Bone Health Pathway Management Of Patients With .

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Bone Health PathwayManagement of Patients with Osteoporosis or at Risk of OsteoporosisGuidelines for Primary CareTitle of guidelineOriginal version producedUpdatedReview dateDeveloped and written byReviewed and updated byContributorsBone Health PathwayManagement of Patients with Osteoporosis or at Risk of OsteoporosisGuidelines for Primary CareMay 2013May 2020May 2023 (or earlier if indicated)Mohammed Swaleh - Integrated Falls and Bone Health Pharmacist, St. George’s University HospitalDr Katie Moss - Consultant Rheumatologist and Osteoporosis/Metabolic Bone Disease Specialist, St. George’s University HospitalDr Arvind Kaul - Rheumatology Care Group Lead, Consultant Rheumatologist, St. George’s University HospitalDr Helena Robinson - Consultant in Rheumatology, St. George’s University HospitalWei Zhang - Fracture Liaison Nurse, St. George’s University HospitalMauricia Regis - Dexa Technician, St. George’s University HospitalSouth West London CCG Medicine Optimization TeamThis guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient. If patientsfall outside the scope of this guideline, seek specialist advice or consider a referral to secondary care. The Integrated Falls and Bone Health Service or Fracture Liaison Nurse mayprovide further advice.

CONTENT1 Osteoporosis treatment pathways1.1 Primary prevention/no previous fragility fracture1.2 Possible vertebral fracture?1.3 Secondary prevention/previous fragility fracturePAGE12 What is osteoporosis; which target groups we need to assess and how?2.1 Osteoporosis2.2 Consider fracture risk assessment for the following patient groups?2.3 FRAX - fracture risk assessment tool for use in treatment-naïve patients23 Essential bone health supplementation and physiotherapist falls risk assessment3.1 Calcium supplementation3.2 Physiotherapist falls risk assessment3.3 Vitamin D supplementation34 High risk groups for osteoporosis and HRT45 Useful information when conducting a bone health reviewReview period and “drug holiday” recommendations for bisphosphonatesBase line tests and additional test investigationsFracture prevention efficacy tableTop tips for GP practicesIndications for referral to the Osteoporosis Clinic, St Georges Hospital54.1 Glucocorticoid-induced osteoporosis4.2 Patients taking an aromatase inhibitor or a gonadotropin‐releasing hormone (GnRH) analogue4.3 Hormone replacement therapy (HRT) for osteoporosis5.15.25.35.45.56 Treatment options6.1 First line bisphosphonates6.2 Other treatments6.3 Hospital only667References8Appendix 1: Risk factor for osteoporosisAppendix 2: Symptoms suggestive of vitamin D deficiencyAppendix 3: Risk Groups for Vitamin D DeficiencyAppendix 4: CKD: NICE Clinical guideline [CG182]Appendix 5: Bisphosphonate counselling advice checklist999910

Page 1 – Osteoporosis treatment pathways for adults1. Primary prevention/no previous fragility fractureGlucocorticoid exposure 3 months ( 7.5 mg/day prednisolone or equivalent)NOYESConsider Fracture Risk Assessment for groups;24 Women 65yrs and men 75yrs or Women and men 50yrs with 1 RISK FACTORS34Low dose 7.5mg/dayHigh dose 7.5mg/dayRISK FACTORS34 – APPENDIX 12. Possiblevertebralfracture?(Indicated byback pain, heightloss or kyphosis)Lateral thoracic &lumbarspine X raysVertebral fracturepresent?3. Secondary prevention/previous fragilityfractureIf patient has beenassessed by FractureLiaison Service (FLS)If no previous assessment with theFracture Liaison Service (FLS)Follow advice andrecommendations(Refer to EPR/iCLIP)Age 50-70yrsAge 70yrsCalculate 10-year fracture risk using FRAX tool(Validated for 40-90yrs only)Intermediate RiskLow RiskAge 75yrsNOInvestigationsFollow KyphoplastypathwayEmail Fracture LiaisonService (FLS)fls@stgeorges.nhs.ukHigh RiskAge 75yrsMeasure BMD (DXA scan hip spine)and recalculate FRAX Report sent to referring clinician (plus GP)NODoes patient have 2Significant Risk Factorand/or an Indicatorof Low BMD listed inTable 1?If no sign of vertebralfracture then followprimary prevention/noprevious fragilityfracture pathwayYESBelow NOGGtreatmentthresholdAbove NOGGtreatmentthreshold Measure BMD (DXA scan hip spine) and recalculate FRAX Report sent to referring clinician (plus GP)Reassesspatient afterminimum of2 years or ifclinicalconditionBelow NOGGtreatmentthresholdAbove NOGGtreatmentthresholdInvestigationsTreat (seepage 6)General Measures; Exercise classes, falls risk assessment, calcium supplementation and vitamin D supplementationTable 1Significant Risk Factor Rheumatoid arthritis Parental history hip fracture Alcohol intake ( 4units/day) GlucocorticoidIndicators of Low BMD Untreated prematuremenopause BMI 19kg/m2 Ankylosing spondylitis Crohn’s disease Prolonged immobilisationReassess patientafter minimumof 2 years or ifclinical conditionchangesInvestigationsTreat (seepage 6)General Measures; Exercise classes, falls risk assessment, calciumsupplementation and vitamin D supplementation

Page 2 – What is osteoporosis; which target groups do we need to assess and how?4. OsteoporosisDefinition Osteoporosis is a complex skeletal disease characterised by low bone density and micro-architecturaldefects in bone tissue, resulting in increased bone fragility and susceptibility to fracture. Osteoporosis isdefined as a value for bone mineral density T score of -2.5 SD or more below a young female adult mean.1Diagnosis The diagnosis of osteoporosis is a quantitative assessment of bone mineral density (BMD) by axial dualenergy X-ray absorptiometry (DXA). BMD at the femoral neck provides the reference site and is reported asa T-score.T-scoreResults compared to an healthy female adult aged 30 years-1.0 or aboveNormal BMD-1.0 and -2.5Osteopenia-2.5 and lowerOsteoporosisZ-scoreResults compared to a person of same gender and age-2.0 to 0 (or higher)Within expected range for age-2.0 to -3.0 (or lower)Outside expected range for age Osteoporosis may be assumed in women aged 75 years or older who have sustained fragility fracture if aDXA scan is considered to be clinically inappropriate or unfeasible.6. FRAX - fracture risk assessment tool for use in treatment-naïve patientsFRAX2 is validated to be used in untreated patients only (e.g. treatment-naïve patients) except in cases when it is beingused to assess continuation of bisphosphonate treatment.FRAX is the preferred fracture risk assessment tool for Wandsworth and calculates the 10-year probability of a majorosteoporotic fracture and a hip fracture.FRAX Fracture Risk Assessment ToolLinkAge RangeOutside Age RangeHigh RiskIntermediate RiskLow RiskLimitations3Underestimationof fracture risk Medication(s) that may impair bone metabolism;- Aromatase inhibitors e.g. anastrozole, exemestane, letrozole- Anti-androgen therapy e.g. leuprorelin acetate, goserelin- Hyperthyroidism (other term thyrotoxicosis or excess thyroxine)- Antidepressants (particularly SSRIs)- Long-term heparin- TZDs (e.g. Glitazones)- Anti-epileptic medications- High dose PPI’s ( 1yrs)- Long term Depo-Provera ( 2yrs)Fragility fractures Fragility fractures are defined as a fractures caused by falling from standing height or lower at walkingspeed or slower i.e. mechanical forces that would not ordinarily result in a fracture. They also includevertebral and hip fractures even if there is no history of trauma. Fractures of the skull, facial bones, or digits are not included. The terms low trauma fracture andosteoporotic fracture have an identical meaning for the purpose of this guidance. Secondary causes of osteoporosis;- Gastrointestinal e.g. coeliac disease, inflammatory bowel disease, chronic liver disease- Endocrine e.g. diabetes, hyperthyroidism, hyperparathyroidism, Cushing’s disease,hypogonadism in either sex including untreated premature menopause- Rheumatological e.g. rheumatoid arthritis, other inflammatory arthopathies- Respiratory disease e.g. asthma and COPD- Metabolic e.g. homocystinuria- Other e.g. chronic renal disease, immobility, treatment of HIV, immobility,24Patients 50 yearsPatients 50 years who have a major risk factor (see below) then complete next step below:Major Risk Factors Current/frequent use oral or systemic glucocorticoids ( 7.5mg prednisolone or equivalent for 3 months) Untreated premature menopause History multiple fragility fracture or osteoporotic fractureNext StepPatients 40 years Complete