g logo wp yellow

In this summary

 

This guideline was developed by a multidisciplinary expert panel: Cooper C et al with the support of an educational grant from UCB Pharma Ltd. See bottom of page for full disclaimer.

Introduction

Osteoporosis is a disease characterised by low bone mass and structural deterioration of bone tissue, increasing bone fragility and susceptibility to fracture. Reduced bone density is the major risk factor for fragility fracture, but other factors also increase the risk (Box 1).

Box 1: Risk factors for fragility fractures

  • Previous fragility fracture 
  • Current or frequent recent use of oral or systemic glucocorticoids 
  • Increasing age 
  • Female sex/menopause
  • Causes of secondary osteoporosis 
  • Low body mass index (<18.5 kg/m2
  • History of falls 
  • Parental history of hip fracture 
  • Smoking 
  • Alcohol intake >14 units per week.

In 2019, Kanis et al published an algorithm for the management of patients at low, high, and very high risk of osteoporotic fractures based on the FRAX risk assessment tool. A study has demonstrated that FRAX and other fracture risk prediction tools may underestimate fracture risk in the first two years post fracture, the imminent fracture period. Hence, the need to incorporate the recency of fracture with scores for fracture risk at an individual level. This working party guideline covers the management of patients at low, high, and very high risk of osteoporotic fracture and is intended for healthcare professionals who interact with these patients.

Treatment of osteoporosis 

Preventative treatment given as soon as possible after a fragility fracture will reduce the number of subsequent fractures and morbidity compared with delayed treatment. Lifestyle modifications provide a non-pharmacological approach for all patients with osteoporosis and are the first option for those at lowest risk (Box 2).

Box 2: Lifestyle modifications to improve bone health

  • Recommend for all patients irrespective of risk 
  • Modifications include: 
    • exercise 
    • diet, including adequate calcium/vitamin D intake
    • reducing the risk of falls
    • stopping smoking
    • reducing alcohol intake to ≤2 units/day
  • Tailor recommendations to each patient’s own circumstances and comorbidities
  • All patients with osteoporosis should exercise using ‘strong, steady, and straight’ guidance to:
    • promote bone strength
    • improve balance and muscle strength to reduce falls and resulting fractures
    • care for the spine by keeping the back straight to reduce the risk of vertebral fracture, and improve posture and relieve pain after vertebral fracture.

Pharmacological treatments for those at higher risk fall into two categories—antiresorptive agents and bone-forming (anabolic) agents (Box 3).

Box 3: Drugs available to treat osteoporosis[A]

  • Antiresorptive
    • bisphosphonates:
      • alendronate
      • risedronate
      • ibandronic acid (oral or injection)
      • zoledronic acid (IV)
    • raloxifene (in women only)
    • denosumab (injection)
    • hormone replacement therapy (menopausal women/testosterone replacement in male hypogonadism)
  • Bone forming (anabolic)
    • teriparatide (self-injected)
    • biosimilar teriparatide (self-injected)
    • romosozumab (injection).

[A] Prescribers should refer to the individual summaries of product characteristics.

IV=intravenous

Risk assessment 

Risk assessment is vital so that anti-osteoporosis medication (AOM) can be started as early as possible. Current NICE guidance recommends two risk assessment tools to predict the probability of a future fragility fracture—FRAX and QFracture. The Scottish Intercollegiate Guidelines Network (SIGN) recommends fracture risk assessment preferably using QFracture. The online FRAX risk-assessment tool allows calculation of the 10-year absolute risk of hip fracture and other major osteoporotic fractures (clinical spine, forearm, hip, or shoulder fracture). While the initial FRAX assessment does not have to include measurement of bone mineral density (BMD), a strength of the tool is that BMD measurements can be included in the assessment if available and input into the National Osteoporosis Guideline Group (NOGG) tool to indicate when AOM should be considered. QFracture is also an online fracture risk scoring tool that can be used to predict the absolute risk of hip fracture and of major osteoporotic fractures (spine, wrist, hip, or shoulder) over 1–10 years.

