Dr David Stephens offers an overview of the NICE quality standard on osteoporosis and discusses how to identify, assess, and manage people who may be at risk from fragility fracture

Dr David Stephens

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Read this article to learn more about:

  • recent national guidance on osteoporosis
  • major risk factors for fragility fracture
  • how to assess, who to treat, and when to review.

Key points

Commissioning messages

Osteoporosis is a thinning of the bone almost universally present in old age, especially in women. It presents with fractures usually of the hip, spine, and wrist and costs the NHS an estimated £4.4 billion a year.1 Osteoporosis results in 79,000 hip fractures annually.2 GPs need to know what to do for their patients with osteoporosis, and although it seems to be a straightforward clinical subject, there are some fundamentally challenging aspects, for example:

  • the name: ‘osteoporosis’ is the name we all know but experts prefer ‘fragility fracture risk’ as this defines the spectrum of a condition that may or may not need treatment
  • when to treat: practitioners are exhorted to treat on the basis of evidence, but with osteoporosis evidence seems to be lacking and conflicting as to who should be offered treatment for fracture prevention and how best to assess risk.3

Recent guidance on osteoporosis

To address the issues of assessment and treatment, three national guidelines and a technology appraisal have been published in the UK in recent years:

  • NICE Clinical Guideline (CG) 146 on Osteoporosis: assessing the risk of fragility fracture (2012, updated February 2017), provides guidance on fragility fracture risk assessment in people aged 18 years and over with osteoporosis and on the selection and use of risk assessment tools in adults at risk of fragility fractures. It agrees that two tools, FRAX® and QFracture®, are equally good for estimating 10-year predicted absolute fragility fracture risk and that either could be used to decide whether a person needs a dual-energy X-ray absorptiometry (DXA) scan, which is the gold standard for diagnosis3
  • National Osteoporosis Guideline Group (NOGG) Clinical guideline for the prevention and treatment of osteoporosis (2008, updated March 2017) covers assessment, diagnosis, therapeutic interventions, and management strategies for the prevention of osteoporotic fracture in postmenopausal women and in men age 50 years or over. This guideline is accredited by NICE; it references FRAX© as the assessment tool2
  • In 2015, the Scottish Intercollegiate Guidelines Network (SIGN) published its comprehensive guideline SIGN 142, Management of osteoporosis and the prevention of fragility fractures. This guideline has been accredited by NICE. Here, QFracture® is favoured as the assessment tool for deciding who should be assessed with a DXA scan, because the guideline states that it has been extensively validated in the UK, includes more variables, and can be used for a broader age range4
  • NICE Technology Appraisal (TA) 161 Alendronate, etidronate, risedronate, raloxifene, strontium ranelate and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women (2008, updated 2011) contains recommendations about these medications for the secondary prevention of fragility fractures in postmenopausal women with osteoporosis who have had a clinically apparent osteoporotic fragility fracture.5

There remains perhaps insufficient evidence on people at medium risk for healthcare professionals to be categorical about who should and who should not be treated in this group. It is agreed that high-risk patients should be treated and low-risk patients should not have a DXA scan,3,4 but while further trial evidence is awaited, NOGG guidance is available, which includes a range of intervention thresholds.2

NICE Quality Standard 149 on osteoporosis

NICE published four quality statements6 in April 2017 for high‑quality care in priority areas for improvement for osteoporosis, including assessing risk and preventing fragility fractures (see Table 1; see also Box 1 for a list of definitions included in NICE QS149 and discussed in this article).

Table 1: NICE quality standard for Osteoporosis—list of quality statements6
No. Quality statement
1 Adults who have had a fragility fracture or use systemic glucocorticoids or have a history of falls have an assessment of their fracture risk.
2 Adults at high risk of fragility fracture are offered drug treatment to reduce fracture risk
3 Adults prescribed drug treatment to reduce fracture risk are asked about adverse effects and adherence to treatment at each medication review.
4 Adults having long-term bisphosphonate therapy have a review of the need for continuing treatment.
National Institute for Health and Care Excellence (2017). Osteoporosis. NICE Quality Standard 149. Available from: www.nice.org.uk/qs149
NICE has not checked the use of its content in this article to confirm that it accurately reflects the NICE publication from which it is taken.

Box 1: NICE quality standard on osteoporosis—some definitions6

At high risk of fragility fracture

Women with a prior fragility fracture (particularly hip or vertebral fracture) and men and women with a 10‑year probability of a major osteoporotic fracture derived from FRAX®, above the upper assessment threshold, should be considered for treatment (see Table 2). Men and women with a 10-year probability between the upper and lower assessment threshold should be referred for bone mineral density measurement and their fracture probability reassessed. If their 10-year fracture probability is above the intervention threshold after reassessment (see Table 2), treatment should be offered.

