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This promotional supplement has been commissioned by Amgen and developed in partnership with Guidelines in Practice. See below for full disclaimer.

Information for UK healthcare professionals only.

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Webinar summary—Fragility fractures and osteoporosis: a public health imperative in improving outcomes for patients 

Chair: Dr Adrian Hayter, National Clinical Director for Older People and Person-centred Integrated Care, NHS England

Speakers: Professor Cyrus Cooper, Professor of Rheumatology and Director, MRC Lifecourse Epidemiology Unit, University of Southampton; Professor of Epidemiology, University of Oxford, UK; President, International Osteoporosis Foundation; Craig Jones, Chief Executive, Royal Osteoporosis Society; Dr Sunil Nedungayil, GP and Associate Medical Director, Northern Health Science Alliance

A webinar hosted by Govconnect, sponsored by Amgen, and chaired by Dr Adrian Hayter held on 8 June 2021 aimed to support healthcare professionals to improve care for patients with fragility fractures and osteoporosis.  

Professor Cyrus Cooper described the mortality and morbidity burden attributable to osteoporotic fractures. Although validated risk assessment is incorporated into guidelines, and primary and secondary prevention strategies are effective and cost effective, a treatment gap remains, with many patients at risk of fracture not receiving treatment in primary care.  

Craig Jones described the devastating impact of osteoporosis on patients’ lives. However, the condition is often under-estimated, opportunities to improve bone health are missed, and only 55% of people have access to fracture liaison services (FLS). The Royal Osteoporosis Society is calling for 100% access to FLS, digital tools in primary care to prevent first fractures, coherent pathways of care and prevention, and increased research funding.  

Dr Sunil Nedungayil described the Northern Bone Health Project—an innovative approach to reduce the risk of older people breaking bones. The project identifies patients at high risk of fracture, evaluates medications, and treats patients, where appropriate, with a bone-sparing agent to improve bone density. 

For more information on this webinar, please contact Amgen at bonehealth@amgen.com

Patient consultation guide—supporting the management of patients with osteoporosis 

Author: Dr Sunil Nedungayil, GP and Associate Medical Director, Northern Health Science Alliance

Reviewed by: Professor Cyrus Cooper, Professor of Rheumatology and Director, MRC Lifecourse Epidemiology Unit, University of Southampton; Professor of Epidemiology, University of Oxford, UK; President, International Osteoporosis Foundation; Dr Adrian Hayter, National Clinical Director for Older People and Person-centred Integrated Care, NHS England; Craig Jones, Chief Executive, Royal Osteoporosis Society

Introduction

Osteoporosis occurs when the body loses too much and/or makes too little bone.1 Bones consequently become weak and may break from a fall or, in serious cases, from minor bumps or even sneezing.1 Osteoporosis-related fractures are known as fragility fractures (Box 1).2,3 Fragility fractures are fractures that occur from events that would not ordinarily result in fracture.2,3

More than 3 million people in the UK are estimated to have osteoporosis.4 The prevalence increases dramatically with age, increasing from 2% in women aged 50 years to more than 25% in those aged >80 years.2,5 The risk of fracture also increases with advancing age and progressive loss of bone mass,6 with one in two women and one in five men aged >50 years expected to break a bone.7 About 30% of people aged ≥65 years and 50% of those aged >80 years have a fall at least once a year, and in 5% of falls, the individual develops a fracture and requires hospitalisation.8 Despite 255,000 fall-related emergency hospital admissions in England among patients aged ≥65 years,8 many more people have a fall and are not admitted.9

In the UK during 2010, approximately 536,000 new fragility fractures were sustained, comprising 79,000 hip fractures, 66,000 vertebral fractures, 69,000 forearm fractures, and 322,000 other fragility fractures in other sites.4 Sustaining a fragility fracture at least doubles the risk of a future fracture.10

Falls, osteoporosis, and associated fractures have a major impact on patients’ quality of life. Older individuals who have fallen and those who have not have increased prevalence of fear of falling, which can result in activity avoidance, social isolation, and increasing frailty.8   A quarter of working-age people with osteoporosis have to give up work, change job, or reduce their hours.11 Hip fracture leads to a significant loss of healthy life years, with 27 disability-adjusted life-years (DALY) per 1,000 lost after hip fractures in people aged ≥50 years.12 One year after hip fracture, 40% of patients are still unable to walk independently; 60% have difficulty with at least one essential activity of daily living, such as eating, dressing, and personal hygiene; 80% are restricted in other activities, such as driving and grocery shopping; and 27% enter a nursing home for the first time.6 More than one in four people (28.7%) die within a year of suffering a hip fracture.13