Both NICE and SIGN advise GPs not to routinely measure BMD to assess fracture risk without prior assessment using FRAX (without a BMD value) or QFracture. NICE recommends assessing fracture risk in all women aged ≥65 years and men aged ≥75 years, as well as younger women and men who have risk factors (see Box 1). SIGN recommends fracture risk assessment, preferably using Qfracture, prior to measuring BMD in patients with clinical risk factors for osteoporosis and in whom AOM is being considered; they propose a 10-year fracture risk of 10% as the level at which measurement of BMD is appropriate in people who have not previously had a fragility fracture. NICE recommends measurement of BMD to assess fracture risk in people younger than 40 years with a major risk factor, such as history of multiple fragility fractures, major osteoporotic fracture, or current or recent use of high-dose oral or systemic glucocorticoids (more than 7.5 mg prednisolone or equivalent per day for 3 months or longer).

The algorithm published by Kanis et al suggests further development of FRAX risk assessment by combining the FRAX score with BMD measurements to refine characterisation of risk by categorising patients as at low, high, or very high risk of osteoporotic fracture in order to guide treatment decisions and direct appropriate interventions.

UK consensus management of patients at low, high, and very high risk of osteoporotic fracture

A working party group was convened to develop a consensus guideline and treatment algorithm to support primary care in the management of patients at low, high, and very high risk of osteoporotic fracture. Figure 1 provides an algorithm summarising the group’s consensus recommendations for management of patients in these three risk groups.

Figure 1_Algorithm on the management of patients at risk of osteoporotic fracture

Figure 1: Algorithm on the management of patients at low, high, and very high risk of osteoporotic fracture

Identification of patients at risk of osteoporotic fracture 

  • Patients at risk of osteoporotic fracture include:
    • patients with a recent (in the last 2 years) fragility fracture
      • major fractures of hip/pelvis/femur
      • distal forearm
      • vertebra
      • proximal humerus
      • rib
      • clavicle
      • tibia
    • patients identified as at risk of future fracture through opportunistic screening
    • patients at risk of future fracture due to treatments such as steroids or other bone damaging medicines.

Assessing the level of future risk 

  • The level of future risk should be assessed through FRAX or QFracture, according to local or national guidelines, and also take into consideration clinical features such as the site and recency of previous fractures that are not included in the risk calculation for FRAX and QFracture
    • note that FRAX but not QFracture outputs are compatible with the fracture probability nomograms in the Kanis et al algorithm or NOGG guidance
    • the SIGN guideline proposes a 10-year fracture risk of 10% as the level at which measurement of BMD is appropriate in people who have not previously had a fragility fracture and treatment should then be based on the BMD measurement
    • note that the FRAX/NOGG thresholds and the SIGN recommendation are based on expert recommendation.

Managing patients based on their future risk 

  • Lifestyle modifications should be recommended for all patients irrespective of their level of risk (see Box 2)
  • Choice of pharmacological treatment (see Box 3) varies based on the level of risk
    • the future risk of fractures is a continuum from low risk through high risk to very high risk rather than discrete risk categories
      • if a patient is close to the threshold between two levels of risk, individual patient factors should be considered when deciding on treatment options
    • good prescribing practice means that treatment in primary care often starts with a medication that has been available for some time and where the prescriber has clinical experience with the drug and any possible adverse effects
      • an individualised decision should be made for each patient based on their medical history, their level of fracture risk in the next 2 years, and the experience of the prescriber; specialists can help with treatment decisions in high risk patients, especially if the patient has previously been prescribed AOM.

Low risk 

  • Patients at low risk should be reassured and require only lifestyle modifications (see Box 2)
    • provide patient information leaflets and advice on circumstances that mean they may need to seek further assessment
  • Follow up if additional risk factors develop.

