Dr David Stephens summarises new recommendations from the updated SIGN guideline on the management of osteoporosis and prevention of fragility fractures

Dr David Stephens

Dr David Stephens

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Read this article to learn more about:

  • the definition, aetiology, and burden of osteoporosis
  • modifiable and non-modifiable risk factors for osteoporosis
  • targeting treatment on the basis of osteoporotic fracture risk.

Read this article at: GinP.co.uk/455573.article

Osteoporosis is a disease of bone formation that results in a reduction in the strength of bones and predominantly presents as fragility fracture in older women.1,2 Osteoporosis is caused by the microarchitectural deterioration of bone tissue, which leads to low bone mass and an increased risk of fractures.1,3 The condition is normally diagnosed by measuring bone density via dual-energy X-ray absorptiometry (DXA) scanning and calculation of a patient’s T-score, which equates to the difference in mean bone density between the patient and a healthy young woman.1,4 A diagnosis of osteoporosis can be made at 2.5 standard deviations below the mean bone density of a healthy young woman (T-score ≤ ­–2.5).1,5,6

It is estimated that around 180,000 fractures occur as a result of osteoporosis in England and Wales each year.7 Osteoporosis is thought to have similar morbidity to a range of other chronic non-communicable diseases, such as rheumatoid arthritis, asthma, and hypertension-related heart disease, but has a lower profile when it comes to diagnosis and treatment.8 People with hip fracture are at high risk of future fracture1 and have a high mortality—about 6% of people with a hip fracture die within 30 days.9

SIGN 142 on osteoporosis and fragility fractures

The Scottish Intercollegiate Guidelines Network (SIGN) has recently updated SIGN 142, first published in March 2015.1 The 2020 update includes new evidence on HIV as a risk factor and discussion of trials in targeting treatment through population screening. Sections on the use of pharmacological therapies zoledronic acid, denosumab, and parathyroid hormone have been updated, and a new section on romosozumab has been included. Recommendations for use of risedronate and zoledronic acid in men have also been added.

Although younger women and men can develop osteoporosis—especially those with certain characteristics (for example, a sedentary lifestyle, history of smoking, or high alcohol intake) or who take specific medications (for example, corticosteroids, proton pump inhibitors, and some sedatives)—the main group of patients with osteoporosis or a history of fragility fracture is women after the menopause.8 The update to SIGN 142 includes a revised algorithm that summarises the pathway for the assessment and treatment of postmenopausal women (see Figure 1).1

Pathway from risk factors to pharmacological treatment selection in postmenopausal women

Figure 1: Pathway from risk factors to pharmacological treatment selection in postmenopausal women over the age of 501

Scottish Intercollegiate Guidelines Network. Management of osteoporosis and the prevention of fragility fractures.  SIGN 142. Edinburgh: SIGN, 2015 (updated 2020). Available at: www.sign.ac.uk/our-guidelines/management-of-osteoporosis-and-the-prevention-of-fragility-fractures/ Reproduced with permission.

BMD=bone mineral density; DXA=dual-energy X-ray absorptiometry

Presentation and assessment

Osteoporosis is initially asymptomatic and often remains undiagnosed until a fragility fracture occurs.7 There are mainly two ways in which patients with osteoporosis present. Some patients present with a fragility fracture, which is often caused by mechanical forces that would not normally result in fracture (low-level trauma);1 these are commonly wrist or hip fractures. Patients can also present with vertebral fractures, which manifest acutely as severe back pain or asymptomatically on magnetic resonance imaging scanning or spinal X-ray.10

Fracture-risk assessment should be carried out, preferably using QFracture®, followed by a DXA scan if the patient has clinical risk factors for osteoporosis and anti-osteoporosis treatment is being considered.

Fracture-risk assessment should also be considered for people presenting with previous fractures, coexisting conditions, long-term use of certain drug therapies, or lifestyle risk factors, such as smoking (see Table 1).