Emergency admissions due to falls in people aged ≥65 years cost the NHS more than £2.3 billion annually.9 More than 500,000 people present with fragility fractures to hospital in the UK each year, with an estimated annual cost of £4.4 billion to the NHS; hip fractures alone cost around £2 billion a year.9

With the number of people aged ≥65 years projected to rise by over 40% to more than 16 million in the next 17 years,8 the incidence, prevalence, burden, and costs associated with osteoporosis, fragility fractures, will only increase further. They are thus a public health imperative, and falls prevention, detecting and managing osteoporosis, and optimal support after fragility fractures are the three priorities for optimisation in the RightCare Falls and Fragility Fractures Pathway,14 with falls and fragility fractures also included in the NHS RightCare Frailty Toolkit.15 However, despite the significant associated burden, osteoporosis, fragility fractures, and falls are often underdiagnosed and undermanaged. For example, one fifth of women who have broken a bone will break three or more before being diagnosed with osteoporosis,16 less than one‑third of people with fragility fractures receive bone‑protecting treatments,14 and 80% of those who have a non‑hip fracture are not offered strength and balance exercises.14

This supplement draws on multiple sources that consider the management of osteoporosis, fragility fractures, falls, and frailty in the UK to provide guidance on their identification, prevention, and management, including when to move to second-line therapy.

Box 1

Identification and diagnosis 

All patients with osteoporosis and at risk of fragility fractures and falls should be identified, so that treatment can be initiated early. The diagnosis should be recorded in the osteoporosis register to ensure regular and appropriate follow-up.

Who to screen 

These considerations will help the clinicians to identify ‘at risk’ patients and minimise any missed opportunities to diagnose osteoporosis.

  • All patients discharged from hospital following a fracture should be assessed to determine whether it was a fragility fracture (see Box 1)  
  • All women aged ≥65 years and men ≥75 years2,17
  • Opportunistic screening as part of well woman/man screening or on attending primary care for an unrelated condition
  • Women aged <65 years, post-menopausal women, men <75 years and men ≥50 years with risk factors for fracture (Table 1)2,17,18
  • Patients starting treatments that may have a rapid adverse effect on bone density (e.g. sex hormone deprivation for breast or prostate cancer)2,17
  • Women and men aged <70 years taking high doses of glucocorticoids*18  
  • Vertebral fracture risk in postmenopausal women and men aged >50 years with ≥4 cm height loss, kyphosis, recent or current long-term oral glucocorticoid therapy, or BMD T-score ≤–2.5.18

*Equivalent to ≥7.5 mg/day prednisolone.

Table 1

How to screen 

  • Estimate 10-year predicted absolute fracture risk using FRAX—without bone mineral density (BMD) if a dual-energy X-ray absorptiometry (DXA) scan has not previously been undertaken—or QFracture within allowed age ranges2,17
  • Use FRAX for: 
    • people aged 40–90 years, with or without BMD values17
      • consider individuals above the upper age limits as at high risk2,17
    • postmenopausal women and men aged ≥50 years with risk factors17
    • women and men aged <70 years taking high doses of glucocorticoids*, with adjustment for glucocorticoid dose17
  • Use Qfracture for people aged 30–84 years (BMD values cannot be incorporated)17
    • Consider individuals above the upper age limits as at high risk2,17
  • Do not routinely measure BMD to assess fracture risk without prior assessment using FRAX (without a BMD value) or QFracture2,17
    • use BMD in people aged <40 years with a major risk factor (see Table 1)2,17
    • consider measuring BMD before starting treatments that may have a rapid adverse effect on bone density (e.g. sex hormone deprivation for breast or prostate cancer).2,17
    • for people with fracture risk in the region of an intervention threshold following assessment with FRAX (without BMD value) or QFracture and those at intermediate risk, consider measuring BMD with DXA and recalculating absolute risk using FRAX with BMD2,17,18
  • Interpret estimated absolute risk of fracture in people aged >80 years with caution, because predicted 10-year fracture risk may underestimate short-term fracture risk.2,17

*Equivalent to ≥7.5 mg/day prednisolone.

Administration  

  • Record patients diagnosed with osteoporosis or a fragility fracture in the primary care osteoporosis register so they can be easily identified and followed up appropriately. Use the up-to-date QOF Business rules to arrive at the right code for the condition.

