Dumfries and Galloway Treatment Protocol for Osteoporosis DIAGNOSIS OF OSTEOPOROSIS 2 Diagnostic Criteria 2 REFERRAL CRITERIA FOR DEXA 3 TREATMENT 4 Non-Drug Therapy : for all 4 Non-Drug Therapy : in the elderly 4 Bone Forming Agents 7 Additional Supplements 8 NICE GUIDANCE FOR POSTMENOPAUSAL OSTEOPOROSIS 9 NICE GUIDANCE FOR ALENDRONATE INTOLERANCE 10 CONCISE GUIDE - OSTEOPOROSIS IN MEN & WOMEN 12 CONCISE GUIDE - OSTEOPENIA IN MEN & WOMEN 13 SPECIAL CIRCUMSTANCES 14 CONTACTS 16 REFERRAL CRITERIA FOR OSTEOPOROSIS CLINIC 16 USEFUL WEB-SITES 16
Diagnosis of Osteoporosis Diagnostic Criteria Multiple low trauma vertebral fractures in the absence of myeloma or metastatic disease. Or T-score at hip or lumbar spine < -2.5. NB Treatment can be commenced without DEXA confirmation of osteoporosis if - Multiple low trauma vertebral fractures in the absence of myeloma or metastatic disease. - Women >75 yrs with 2 or more low trauma fractures. Exclude secondary causes in all cases with metabolic screen and clinical examination. (FBC, ESR, U&E, LFT, Ca, vit D, CRP, TFT, PEP, urine BJP, testosterone in men <60) 2
Referral Criteria for DEXA Low Trauma Fracture in past 5 years. On oral corticosteroids (any Dose) for more than 3 months and less than 65 years old with no previous low trauma fracture. Radiological vertebral osteopenia. Secondary Cause of osteoporosis. Postmenopausal women age 50yrs or above with - Untreated (i.e. unable to take HRT) natural or surgical menopause before age 45. or 2 or more of the following risk factors - Premenopausal amenorrhea > 6 months. - Smoke > 5 cigarettes per day. - BMI < 19. - Maternal, paternal or sister history of osteoporosis (diagnosed by doctor) or hip fracture < 80 years old. - Regular excessive alcohol intake (4 or more units / day.) NB Only refer for DEXA if result will affect management. Dexa is not required to confirm diagnosis in all cases see page 2. Depo-Provera decision to use or continue this form of contraception for >2yrs should be based on presence of risk factors (as above) rather than BMD level. DEXA only required if fulfils above referral criteria. -see NOS advice leaflet www.nos.org.uk DEXA not possible at DGRI for those < age 21. 3
Treatment Non-Drug Therapy: for all Adequate daily intake of calcium and vitamin D. Regular weight bearing exercise. Stop smoking. Reduce alcohol intake. Non-Drug Therapy: in the elderly All of the above plus Falls risk reduction e.g. - Sensory loss (vision, hearing, peripheral neuropathy). - Drug related (sedatives, postural hypotension, arrhythmias). - Locomotor disorders. Consider hip protectors (evidence of benefit only in those in nursing care and protectors worn 24 hrs a day) not available on NHS. Refer to falls clinic if recurrent unexplained falls. 4
Treatment Bisphosphonates Patient group see algorithm - Consider generic Alendronate as first line in all patients. - Optimal choice of agent is dependent on individual patient benefits - Alendronate binds more potently to bone and has greater effect on BMD. - Risedronate has more efficacy and safety data in the very elderly. - Some evidence of less GI irritation with Risedronate Both are well tolerated if comply appropriately with method of administration (on first rising in morning with glass of water, moving around and nil else by mouth for at least 30 minutes). Evidence of vertebral and peripheral fracture reduction. Monthly Ibandronate appropriate if polypharmacy or intolerance of Alendronate and Risedronate. Intravenous Ibandronate by a 3 monthly bolus is the intravenous preparation of choice for those unable to take oral preparations or with malabsorption. Preparations available Alendronic Acid 70mg per week. Risedronate Sodium 35mg per week. Ibandronic Acid 150mg monthly. Didronel PMO Intravenous Ibandronic Acid 3mg bolus every 3 months. Intravenous Zoledronic Acid 5mg infusion once a year. 5
Treatment Strontium Ranelate Patient group Women age 80 years or above with 2 or more prior fractures (peripheral or vertebral) or peripheral fracture and t-score <- 2.5 as first line option. Also, women age 75 80 years with established osteoporosis and intolerant of oral bisphosphonate. Daily suspension taken last thing at night. Less risk of upper GI intolerance main side effect diarrhoea. Tolerated better in frail elderly if introduced initially as half a sachet per day. Small increased risk of thrombosis. Future Dexa measurements are impaired therefore avoid in use in younger patients if possible. Preparation available Strontium Ranelate 2gm nocte (for women age 80 or above). Strontium Ranelate 2gm nocte (for women 75-80 years). Raloxifene Patient group - younger ladies, intolerant of bisphosphonates, at least 1 year post menopausal at significant risk of vertebral fracture and breast cancer for secondary prevention of fracture (NICE do not recommend use of Raloxifene for primary prevention). No evidence of peripheral fracture reduction. Increased risk of thrombosis as for HRT. Preparation available Raloxifene 60 mg per day 6