Postmenospausal women who have experienced recent vertebral or hip fracture who cannot or are unwilling to take oral bisphosphonates may be started on treatment without bone mineral density (BMD) measurements, if obtaining the measurements is felt to be impractical.

Risk factors for osteoporosis

The SIGN guidance divides risk factors into non-modifiable, modifiable, coexisting diseases, and drug therapy (see Table 1). The update to SIGN 142 includes advice that people living with HIV are at increased risk of fracture and should be considered for a risk assessment. This advice is particularly important for those with several risk factors.1

Table 1: Risk factors associated with fragility fracture which should prompt consideration of fracture-risk assessment1
Risk categoryCausative factor

Non-modifiable risk factors

previous fracture

parental history of osteoporosis

history of early menopause (below age of 45)

Modifiable risk factors

low body mass index (<20 kg/m2)

smoking

low bone mineral density

alcohol intake

Coexisting diseases

diabetes

inflammatory rheumatic diseases (rheumatoid arthritis or systemic lupus erythematosus)

inflammatory bowel disease and malabsorption

institutionalised patients with epilepsy

human immunodeficiency virus

primary hyperparathyroidism and endocrine diseases

chronic liver disease

neurological diseases (including Alzheimer’s disease, Parkinson’s disease, multiple sclerosis, stroke)

moderate to severe chronic kidney disease

asthma

Drug therapy

long-term antidepressants

antiepileptics

aromatase inhibitors

long-term depot medroxyprogesterone acetate

gonadotropin-releasing hormone agonists (in men with prostate cancer)

proton pump inhibitors

oral glucocorticoids

thiazolidinediones

Scottish Intercollegiate Guidelines Network. Management of osteoporosis and the prevention of fragility fractures. SIGN 142. Edinburgh: SIGN, 2015 (updated 2020). Available at: www.sign.ac.uk/our-guidelines/management-of-osteoporosis-and-the-prevention-of-fragility-fractures/

Reproduced with permission

Diagnosis and management

The updated SIGN guideline recommends that bone density scanning at the spine and hip based on a BMD cut-off T-score of −2.5 is the method of choice for diagnosis of osteoporosis. There is insufficient evidence to support the use of peripheral BMD measurements, ultrasound densitometry, or biochemical markers in the diagnosis of fracture risk. In addition, SIGN examined new evidence around screening, and concluded that it does not reduce fracture risk.1,11,12

Following diagnosis, the guidance recommends that the relevant treatment options are discussed with the patient, and that the patient’s views and preferences are taken into account. This consultation should include discussion of the risks of fracture with and without treatment, use of tools such as QFracture® and FRAX®, risks and benefits of treatment, and the option to decline drug treatment. Consideration should be given to the patient’s ability and motivation to adhere to different treatments. When recommending assessment and treatment, the patient’s life expectancy and the anticipated duration of treatment should also be considered.

Treatment of osteoporosis is targeted based on BMD measurements and the presence of clinical risk factors. Strategies for the management of osteoporosis focus on the prevention of fragility fractures using pharmacological and non-pharmacological interventions.

Non-pharmacological interventions

Exercise of various types does slightly decrease the incidence of fracture and is recommended. A balanced diet is recommended, with additional vitamin D supplementation in winter in Scotland. Calcium and/or vitamin D supplementation is recommended for those whose dietary intake is insufficient, to reduce the risk of deficiency.1

Pharmacological management

Pharmacological treatments that decrease the incidence of fractures include parathyroid hormones, such as teriparatide, alendronic acid, risedronate, zoledronic acid, ibandronic acid, denosumab, and hormone replacement therapy—Box 1 outlines the new recommendations on treatment in the 2020 update.1

Box 1: New recommendations on pharmacological treatments from the updated SIGN guideline on Management of osteoporosis and the prevention of fragility fractures1