Management  

Primary prevention should be started in patients newly diagnosed with osteoporosis or at high risk of a fragility fracture and secondary prevention in patients with a confirmed fragility fracture. Advice on non-pharmacological and lifestyle measures should be offered to all patients with osteoporosis or a history or risk of fragility fractures. Figure 1 provides an algorithm summarising the management of patients with osteoporosis, high fracture risk, and fragility fractures based on current guidance and clinical expertise.

Figure 1

Non-pharmacological management  

  • Recommend daily calcium intake of 700–1,200 mg through dietary intake, if possible, or supplements18  
  • In postmenopausal women and men aged ≥50 years at increased risk of fracture, recommend 800 IU/day cholecalciferol18 
  • In postmenopausal women and older men receiving bone protective therapy for osteoporosis:18  
    • recommend calcium supplementation for dietary intake <700 mg/day  
    • consider vitamin D supplementation in those at risk of or with evidence of vitamin D insufficiency 
  • Recommend regular weight-bearing exercise, tailored according to the needs and abilities of the individual patient18  
  • Obtain a falls history in individuals at increased risk of fracture and undertake further assessment and appropriate measures in those at risk, including strength and balance exercise programmes, which have been shown to reduce the rate of falls.14,18

Pharmacological management  

  • Box 2 summarises the drugs available for management of osteoporosis and fragility fractures. First-line treatment typically involves the oral bisphosphonates alendronic acid, ibandronic acid, and risedronate sodium.18,19 Intravenous ibandronic acid and zoledronic acid, teriparatide, and denosumab may be used first-line in specific circumstances and for second-line treatment.18.19 Treatment should be chosen on an individual basis after discussion with the patient or their carers about the advantages and disadvantages of available treatments.19 If several generic products are available, start with the least expensive formulation, taking into account administration costs, dose needed, and cost per dose.19 The importance of adherence should be emphasised to the patient. 

Box 2

First-line treatment 

Primary prevention 

  • Adults eligible for risk assessment with a 10-year probability of osteoporotic fragility fracture ≥1%:19  
    • oral bisphosphonates19  
    • alendronic acid or risedronate in most postmenopausal women and in men18  
  • Adults with 10-year probability of osteoporotic fragility fracture ≥10%: 
    • intravenous bisphosphonates19
  • When oral bisphosphonates are contraindicated: 
    • intravenous bisphosphonates for adults with 10-year probability of osteoporotic fragility fracture ≥1%22  
    • women:18  
      • subcutaneous denosumab or intravenous bisphosphonates
      • raloxifene or hormone replacement therapy are additional options 
      • high cost of teriparatide restricts its use to those at very high risk, particularly for vertebral fractures  
    • men:18  
      • denosumab or zoledronic acid
      • teriparatide is an additional option 
  • For women and men aged ≥70 years taking high doses of glucocorticoids*:18  
    • start alendronic acid or risedronate at onset of glucocorticoid therapy in individuals at high risk of fracture18 

*Equivalent to ≥7.5 mg/day prednisolone.

Secondary prevention 

  • Alendronic acid or risedronate for:18  
    • women and men aged ≥70 years with a previous fragility fracture  
    • premenopausal women and younger men with a previous history of fracture
  • Consider denosumab for patients intolerant to bisphosphonates.

Initial medication review  

Arrange initial medication review for patients newly started on bone-protective therapy due to osteoporosis or a risk of fragility fractures:  

  • Most medication reviews in primary care may be undertaken by nurses, clinical pharmacists, or musculoskeletal physiotherapists with appropriate training and competencies  
    • For complex cases, including other medical conditions, polypharmacy leading to potential drug interactions, and kidney dysfunction or failure, a specialist GP should be involved, or the advice of secondary care bone health clinician should be sought 
  • Check that patients have been recorded on the osteoporosis register  
  • Check for comorbidities or concomitant medications that may interfere with efficacy: 
    • For example, alendronic acid may be associated with reflux19 and should be withdrawn rather than prescribing proton pump inhibitors  
  • Check compliance and ask about side-effects with initial treatment: 
    • If compliance is good and the patient reports no troublesome side effects, continue treatment and ensure it is added to their repeat prescriptions 
    • If compliance is poor or the patient is experiencing troublesome side effects, switch the patient to a second‑line treatment.  