a DXA scan (measure BMD) and basicinvestigations for patients (refer to table) GP to refer patient to Osteoporosis Clinic, SGHwith completed DXA scan basic investigation resultsPatients over 50 years who have 1 risk factor (appendix 2) then follow either the primary/secondary orpossible vertebral fracture osteoporosis treatment pathway for adults – page 1Women 65 years and men 75 years Patients 40-50 years Calculate FRAX score (FRAX online tool) andfollow recommendationsPatients 50 yearsWomen and men in the following age groups then follow either the primary/secondary or possiblevertebral fracture osteoporosis treatment pathway for adults – page 1a) Patients taking high dose glucocorticoidFRAX may underestimate fracture probability in patients taking a high-dose systemicglucocorticoids [ 7.5mg/day prednisolone or equivalent for 3months]b) Patients that have risk factors not included in the FRAX The Z-score is a useful indicator of possible secondary osteoporosis as it can help identify if there are anyunderlying metabolic disorders contributing to osteoporosis. If age-match Z score -2.0, then referral toosteoporosis clinic may be appropriate for more thorough investigation.5. Consider fracture risk assessment for the following patient groups?www.shef.ac.uk/FRAX/tool.jsp40-90 yearsUse clinical judgement or seek advice to access fracture riskRed zone of risk chartYellow zone of risk chartGreen zone of risk chartThoracic kyphosis and height loss ( 4cm)History of multiple fracturesPrevious vertebral fracture(s)High alcohol intakeLiving in a care homeNutritional deficienciesRecurrent fallsIf 80 years - interpret score with caution - NICE CG1464Clinical judgment when using FRAX score FRAX may underestimate fracture probability (refer to above table) therefore; clinical judgment should be used tointerpret the results together with FRAX score. If a patient has been identified to have risk factors not included in the FRAX assessment tool, but who are below butclose to the treatment threshold line, treatment should be considered Use the BMD (g/cm2) value at femoral neck when recalculating FRAX (e.g. to determine treat or no treat)QFracture QFracture5 (30-99yrs) is an alternative fracture risk online assessment tool. This tool estimates the 1-10 year cumulativeincidence of hip or major osteoporotic fracture. QFracture doesn’t incorporate DEXA results, has no thresholds and notreatment levels.

Page 3 – Essential bone health supplementation and physiotherapist falls risk assessment9. Vitamin D supplementation127. Calcium supplementation Patients to be prescribed recommended dose calcium 1 – 1.2 gram colecalciferol20 micrograms (800units) daily unless clinician is confident that dietary calciumintake is adequate and patient is vitamin D replete. Frail elderly patients (over 65yrs) that are housebound or living inresidential/nursing homes are likely to gain benefit from lifelong calcium vitaminD supplementation. You may refer to dietary calcium calculator7 and NOS leaflet.8Serum 25-(OH) D level(Vitamin D status)Treatment doseFrequencyMonitoring Requirements 30nmol/L - DeficientPlenachol 20,000units or 40,000unit capsStexerol 25,000units tabs40,000units every week for 7 weeks50,000units every week for 6 weeksIf unable to swallow tabs/caps:Invita D3 50,000units oral solutionThorens 25,000units/2.5mL oral solutionRoutine follow-up serum 25(OH) D not indicated unlesspatient;50,000units weekly for 6-8 weeks50,000units weekly for 6-8 weeksIf daily dosing preferred (but more costly):Fultium D3 3,200unit caps:Stexerol 1,000units tabs:3,200units daily for 12 weeks3,000-4000units daily for 10-12 weeks has malabsorption/GIproblems orNote:Treatment dose to be prescribed followed by OTCor prescribed maintenance dose* as per theSW London CCGs Vitamin D position statementNote:Treatment dose to be prescribed followed by OTCor prescribed maintenance dose* as per theSW London CCGs Vitamin D position statement is at high risk or has had aprevious fracture Refer to “Optimise Rx” recommendations – preferred choices below. BNF 749BrandAdcal-D3Adcal-D3Adcal-D3AccreteCalfovit D3Calci-DFormulationChewable tabsCapletsEffervescent tabsTabSachetChewable tabsStrength1.5g 400units750mg 200units1.5g 400units1.5g 400units1.2g 800units1g 1,000unitsCalcium content600mg300mg600mg600mg1200mg1000mgDose1 BD2 BD1 BD1 BD1 OD1 OD Calcium salts reduce absorption of bisphosphonates, oral iron salts andlevothyroxine30-50nmol/L - Insufficient Fragility fracture, documentedosteoporosis/osteomalacia or high fracture risk Treatment with antiresorptive medication forbone disease Symptoms suggestive of vitamin D deficiency(Appendix 2) Increased risk of developing vitamin D deficiencyin the future because of reduced sunlightexposure, cultural dress code, dark skin etc.