Medication review

The review should include:

  • asking about adverse effects, including upper gastrointestinal adverse effects (such as dyspepsia or reflux), symptoms of atypical fracture (including new onset hip, groin, or thigh pain), and dental problems
  • asking about adherence to treatment, including following the recommended method of taking the treatment
  • discussing alternative treatment options if adverse effects are unacceptable or the person has difficulty adhering to treatment.

Long-term bisphosphonate therapy

Adults who have been taking zoledronic acid for 3 years or alendronate, ibandronate, or risedronate for 5 years should have a review of the need for continuing treatment.

Review of the need for continuing treatment

Continuation of treatment is recommended for people with any of the following risk factors:

  • age over 75 years
  • previous hip or vertebral fracture
  • one or more low trauma fractures during treatment (after poor adherence to treatment, for example less than 80% of treatment has been taken, and causes of secondary osteoporosis have been excluded)
  • current treatment with oral glucocorticoids of 7.5 mg or more prednisolone/day or equivalent.

For people without risk factors, arrange a dual-energy X-ray absorptiometry (DXA) scan and consider:

  • continuing treatment if the T-score is less than –2.5, and reassessing fracture risk and bone mineral density (BMD) every 3 to 5 years
  • stopping treatment if the T-score is greater than –2.5, and reassessing their fracture risk and BMD after 2 years.
National Institute for Health and Care Excellence (2017). Osteoporosis. NICE Quality Standard 149. Available at: www.nice.org.uk/qs149
NICE has not checked the use of its content in this article to confirm that it accurately reflects the NICE publication from which it is taken.
Table 2: Lower and upper assessment thresholds and intervention thresholds for major osteoporotic fracture probability based on fracture probabilities derived from FRAX (BMI set to 25 kg/m2)6
  10-year probability of a major osteoporotic fracture (%)
Age (years) Lower assessment threshold Upper assessment threshold Intervention threshold
40 2.6 7.1 5.9
45 2.7 7.2 6.0
50 3.4 8.6 7.2
55 4.5 11 9.4
60 5.9 14 12
65 8.4 19 16
≥70 11 24 20
Reproduced with permission from McCloskey et al. (2015) FRAX-based assessment and intervention thresholds—an exploration of thresholds in women aged 50 years and older in the UK. Osteoporosis Int (2015); 26 (8): 2091–2099.
National Institute for Health and Care Excellence (2017). Osteoporosis. Quality Standard 149. Available from: www.nice.org.uk/qs149
NICE has not checked the use of its content in this article to confirm that it accurately reflects the NICE publication from which it is taken.

Assessment of fragility fracture risk—statement 1

Fragility fractures arise from mechanical forces that would not ordinarily result in fracture (low‑level or ‘low energy’ trauma);7 these are quantified by The World Health Organization as forces equivalent to a fall from a standing height or less. Fragility fractures occur most commonly in the bones of the spine (vertebrae), hip (proximal femur), and wrist (distal radius) but may also occur in the arm (humerus), pelvis, ribs, and other bones.6

Fracture risk assessment involves using either FRAX® or QFracture® within their allowed age ranges to calculate the risk of fragility fracture occurring over the next 10 years.3 QFracture® is the tool of choice in Scotland.4

Patients who use systemic glucocorticoids. NICE QS149 and FRAX® define these as people who are currently taking systemic glucocorticoids, or who have been using systemic glucocorticoids for more than 3 months, at a dose of prednisolone of 5 mg daily or more (or equivalent doses of other glucocorticoids).6,8

A fall is defined as an unintentional or unexpected loss of balance resulting in coming to rest on the floor, the ground, or an object below knee level. Adults aged 50 years and over should have a fracture risk assessment if they have a history of falls (i.e. if they have had one or more falls in the past 12 months).6

The advisory committee for NICE QS149 considered recommending an assessment for fragility fracture for all people with risk factors but it was felt that this would create too much of a burden on primary care.9 In the author’s opinion, if such an assessment was automatic for all people, like the cardiovascular risk assessments provided by some GP systems, and could be self‑populated from the GP database, it would be less burdensome to undertake.

Who should be treated? 

In the absence of good randomised control trial evidence, NICE has used the NOGG guideline, which gives advice on when to arrange a DXA scan.2 For example, if a man aged 65 years has a risk of less than 6% of fracture in 10 years, then he is at low risk; if his risk is above 15%, he is at high risk. In high‑risk patients, treatment without a DXA scan could be considered; for medium-risk patients, a DXA could be considered; and for low-risk patients, a DXA is not needed.

NOGG has developed intervention thresholds that indicate to clinicians those patients who would probably benefit from treatment. These thresholds are available on the NOGG website and are adjusted so that the risks and age of the patient lie below the high risk levels.10 See also Table 2.