Second-line treatment 

Patients with poor compliance and those experiencing troublesome side effects should be switched to second-line treatment: 

  • Intravenous bisphosphonates for adults with 10-year probability of osteoporotic fragility fracture ≥1% with difficulty taking oral bisphosphonates19  
  • When bisphosphonates are not tolerated: 
    • intravenous bisphosphonates for adults with 10-year probability of osteoporotic fragility fracture ≥1%19  
    • women:18  
      • subcutaneous denosumab or intravenous bisphosphonates 
      • raloxifene or hormone replacement therapy are additional options 
      • high cost of teriparatide restricts its use to those at very high risk, particularly for vertebral fractures  
    • men:18  
      • subcutaneous denosumab or zoledronic acid
      • teriparatide is an additional option 
  • Zoledronic acid, denosumab, and teriparatide are alternatives for bone-protective therapy in women and men aged ≥70 years taking high doses of glucocorticoids* in whom alendronate or risedronate are not tolerated18  

*Equivalent to ≥7.5 mg/day prednisolone.

Ongoing review 

Patients should be reviewed regularly:18 

  • Arrange medication review every 3–6 months to check compliance and side effects18  
  • Consider specialist review if the patient sustains a fracture after one year on treatment  
  • Continuation of treatment should be reviewed after 3 years of zoledronic acid therapy and 5 years of oral bisphosphonates and denosumab:18  
    • Continuation of bisphosphonates and denosumab beyond 3–5 years can generally be recommended in individuals aged ≥75 years, those with a history of hip or vertebral fracture, those who sustain a fracture while on treatment, and those taking oral glucocorticoids18  
    • If treatment is discontinued, fracture risk should be reassessed after a new fracture, regardless of when this occurs18  
    • If no new fracture occurs, assessment of fracture risk should be performed again after 18 months to 3 years21  
    • No evidence to guide decisions beyond 10 years of treatment so management should be considered on an individual basis.18 However osteoporosis is a chronic condition and may require long term therapy
    • The optimal total duration of antiresorptive treatment for osteoporosis (including both denosumab and bisphosphonates) has not been established. The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of denosumab on an individual patient basis, particularly after 5 or more years of use.

Key messages

Useful resources:

Conflicts of interest

The author and reviewers have received an honorarium to develop this supplement. The author and reviewers have also received consultancy fees from other pharmaceutical companies, which may include Amgen, for activities other than the development of this supplement.

