect bone metabolism, including anticonvulsants, retroviral drugs, proton pump inhibitors, selective serotonin reuptake inhibitors, and/or thiazolidinediones.3,4
|Box 1: Secondary causes of osteoporosis3,4|
Causes of secondary osteoporosis include:
Who should have a measurement of BMD?
The evidence reviewed during the development of the NICE guideline indicated that measurement of BMD did not necessarily improve the accuracy of risk assessment. It is therefore recommended that a risk-assessment tool is used before considering a measurement of BMD.3,4 A measurement of BMD is not needed in people at low risk but it may be helpful for people at a treatment threshold as the inclusion of BMD may alter the risk score in this situation. Measurement of BMD is the only way of assessing risk in people below the age range of the risk calculators (<40 years).3,4
It is worth considering the measurement of BMD before initiating treatments that can have a rapid adverse effect on bone density, for example, sex hormone deprivation for treatment of breast or prostate cancer.3,4
Who should have a risk assessment?
As age is one of the most important predictors of fragility fracture risk, NICE has recommended an age-related strategy in risk assessment (see Figure 2):3,4
- all women aged ?65 years and all men aged ?75 years should have a fragility fracture assessment
- women aged <65 years and men <75 years who have risk factors present, should have a fragility fracture assessment. Risk factors include:
- previous fragility fracture
- current or frequent recent use of oral or systemic glucocorticoids
- history of falls
- family history of hip fracture
- other causes of secondary osteoporosis (see Box 1)
- low body mass index (BMI) (<18.5 kg/m2)
- alcohol intake of >14 units per week for women and >21 units per week for men.
- people aged <50 years should not have a routine risk assessment unless they have major risk factors (e.g. current or frequent recent use of oral or systemic glucocorticoids, untreated premature menopause, or previous fragility fracture).
The assessment of risk in people aged <40 years will require measurement of BMD and this should be considered only in people with major risk factors such as a history of multiple fragility fracture, major osteoporotic fracture, or current or recent use of high-dose oral or high-dose systemic glucocorticoids (>7.5 mg prednisolone or equivalent per day for ?3 months or longer).3,4
Recalculation of risk is not recommended unless there is a change in a person’s risk factors or the risk score was near the threshold for intervention—in the latter case, this should not occur for a minimum of 2 years as BMD changes slowly.3,4
Figure 2: Risk assessment of fragility fracture4
BMD=bone mineral density; DXA=dual-energy X-ray absorptiometry; BMI=body mass index
Secondary osteoporosis can be caused by a number of conditions (see Box 1). Some of these are obvious, such as rheumatoid arthritis, while others are subtle and although they may not significantly increase individual fragility risk, the overall effects can be substantial if the condition is common (e.g. diabetes).
A menopausal woman who is concerned that she may have osteoporosis should have a risk assessment before measurement of BMD is considered. If no other risk factors are present, she will have a low fracture risk and will therefore not require a scan; a further risk assessment will not need to be performed for at least 2 years unless her risk factors change.
The NICE guideline does not cover the preventive treatment of fragility fractures and/or the thresholds for intervention. NICE has previously issued guidance on the use of bisphosphonates and other drugs aimed at reducing fracture rates.8—10 An update of these technology appraisals is planned in light of publication of CG146.11
|NICE implementation tools|
NICE has developed the following tools to support implementation of Clinical Guideline 146 (CG146) on Osteoporosis: assessing the risk of fragility fracture. The tools are now available to download from the NICE website: www.nice.org.uk/CG146
NICE support for commissioners
Costing reports are estimates of the national cost impact arising from implementation based on assumptions about current practice, and predictions of how it might change following implementation of the guideline.
Costing templates are spreadsheets that allow individual NHS organisations and local health economies to estimate the costs of implementation taking into account local variation from the national estimates, and they quickly assess the impact the guideline may have on local budgets.
NICE support for service improvement systems and audit
Baseline assessment tool
The baseline assessment is an Excel spreadsheet that can be used by organisations to identify if they are in line with practice recommended in NICE guidance and to help them plan activity that will help them meet the recommendations.
Clinical audit tools
Clinical audit tools are developed to help with clinical audit. They contain clinical audit standards, a data collection form, and an action plan template.
Electronic audit tools
Electronic audit tools are Excel spreadsheets developed to help with clinical audit. They contain audit standards, data collection sheets, a clinical audit report, and an action plan template.