Case finding and individualised care 

Fracture liaison services working between primary and secondary care have a major role to play in identifying and initiating treatment of patients with osteoporosis. The Royal College of Physicians has recently completed an audit of fracture liaison services in England identifying where improvements are needed in the assessment and treatment of osteoporosis.11

On the other hand, over-diagnosis is now an emerging theme for many conditions that GPs can predict with risk scores and a blood test. So, as with cardiovascular risk and chronic kidney disease, GPs should be careful to judge the necessity for treatment where a condition is asymptomatic and may never cause illness in the patient’s lifetime. It is important with all patients to treat the patient as an individual and to apply the recommendations in the context of their whole situation. While treatment may be recommended in a very elderly patient with dementia or a young patient with advanced cancer, it is the GP’s responsibility to make a considered judgment as to whether this is appropriate for each individual patient. 

Starting drug treatment—statement 2

General practitioners, specialists, and specialist nurses need to know when to prescribe drug treatments to strengthen patients’ bones and reduce their fracture risk, and offer these to adults at high risk of fragility fracture (see Box 1 for NICE’s definition of ‘high risk’ in the context of this quality statement).6 The bisphosphonates alendronate and risedronate are the treatments of choice.2 Other bisphosphonates include ibandronate, and zoledronic acid. Non‑bisphosphonates include raloxifene, strontium ranelate, denosumab, teriparatide, calcitriol, and hormone replacement therapy. Consult the summary of product characteristics for full information about licensing indications and contraindications for all therapies.12

Currently, at best only 51% of patients who have a fragility fracture receive treatment via fracture liaison services. It is estimated that if all fracture patients in England received even this level of service, 21,848 fragility fractures would be prevented (including 9157 hip fractures) and the NHS would save over £151 million over a 5‑year period.11

Adverse effects and adherence to treatment—statement 3

Reviewing medication is important and also evidence-based, as 50% of postmenopausal women in the UK prescribed with an osteoporosis therapy in primary care stop taking their medication within a year.11,13 See Box 1 for NICE’s definition of a medication review in the context of this quality statement.6

Bone‑strengthening drugs cause side-effects and a review of the patient’s concordance is good practice. It is important to ensure that the patient attends for dental care to detect osteonecrosis of the jaw, which is a rare but serious side-effect of treatment. Oesophageal irritation is another less serious but important side-effect. 

Polypharmacy also needs to be reviewed. The 2017 NOGG guideline states that primary care physicians should follow up patients at 4 and 12 months to review use of medications that increase the risk of falls and/‌or fracture, ensure co‑prescription of calcium and vitamin D, and monitor adherence to therapy.2 In addition, people taking treatment for osteoporosis need a longer-term review of their medication and consideration as to whether a further DXA scan is indicated, based on NICE recommendation (see below).2

Long-term follow up—statement 4

See Box 1 for NICE’s definition of long-term bisphosphonate therapy and of review of the continuing need for treatment.6

The recent NICE Guideline 56 on Multimorbidity should be considered when reviewing patients who have long-term conditions.14 This states:

  • Tell a person who has been taking bisphosphonate for osteoporosis for at least 3 years that there is no consistent evidence of:
    • further benefit from continuing bisphosphonate for another 3 years
    • harms from stopping bisphosphonate after 3 years of treatment.
  • ‘Discuss stopping bisphosphonate after 3 years and include patient choice, fracture risk, and life expectancy in the discussion.’ 

However SIGN 142 guidance says:‘Alendronic acid may be continued for up to 10 years in postmenopausal women with osteoporosis, especially those that are at high risk of vertebral fracture.’

SIGN recommends using other medications for between 3 and 10 years.4

Implementation

In general practice, assessment and treatment of osteoporosis takes time and is often tagged on to a 10‑minute consultation, making it challenging to achieve national standards.9 Initiatives that might help to overcome this could, in the author’s opinion, include:

  • having a dedicated fragility fracture clinic for assessment and review of all patients with risk fractures, possibly via an enhanced service payment
  • automatic self-populating computerised calculation of FRAX® or QFracture®
  • IT systems that pick out those patients with the main risk factors.

Conclusion

The provision of services for osteoporosis in primary care has a long way to go to ensure all patients at risk of a fragility fracture benefit from bone-strengthening medication. If all patients at high risk were treated with bone-strengthening treatments, the number of hip fractures, vertebral fractures, and radial fractures treated by the NHS could be dramatically reduced. Saving money for the NHS is important but saving lives and preventing disability is paramount. Hip fracture has a 21% mortality.15 The setting of these quality standards is a good start on this journey.