References 

  1. Bone Health and Osteoporosis Foundation. What is osteoporosis and what causes it? www.bonehealthandosteoporosis.org/patients/what-is-osteoporosis/ (accessed February 2022)
  2. NICE. Osteoporosis: assessing the risk of fragility fracture. Clinical Guideline 146. NICE, 2012 (last updated February 2017). www.nice.org.uk/guidance/cg146  
  3. International Osteoporosis Foundation. Fragility Fractures. www.osteoporosis.foundation/health-professionals/fragility-fractures (accessed February 2022)
  4. Svedbom A, Hernlund E, Ivergård M, et al. Osteoporosis in the European Union: a compendium of country-specific reports. Arch Osteoporosis 2013; 8: 137. 
  5. International Longevity Centre UK. Osteoporosis in the UK…at breaking point. ILCUK, 2010. Available at: https://ilcuk.org.uk/osteoporosis-in-the-uk-at-breaking-point/ 
  6. Cooper C. The crippling consequences of fractures and their impact on quality of life. Am J Med 1997; 103: S12–S19. 
  7. Royal Osteoporosis Society. Effective Secondary Prevention of Fragility Fractures: Clinical Standards for Fracture Liaison Services. ROS, 2019. Available at: https://theros.org.uk/media/1eubz33w/ros-clinical-standards-for-fracture-liaison-services-august-2019.pdf 
  8. Public Health England. Falls and fragility fractures consensus statement: supporting commissioning for prevention. PHE, 2017. Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/586382/falls_and_fractures_consensus_statement.pdf  
  9. NICE. NICE impact: falls and fragility fractures. NICE, 2018. www.nice.org.uk/media/default/about/what-we-do/into-practice/measuring-uptake/nice-impact-falls-and-fragility-fractures.pdf  
  10. British Geriatrics Society. The care of patients with fragility fracture (Blue Book). BGS, 2007. Available at: www.bgs.org.uk/resources/care-of-patients-with-fragility-fracture-blue-book 
  11. National Osteoporosis Society. Life with Osteoporosis: the untold story Key findings from research into the realities of life with osteoporosis. NOS. 2014. Available at: www.laterlifetraining.co.uk/wp-content/uploads/2014/10/NOS-Public-Report-V2.2-Small-file-size.pdf
  12. Papadimitriou N, Tsilidis KK, Orfanos P, et al. Burden of hip fracture using disability-adjusted life-years: a pooled analysis of prospective cohorts in the CHANCES consortium. Lancet Public Health 2017; 2: e239–e246. 
  13. Neuburger J, Currie C, Wakeman R, et al. The impact of the national clinician-led audit initiative on care and mortality after hip fracture in England: an external evaluation using time trends in non-audit data.Med Care 2015;53: 686–691. 
  14. NHS. RightCare Pathway: Falls and Fragility Fractures. NHS, 2017. Available at: www.england.nhs.uk/rightcare/wp-content/uploads/sites/40/2017/12/falls-fragility-fractures-pathway-v18.pdf 
  15. NHS. NHS RightCare: Frailty Toolkit Optimising a frailty system. NHS, 2019. Available at: www.england.nhs.uk/rightcare/wp-content/uploads/sites/40/2019/07/frailty-toolkit-june-2019-v1.pdf
  16. Royal Osteoporosis Society. State of the nation report: vertebral facture identification in 2021. ROS, 2021. Available at: https://strwebprdmedia.blob.core.windows.net/media/fcodhs1m/state-of-the-nation-report-vertebral-fracture-identification-in-2021.pdf  
  17. NICE. Osteoporosis: assessing the risk of fragility fracture. NICE, 2021. Available at: https://pathways.nice.org.uk/pathways/osteoporosis#path=view%3A/pathways/osteoporosis/osteoporosis-assessing-the-risk-of-fragility-fracture.xml&content=view-index
  18. National Osteoporosis Guideline Group. NOGG 2017: Clinical guideline for the prevention of and treatment of osteoporosis. NOGG, 2018. Available at: www.sheffield.ac.uk/NOGG/NOGG%20Guideline%202017.pdf  
  19. NICE. Osteoporosis overview. NICE, 2021. Available at: https://pathways.nice.org.uk/pathways/osteoporosis 
  20. Accord Healthcare Limited. Alendronic acid once weekly 70 mg tablets—summary of product characteristics. www.medicines.org.uk/emc/product/6052/smpc (accessed February 2022)
  21. Sandoz Limited. Ibandronic acid 150 mg film-coated tablets—summary of product characteristics. www.medicines.org.uk/emc/product/4135/smpc (accessed February 2022)  
  22. Sandoz Limited. Risedronate sodium 35 mg film-coated tablets—summary of product characteristics. www.medicines.org.uk/emc/product/4767/smpc (accessed February 2022)   
  23. Accord UK Ltd. Ibandronic acid 3 mg solution for injection—summary of product characteristics. www.medicines.org.uk/emc/product/6995/smpc (accessed February 2022)
  24. Ranbaxy (UK) Limited. Zoledronic acid 5 mg solution for injection—summary of product characteristics. www.medicines.org.uk/emc/product/5242/smpc (accessed February 2022)
  25. Amgen Ltd. Prolia (denosumab)—summary of product characteristics. www.medicines.org.uk/emc/product/568/smpc (accessed February 2022) 
  26. Accord UK Ltd. Raloxifene hydrochloride 60mg film-coated tablets—summary of product characteristics. www.medicines.org.uk/emc/product/6882/smpc (accessed February 2022)  
  27. Eli Lilly and Company Limited. Forsteo 20 micrograms/80 microlitres solution for injection in pre-filled pen—summary of product characteristicswww.medicines.org.uk/emc/product/2215/smpc (accessed February 2022)
  28. UCB Pharma Limited. EVENITY 105 mg solution for injection in pre-filled pen—summary of product characteristics. www.medicines.org.uk/emc/product/10956/smpc (accessed February 2022)

This promotional supplement has been commissioned by Amgen and developed in partnership with Guidelines in Practice. Amgen suggested the topic and author, the reviewers, and carried out full approval on all materials to ensure compliance with regulations. Amgen paid an honorarium to the author and reviewers. The views and opinions of the author are not necessarily those of Amgen, Guidelines in Practice, its publisher, advisers, or advertisers. No part of this publication may be reproduced in any form without the permission of the publisher.

GB-PRO-0222-00032

Date of preparation: March 2022