  • Zoledronic acid may be considered to reduce risk of clinical fractures in women over 65 years of age who have osteopenia at hip or femoral neck on DXA. The licensed regimen for zoledronic acid is annual 5 mg infusions, but infusions of the same dose every 18 months (off label) are also effective at reducing fracture risk
  • In postmenopausal women with at least two moderate or one severe low-trauma vertebral fractures, teriparatide is recommended over oral bisphosphonates, to prevent vertebral fracture
  • Romosozumab is a monoclonal antibody that binds to and inhibits sclerostin, thereby increasing bone formation and decreasing bone resorption. Romosozumab is given as a monthly dose of 210 mg subcutaneously for 12 months. Romosozumab has gained marketing authorisation for use in the UK, but a decision from the SMC on its use in NHSScotland is awaited before a recommendation can be made
  • Risedronate or zoledronic acid are options for the treatment of osteoporosis in men and for the prevention of fragility fractures
  • Treatment duration:
    • zoledronic acid (5 mg, intravenously) annually for 3 years is recommended in postmenopausal women with osteoporosis. The clinical benefit of annual zoledronic acid in preventing fractures beyond 3 years is uncertain
    • denosumab should be continued for 5 years for treatment of patients with osteoporosis and may be continued for up to 10 years in patients at high risk of fracture
  • Treatment discontinuation
    • following discontinuation of denosumab, transition to an antiresorptive therapy should be considered, with the aim of preventing the rebound increase in bone turnover
    • as teriparatide discontinuation is associated with bone loss, treatment with an antiresorptive agent should be considered to maintain the increase in bone density once a course of teriparatide has been completed.

Adapted from: Scottish Intercollegiate Guidelines Network. Management of osteoporosis and the prevention of fragility fractures.  SIGN 142. Edinburgh: SIGN, 2015 (updated 2020). Available at: www.sign.ac.uk/our-guidelines/management-of-osteoporosis-and-the-prevention-of-fragility-fractures/ Reproduced with permission.

Side-effects of treatment for osteoporosis

There are some serious side-effects of bone building treatment, but these are rare. Osteonecrosis of the jaw and atypical femoral fractures do occur, and it is important that these risks are carefully shared with patients. Good oral hygiene is recommended during bisphosphonate therapy and patients starting bisphosphonates should be advised to have a dental check-up as soon as possible.1 Bisphosphonates can occasionally cause oesophagitis; patients should be informed about the need to swallow tablets whole with a full glass of water and the importance of remaining upright (seated or standing) for at least 30 minutes after taking the medication.1

Summary

Fragility fractures, especially hip fractures, cause substantial mortality and morbidity which manifests as pain and disability, as well as a great financial cost. Treatment with antiresorptive and anabolic medication prevents some of these harms and needs to be prescribed and maintained in patients at high risk from a fracture. The 2020 update to SIGN 142 includes new recommendations on risk factors and pharmacological treatments to support clinicians to deliver best practice in the management of osteoporosis and prevention of fragility fractures.

Dr David Stephens

GP, Scotland

Member of the SIGN 142 guideline development group

Key points

  • Osteoporosis is defined as a T-score on a DXA scan of ≤ −2.5
  • Osteoporosis can present as a fragility fracture or during assessment for other chronic diseases
  • SIGN recommends the use QFracture® to calculate risk—SIGN does not make recommendations about the use of FRAX®, DXA with FRAX®, or the NOGG intervention thresholds
  • Measurement of BMD by DXA at the spine and hip should be carried out following fracture-risk assessment in patients in whom anti-osteoporosis treatment is being considered
  • People over the age of 50 with a history of fragility fractures should be offered DXA scanning to evaluate the need for anti-osteoporosis therapy
  • A balanced diet is recommended for bone health but there is no evidence that specific diets reduce fracture risk
  • Pharmacological management of osteoporosis is aimed at reducing the risk of fracture:
    • alendronic acid, risedronate, and zoledronic acid are recommended as treatment options to prevent vertebral fractures, non-vertebral fractures, and hip fractures in postmenopausal women with pre-existing vertebral fractures and/or DXA-proven osteoporosis
    • zoledronic acid is recommended to prevent further fractures in postmenopausal women with recent hip fractures who are unable or unwilling to take oral osteoporosis treatments, without undertaking BMD measurements if these are felt to be inappropriate or impractical
    • zoledronic acid may be considered to reduce risk of clinical fractures in women over 65 years of age who have osteopenia at hip or femoral neck on DXA
    • teriparatide is recommended to prevent vertebral and non-vertebral fractures in postmenopausal women with severe osteoporosis
    • in postmenopausal women with at least two moderate or one severe low-trauma vertebral fractures, teriparatide is recommended over oral bisphosphonates, to prevent vertebral fracture
    • zoledronic acid or risedronate are treatment options for the prevention of fragility fractures in men.