Key points

  • Know the main risk factors:
    • fragility fracture
    • systemic steroids 
    • falls
  • Use FRAX® or QFracture® to assess fracture risk
  • Decide whether to treat, arrange a DXA scan, or just advise on lifestyle
  • Use the DXA scan result or NICE/NOGG guidance to guide treatment
  • Choose the most cost-effective treatment
  • Review patients at 4 and 12 months after starting treatment, and then annually thereafter
  • Be aware of the side-effects of treatment and when to reassess or stop treatment
  • Consider over-diagnosis and polypharmacy in the treatment of osteoporosis.

DXA=dual-energy X-ray absorptiometry; NOGG=National Osteoporosis Guideline Group

GP commissioning take home messages for England

written by Dr David Jenner, GP, Cullompton, Devon

  • The detection and treatment of osteoporosis or fragility fracture risk is complicated and covered by several different guidelines with slightly different recommendations
  • The evidence, though, for secondary prevention of further fragility fracture following a first fracture is clearer and this group is readily identified, making it a clear priority for commissioners to address
  • Effective fracture liaison services to which patients are referred following an initial fragility fracture are recommended by NICE and can be very cost effective:
    • commissioners should therefore ensure that a fracture liaison service is commissioned, whether from secondary care or via primary care
  • The QOF still rewards practices for the identification of fragility fractures and then referral for DXA and treatment of diagnosed osteoporosis, so primary care should have direct access to DXA and specialist advice where needed
  • Local formularies should identify the risks and benefits of agents used to treat osteoporosis and what precautions are needed before prescription (e.g dental checks for bisphosphonates).

QOF=quality and outcomes framework, DXA=dual-energy X-ray absorptiometry

References

  1. Svedbom A, Hernlund E, Ivergård M, et al. Osteoporosis in the European Union: a compendium of country-specific reports. Arch Osteoporos 2013; 8: 137.
  2. Compston J, Cooper A, Gregson C et al; National Osteoporosis Guideline Group. Clinical guideline for the prevention and treatment of osteoporosis. Arch Osteoporos (2017) 12: 43. Available at: www.sheffield.ac.uk/NOGG/NOGG%20Guideline%202017.pdf
  3. NICE. Osteoporosis: assessing the risk of fragility fracture. NICE Clinical Guideline 146. NICE, 2012 (updated February 2017). Available at: www.nice.org.uk/cg146
  4. Scottish Intercollegiate Guidelines Network. Management of osteoporosis and the prevention of fragility fractures. SIGN Guideline 142. SIGN, 2015. Available at: www.sign.ac.uk/assets/sign142.pdf
  5. NICE. Alendronate, etidronate, risedronate, raloxifene, strontium ranelate and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women. NICE Technology Appraisal 161. NICE, 2008. Available at: www.nice.org.uk/ta161
  6. NICE. Osteoporosis. NICE Quality Standard 149. NICE, 2017. Available at: www.nice.org.uk/qs149
  7. Kanis J, Oden A, Johnell O et al. The burden of osteoporotic fractures: a method for setting intervention thresholds. Osteoporosis Int 2001; 12: 417–427.
  8. Centre for Metabolic Bone Diseases. FRAX® Fracture risk assessment tool. University of Sheffield, 2008. www.sheffield.ac.uk/FRAX/tool.aspx?country=1 (accessed 1 June 2017).
  9. NICE Health and Social Care Directorate. Quality standard consultation—summary report. NICE, 2017. Available at: www.nice.org.uk/guidance/qs149/documents/consultation-summary-report
  10. National Osteoporosis Guideline Group. Intervention threshold. University of Sheffield, 2017. www.sheffield.ac.uk/NOGG/result-bmd.html (accessed 1 June 2017).
  11. Boulton C, Gallagher C, Javaid M et al. Fracture Liaison Service Database (FLS-DB) clinical audit—FLS forward: identifying high-quality care in the NHS for secondary fracture prevention. Royal College of Physicians, 2017. Available at: www.rcplondon.ac.uk/projects/outputs/fls-db-clinical-audit-identifying-high-quality-care-nhs-secondary-fracture
  12. BMJ Group, the Royal Pharmaceutical Society of Great Britain 2014. British National Formulary. NICE, 2017. www.evidence.nhs.uk/formulary/bnf/current (accessed 1 June 2017). 
  13. Li L, Roddam A, Gitlin M et al. Persistence with osteoporosis medications among postmenopausal women in the UK General Practice Research Database. Menopause 2012; 19 (1): 33–40. 
  14. NICE. Multimorbidity: clinical assessment and management. NICE Guideline 56. NICE, 2016. Available at: www.nice.org.uk/ng56
  15. Schnell S, Friedman S, Mendelson D et al. The 1-year mortality of patients treated in a hip fracture program for elders. Geriatr Orthop Surg Rehabil 2010; 1 (1): 6–14. G