(see “groups at risk of vitamin D deficiency” Appendix 3) Raised PTH Medication with antiepileptic drugs or oralglucocorticoids Conditions associated with malabsorption Do not take calcium supplement within 4 hours of bisphosphonate.10 Patient canopt to miss out calcium and vitamin D supplementation dose for that day until thefollowing day so that the supplement does not interfere with the absorption of thebisphosphonateCardiovascular Risk MHRA recommends no changes to the prescribing of calcium and vitamin Dsupplements despite concerns about increased cardiovascular risk in a recent metaanalysis.118. Physiotherapist falls risk assessmentThe Integrated Falls and Bone Health Service will carry out a Falls Risk Assessment andprovide the following advice; Nutrition advice for good bone healthTailored individualised weight-bearing exercisesThe importance of maintaining healthy body weight (aim for BMI 20-25kg/m2)Importance of stopping smoking and reducing alcohol intake ( 2 units/day)Sun and vitamin D advice6 - must be balanced against skin cancer risk from sunexposureExercise classes and educational talks Patients can be referred to the Integrated Falls and Bone Health Service based at StJohns Hill Therapy Centre, Battersea for various levels of Bone Boost Classes(beginner level to advanced level), Nordic walking sessions and our Healthy BonesEducational sessions. Muscle strengthening and balance training exercise interventions will help reducefalls by improving confidence and coordination as well as maintaining bone mass.Prescribe and treat as for deficiency IF symptomaticAND/OR one of the following risk factors present.Adjusted serum calciumshould be checked 1 monthafter (if indicated) completingthe high dose vitamin D orafter starting maintenancevitamin D supplementation, incase primaryhyperparathyroidism hasbeen unmasked or to detecthypercalcaemia.If a follow-up 25-(OH)Dmeasurement is required; itshould be madeapproximately six monthsafter initiating maintenancetherapy to confirm that thetarget level has beenachieved. 50nmol/L - SufficientAdvise purchasing a vitamin D maintenance dose*OTC supplement PLUS reassurance and diet/lifestyle advice alone.*Maintenance doseMaintenance dose regimens may be considered 1 month after loading. Maintenance dose to beprescribed only where clinical assessment of the patient indicates that continuous treatment isjustified e.g. conditions resulting in intestinal malabsorption, bone health issues etc.Serum 25-(OH) levels recommended to be reviewed after 6 months.Stexerol 1,000units tabletsPlenachol 20,000units or 40,000units capsulesStexerol 25,000units tabletsInvita D3 25,000units oral solutionThorens 25,000units/2.5mL oral solutionThorens 10,000units/mL oral drops vitamin D deficiencysymptoms continue orTo provide 800-2000units dailySome patients may require asecond treatment dose toreach target levels or referralto secondary care.1,000units daily20,000-40,000units once a month25,000units-50,000units once a month25,000units once a month25,000units to 50,000units once a month800units (4 drops) dailyPatients with established bone disease e.g. previous osteoporotic fractures should maintain a vitamin D level 75nmol/LRefer to Vitamin D Deficiency: Prevention and Treatment for Adults in Primary Care, 201612 for more detailed informationPatients groups contraindicated to vitamin D supplementationAvoid in patients with severe renal impairment (CKD stage 4 or eGFR 30ml/min/1.7), patients with hypercalcaemia or metastatic calcification,primary hyperparathyroidism, renal stones, severe hypercalciuria and nephrocalcinosis.