DXA=dual-energy X-ray absorptiometry; SIGN=Scottish Intercollegiate Guidelines Network; NOGG=National Osteoporosis Guideline Group; BMD=bone mineral density

The future of osteoporosis care

Commentary from Dr David Stephens (NB this is not discussed in the update to SIGN 142)

A fracture liaison service (FLS) is a bridge between secondary and primary care and is the most effective way of ensuring that patients with a fragility fracture start treatment promptly. CCGs and Health Boards where FLSs do not exist or are underdeveloped should put these in place to prevent further harm to their population. The RCP has an ongoing audit into the effectiveness of FLSs.13

With the advent of COVID-19, general practice is now much more a telephone and digital service. There is also less reliance on the GP, and more focus on a whole team approach. In future, a GP may not always be required to manage patients with osteoporosis who are moving back into primary care—a member of the primary care team, such as a practice pharmacist, advanced nurse practitioner, practice nurse, or musculoskeletal therapist, could take on this role. In addition, practices could appoint a Bone Health Lead to organise medication and review patients at 12–16 weeks, 12 months, and 3 years as stipulated by the NICE guidance,2 and provide the necessary support for patients with osteoporosis, especially when dealing with multimorbidity, polypharmacy, overdiagnosis, and concordance.

Implementation actions for STPs and ICSs

written by Dr David Jenner, GP, Cullompton, Devon

The following implementation actions are designed to support STPs and ICSs with the challenges involved with implementing new guidance at a system level. Our aim is to help you consider how to deliver improvements to healthcare within the available resources. 

  • Note that this guidance relates to Scotland, and that NICE and NOGG have both published differing guidance
  • Bear in mind that:
    • effective secondary prevention of fragility fractures can reduce morbidity and mortality 
    • there remains significant ambiguity over the ideal length of treatment for secondary prevention of osteoporosis, and the form and timing of review
    • there are small but significant risks associated with bone protection therapy especially atypical femoral fractures
  • Advise local health systems to establish multi-professional working groups to define local care pathways based on national guidance, to give those working in primary care clarity among the differing guidance
  • Identify cost-effective pharmacotherapies and indications for their use
  • Consider establishing an advice and guidance service for the management of osteoporosis to support healthcare professionals and patients with individualised approaches to treatment.

STP=sustainability and transformation partnership; ICS=integrated care system; ICS=integrated care system; NOGG=National Osteoporosis Guideline Group

Implementation actions for clinical pharmacists in general practice

written by Nicola Cree, Pharmaceutical Services Manager, Soar Beyond Ltd

The following implementation actions are designed to support clinical pharmacists in general practice with implementing the guidance at a practice level.

Osteoporosis management sits perfectly within the clinical pharmacist’s professional remit. Poor long‑term outcomes, coupled with poor adherence, offer pharmacists the prime opportunity to facilitate quality improvement in osteoporosis care.