The NICE guideline gives me, as a busy locum GP, a clear handle on when to consider referral for a DXA scan. The risk assessment tools, FRAX and QFracture, are easy to access and use on the internet and are embedded in some GP software; however, I find that on many occasions, consideration of fragility fracture risk is not the main reason why a patient consults general practice. I recently saw an elderly lady with severe headaches and temporal tenderness. Her temporal arteritis responded dramatically to high-dose steroids. Although assessment of her fracture risk was on my agenda, it was not a priority of hers, and required a further consultation. General practice is masterful at adapting to changing healthcare needs and I am sure that we can manage assessment of fragility fracture with the help of the practice team, however, we need to use DXA scanning resources judiciously, providing care to people who require it rather than people who are in good health but are worried.
The quality and outcomes framework as well as enhanced service contracts have made a start in developing databases for patients with possible fragility fractures and prompting subsequent assessment. This needs to be carried forward within a structured primary care service to provide comprehensive coverage of all patients at risk. The use of GP databases to identify people at risk of fragility fracture may be a way forward in the future.
Ensuring comprehensive fragility fracture assessment for all people at risk will require substantial organisational arrangements within primary care. It may be time for the new commissioning bodies to be bold and use the evidence from NICE to provide a utilitarian approach to NHS care, ensuring that the determination of fragility fracture risk results in DXA scans only for those who are at higher risk.
There is enormous potential within the field of fragility fracture for the prevention of serious illness and premature death by identifying and providing treatment for individuals at risk—primarily the elderly. We have the tools, and NICE has defined who should be assessed: can we as doctors, nurses and other healthcare professionals, in partnership with patients and NHS management, rise to the challenge of eliminating fragility fractures?
- If implemented literally, the NICE guideline would place a significant extra burden on primary care
- Assessment is more likely to be undertaken if the risk assessment tools are embedded in practice software systems with prompts suggesting when to consider fracture assessment (e.g. over 65 years of age and excess alcohol consumption)
- Such assessments will drive demand for DXA scans and commissioners will need to be prepared for the extra supply and cost of such scans
- Commissioners might want to agree a priority for DXA scans in secondary prevention over primary prevention if supply is limited, as the absolute risk is higher in this group and demand is driven by QOF requirements
- Commissioners should consider local care pathways or guidelines for patients with special needs (e.g. in residential care homes)
- There is still uncertainty over primary prevention of osteoporosis and definitive guidance from NICE is still awaited
- Tariff prices for DXA scan (including report) = Â£80 (RA15Z).a
- The British Orthopaedic Association. The care of patients with fragility fracture. London: British Orthopaedic Association, 2007. Available at: www.fractures.com/pdf/BOA-BGS-Blue-Book.pdf
- Burge R, Worley D, Johansen A et al. The cost of osteoporotic fractures in the UK: projections for 2000–2020. J Med Econ 2001; 4: 51–52.
- National Institute for Health and Care Excellence. Osteoporosis: assessing the risk of fragility fracture. Clinical Guideline 146. London: NICE, 2012. Available at: www.nice.org.uk/guidance/CG146
- National Clinical Guideline Centre. Osteoporosis: fragility fracture risk. Short Clinical Guideline 146. London: National Clinical Guideline Centre, 2012. Available at: www.nice.org.uk/nicemedia/live/13857/60400/60400.pdf
- FRAX® WHO Fracture risk assessment tool website. www.shef.ac.uk/FRAX/ (accessed 18 October 2012).
- QFracture® 2012 risk calculator website. www.qfracture.org (accessed 18 October 2012).
- Hippisley-Cox J, Coupland C. Derivation and validation of updated QFracture algorithm to predict risk of osteoporotic fracture in primary care in the United Kingdom: prospective open cohort study. BMJ 2012; 344: e3427.
- National Institute for Health and Care Excellence. Alendronate, etidronate, risedronate, raloxifene and strontium ranelate for the primary prevention of osteoporotic fragility fractures in postmenopausal women (amended). Technology Appraisal 160. London: NICE, 2008. Available at: www.nice.org.uk/TA160
- National Institute for Health and Care Excellence. Alendronate, etidronate, risedronate, raloxifene, strontium ranelate and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women (amended). Technology Appraisal 161. London: NICE, 2008. Available at: www.nice.org.uk/TA161
- National Institute for Health and Care Excellence. Denosumab for the prevention of osteoporotic fractures in postmenopausal women. Technology Appraisal 204. London: NICE, 2010. Available at: www.nice.org.uk/TA204
- National Institute for Health and Care Excellence website. TA160 Osteoporosis—primary prevention: review update—August 2012www.www.nice.org.uk/guidance/TA160/ReviewUpdateAugust2012 (accessed 18 October 2012).G