Page 4 – High risk groups for osteoporosis and HRTIncreased fracture risk when taking glucocorticoid11. Patients taking an aromatase inhibitor or a gonadotropin‐releasing hormone(GnRH) analogue Glucocorticoid therapy is associated with bone loss and increased risk of fractures. The greatest rate of boneloss occurs early after initiation of glucocorticoids and increases with dose and duration of therapy.19Patients on breast or prostate cancer treatment should be investigated and managed according to their relevant specialtyguidelines. Refer to bone protection treatment assessment in yellow (see below).10. Glucocorticoid-induced osteoporosis Patient’s 70 years taking high doses of glucocorticoids ( 7.5 mg/day prednisolone for 3 months), exceed theintervention threshold and should be considered for bone protective therapy.3 Treatment should be started at the onset of glucocorticoid therapy without the need for a DXA scan.FRAX adjustments – when taking glucocorticoid3NICE guidanceDrugsWhen the UK FRAX model is used and the glucocorticoid box is filled, 2 points appear on the NOGG graphs, onefor 2.5-7.5mg daily of prednisolone or its equivalent (x), and one for 7.5mg daily of prednisolone(x). Refer toGraph 1. Repeat BMD every 2 – 3 years and review osteoporosis management if glucocorticoids are continued.Graph 1Adjustment of FRAX estimates of fracture probability according to dose of prednisolone (Kanis et al 2011)3DosePrednisoloneAverage adjustment:Average adjustment:equivalent mg/dayHip fracture probabilityMajor osteoporotic fracture probabilityLowMediumHigh 2.52.5 – 7.5 7.5-35%None 20%-20%None 15%Aromatase inhibitors NICE CG10120 - Breast cancer Anastrozole (Arimidex) Exemestane (Aromasin) Letrozole (Femara)Note: Tamoxifen is not an aromataseinhibitorGnRH analogues NICE CG13121 - Prostate cancer Leuprorelin acetate (Prostap 3) Goserelin (Zoladex)Androgen deprivation therapy (ADT) usinggonadotropin-releasing hormone (GnRH)agonist or GnRH antagonist therapyFracture risk Aromatase inhibitors reduce oestrogenlevels which increase the rate of boneturnover and can cause significant andvery rapid bone density loss of up to 8%per year in younger women.8 The use of GnRH analogues in men isassociated with bone loss and fracturesBMD(by axial DXA) Measure baseline BMD within 6 monthsof starting treatment Repeat axial DXA after 24 months. Measure BMD if FRAX score indicatedBone protectiontreatment assessmentBone protection treatment should beoffered to patients identified by algorithms1 and 2 in ‘Guidance for the managementof breast cancer treatment-induced boneloss: a consensus position statement froma UK expert group’ (2008)35 Bone protection should not be routinelyoffered to patients on androgendeprivation therapy (ADT). Patients shouldbe risk assessed as normal and offeredtreatment if the risk assessment (FRAXand/or DXA scan) shows it is indicated. Offer bisphosphonates to patients who arehaving androgen deprivation therapy andhave osteoporosis. Should be consider for denosumab ifbisphos

Bone Health Pathway . Management of Patients with Osteoporosis or at Risk of Osteoporosis . Guidelines for Primary Care . Title of guideline Bone Health Pathway Management of Patients with Osteoporosis or at Risk of Osteoporosis Guidelines for Primary Care Original version produced May

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