High risk 

  • Patients at high risk of future fracture should be prescribed antiresorptive agents before referral for bone-forming drugs: 
    • prescribe alendronate, risedronate, ibandronic acid, raloxifene, denosumab, or hormone replacement therapy
    • refer to specialist service for intravenous zoledronic acid, teriparatide, biosimilar teriparatide, or romosozumab
  • Sequence of therapy should be planned with a bone specialist unit
  • Primary care follow-up:
    • ensure treatment has been initiated and advice on lifestyle modifications has been given
      • advice on lifestyle modifcations should be repeated at each consultation
    • check adherence to antiresorptive agents and whether bone-forming drugs are required in high risk patients within 4 months and at 12 months, including:
      • tolerability 
      • new cautions and contraindications 
      • calcium/vitamin D intake 
      • change in fracture and falls risk
    • continue to review medication and adherence annually and after 3 years assess the level of future risk through FRAX or QFracture (and measure BMD if required) according to local or national guidelines
      • practice-based pharmacists may undertake annual reviews as part of a medicines optimisation review and repeat prescribing; liaison with community pharmacists will enhance patient care.

Very high risk 

  • Very high (or imminent) risk is defined by a high FRAX score with a history of major fracture of the hip/pelvis/femur, vertebra, humerus, or ribs in the last 2 years
  • Patients at very high risk of future fracture should be prescribed bone-forming (anabolic) drugs: 
    • consider urgent referral to specialist service for teriparatide, biosimilar PTH, or romosozumab; urgent treatment will require the development of new primary and secondary care pathways
  • Sequence of therapy should be planned with a bone specialist unit
  • Primary care follow-up: 
    • ensure treatment has been initiated and advice on lifestyle modifications has been given
      • advice on lifestyle modifcations should be repeated at each consultation
    • check adherence within 4 and at 12 months, including:
      • tolerability 
      • new cautions and contraindications 
      • calcium/vitamin D intake 
      • change in fracture and falls risk
    • continue to review medication and adherence annually and after 3 years assess the level of future risk through FRAX or QFracture (and measure BMD if required) according to local or national guidelines
      • more frequent reviews may be required if patient is prone to falling or re-fractures
      • practice-based pharmacists may undertake annual reviews as part of a medicines optimisation review and repeat prescribing; liaison with community pharmacists will enhance patient care.

Duration of therapy

  • Sequence of therapy post bone-forming agents
    • after teriparatide and biosimilars of teriparatide treatment course of 24 months switch patients to antiresorptive therapy
    • after romosozumab treatment course of 12 months switch patients to antiresorptive therapy
  • For denosumab the potential benefit-risk balance of treatment cessation is altered, and treatment switching should only be undertaken in consultation with a bone specialist; for other antiresorptive therapies, duration of therapy should be as per local or national guidelines with review of the risks versus benefits of discontinuing therapy
    • SIGN recommends that in post-menopausal women, the following therapies can be continued for:
      • 10 years—alendronic acid, strontium ranelate (if severe osteoporosis and other treatments are unsuitable), and denosumab
      • 7 years—risendronic acid 
      • 3 years—zolendronic acid.

Useful resources

NOGG=National Osteoporosis Guideline Group; ROS=Royal Osteoporosis Society

 

Guidance during the COVID-19 pandemic

BMD=bone mineral density; DXA=dual-energy X-ray absorptiometry; IOF=International Osteoporosis Foundation; ROS=Royal Osteoporosis Society

 

about this working party guideline …

sponsor—

Guidelines identified a need for clinical guidance in a specific area and approached UCB Pharma Ltd for an educational grant to support the development of a working party guideline. This working party guideline was developed by Guidelines, and the Chairs and members of the group were chosen by and convened by Guidelines. The content is independent of and not influenced by UCB Pharma Ltd, who checked the final document for technical accuracy and to ensure compliance with regulations. The views and opinions of the contributors are not necessarily those of UCB Pharma Ltd, or of Guidelines, its publisher, advisers, or advertisers. No part of this publication may be reproduced in any form without the permission of the publisher.

group members

Cyrus Cooper (Chair, Professor of Rheumatology), Kassim Javaid (Chair, Associate Professor in Metabolic Bone Disease), Mary Elliott (Fracture Liaison Service Clinical Nurse Specialist), David Stephens (GP), Nuttan Tanna (Pharmacist Consultant, Women’s Health & Osteoporosis/Bone Health)

further information

call MGP Ltd (01442 876100) for further information and a copy of the full guideline

Date of preparation: August 2020