  • Conduct structured medication reviews for patients who have had a recent fall, as emphasised by the PCN DES;[A] many of these will be on (or require initiation of) anti-osteoporotic medications
  • Audit to identify baseline metrics. A cause and effect analysis can also help identify areas for improvement in individual practices where the clinical pharmacist can focus their attention
  • Identify patient cohorts that a pharmacist-led service could manage, including:
    • supporting adherence and medicines optimisation in postmenopausal women
    • patients with recent fracture
    • patients with known non-adherence
  • Perform osteoporosis patient reviews, potentially covering:
    • treatment adherence
    • medicines advice, including adverse effects
    • diet and exercise advice
    • falls and fracture assessment
    • patient understanding of why they’re taking the medicines
    • appropriate prescribing and deprescribing.

Guidance and training for service development is available for a number of different clinical areas from Soar Beyond. If you have clinical pharmacists in your practice or organisation, contact Soar Beyond to see how they can support with clinical delivery, training, and development: soarbeyond.co.uk

NHS England, NHS Improvement. Network contract Directed Enhanced Service: contract specification 2020/21—PCN requirements and entitlements. NHS England, March 2020. Available at: www.england.nhs.uk/wp-content/uploads/2020/03/network-contract-des-specification-pcn-requirements-entitlements-2020-21.pdf

PCN=Primary Care Network; DES=Directed Enhanced Service

References

1. Scottish Intercollegiate Guidelines Network. Management of osteoporosis and the prevention of fragility fractures. SIGN 142. Edinburgh: SIGN, 2015 (updated 2020). Available at: www.sign.ac.uk/media/1741/sign142.pdf

2. NICE. Osteoporosis: assessing the risk of fragility fracture. Clinical Guideline 146. NICE, 2012 (updated 2017). Available at: www.nice.org.uk/cg146

3. Consensus development conference: diagnosis, prophylaxis, and treatment of osteoporosis. Am J Med 1993; 94 (6): 646–650.

4. Kanis J; WHO Scientific Group Technical Report. Assessment of osteoporosis at the primary health care level—report of a WHO scientific group. Geneva: WHO, 2007. Available at: www.iofbonehealth.org/sites/default/files/WHO_Technical_Report-2007.pdf

5. Schousboe J, Shepherd J, Bilezikian J, Baim S. Executive summary of the 2013 International Society for Clinical Densitometry Position Development Conference on bone densitometry. J Clin Densitom 2013; 16 (4): 455–466.

6. Kanis J, Gluer C. An update on the diagnosis and assessment of osteoporosis with densitometry. Committee of Scientific Advisors, International Osteoporosis Foundation. Osteoporos Int 2000; 11 (3): 192–202.

7. NICE. Osteoporosis—prevention of fragility fractures. Clinical Knowledge Summary. cks.nice.org.uk/osteoporosis-prevention-of-fragility-fractures#!scenario:1 (accessed 3 August 2020).

8. International Osteoporosis Foundation. Facts and statistics. www.iofbonehealth.org/facts-statistics#category-14 (accessed 3 August 2020).

9. Royal College of Physicians. National Hip Fracture Database: annual report 2019. Available at: www.nhfd.co.uk/files/2019ReportFiles/NHFD_2019_Annual_Report_v101.pdf

10. Fink H, Milavetz D, Palermo L et al. What proportion of incident radiographic vertebral deformities is clinically diagnosed and vice versa? J Bone Miner Res 2005; 20: 1216–1222.

11. Rothmann M, Moller S, Holmberg T et al. Non-participation in systematic screening for osteoporosis-the ROSE trial. Osteoporos Int 2017; 28 (12): 3389–3399.

12. Shepstone L, Lenaghan E, Cooper C et al. Screening in the community to reduce fractures in older women (SCOOP): a randomised controlled trial. Lancet 2018; 391 (10122): 741–747.

13. Royal College of Physicians. Fracture Liaison Service Database (FLS-DB). Available at: www.rcplondon.ac.uk/projects/fracture-liaison-service-database-fls-db (accessed 21 August 2020).