Treatment Bone Forming Agents Teriparatide Patient group women aged 65 and older for secondary prevention of osteoporotic fracture if unsatisfactory response to bisphosphonates (a further low trauma fracture has occurred after at least one year of treatment) or unable to take bisphosphonates or Strontium Ranelate because of side effects or contraindication and have a very high risk of fracture, as indicated by: T-score of 4 SD or below or T-score of 3.5 SD or below and at least 2 low trauma fractures with multiple risk factors or T-score of -4 or below plus 2 or more fractures if age 55-64 years. Daily subcutaneous injection for 18-24 months. Hospital Prescription only. Refer to osteoporosis clinic for repeat DEXA to ascertain eligibility. Preparation available Teriparatide 20 micrograms per day subcutaneously. 7
Treatment Additional Supplements Calcium & Vitamin D Patient group All those >70 years old with osteoporosis as additional supplement to treatment. Those < 70 years old with osteoporosis and inadequate diet or confirmed deficiency. * Ambulatory frail elderly in residential or nursing care with additional risk factors for treatment and prevention. Recommended preparations Adcal D3 2 tabs per day. Calchichew D3 Forte 2 tabs per day. Calfovit D3 1 sachet nocte. (1 tablet may be acceptable in younger individuals whose diet is inadequate). Absorption is improved by splitting the dose rather than taking 2 tablets together. On day of oral bisphosphonate either omit calcium and vitamin D or take at lunch and evening meal. * There is recent evidence suggesting that excessive calcium intake may increase risk of cardiovascular disease. It has been known for some time that renal stone disease is increased. Therefore recommend that in younger patients supplements are only used if diet clearly insufficient or biochemical deficiency. Diet can be assessed by on-line questionnaire at - http://www.rheum.med.ed.ac.uk/resources/calcium/ 8
NICE Guidance for Prevention of Osteoporotic Fracture in Postmenopausal Women Primary Prevention (TA160) Alendronate is recommended as a treatment option for primary prevention of osteoporotic fragility fractures in the following groups: Women aged 70 years or older who have an independent clinical risk factor for fracture or an indicator of low BMD and who are confirmed to have osteoporosis (t-score -2.5 or below).in women aged 75 years or older who have 2 or more indicators for clinical risk factors for fracture or indicators of low BMD, a DEXA scan may not be required if the responsible clinician considers it to be clinically inappropriate or unfeasible. Women aged 65-69 years who have an independent clinical risk factor for fracture and who have confirmed osteoporosis (t-score - 2.5 or below). Postmenopausal women younger than 65 years who have an independent clinical risk factor for fracture and at least one additional indicator of low BMD and who are confirmed to have osteoporosis (t-score -2.5 or below). Secondary Prevention (TA161) Alendronate is recommended as a treatment option for secondary prevention of osteoporotic fragility fractures in postmenopausal women who are confirmed to have osteoporosis (t-score of -2.5 or below). In women age 75years or older, a DEXA scan may not be required if the responsible clinician considers it to be clinically inappropriate or unfeasible. 9
NICE Guidance for Patients Intolerant of Alendronate Primary Prevention of Osteoporotic Fracture T-scores (SD) at (or below) which risedronate or etidronate is recommended when alendronate cannot be taken Age (years) Number of independent clinical risk factors for fracture (see section 1.5) 0 1 2 65 69 a 3.5 3.0 70 74 3.5 3.0 2.5 75 or older 3.0 3.0 2.5 a Treatment with risedronate or etidronate is not recommended. T-scores (SD) at (or below) which strontium ranelate is recommended when alendronate and either risedronate or etidronate cannot be taken Age (years) Number of independent clinical risk factors for fracture (section 1.5) 0 1 2 65 69 a 4.5 4.0 70 74 4.5 4.0 3.5 75 or older 4.0 4.0 3.0 a Treatment with strontium ranelate is not recommended. Independent Clinical Risk Factors for Fracture Parental history of hip fracture alcohol intake of 4 or more units per day rheumatoid arthritis. Indicators of Low BMD BMI<22, medical conditions resulting in prolonged immobility untreated early menopause. NICE TA160 10
NICE Guidance for Patients Intolerant of Alendronate Secondary Prevention of Osteoporotic Fracture T-scores (SD) at (or below) which risedronate or etidronate is recommended when alendronate cannot be taken Number of independent clinical risk factors for fracture (section 1.5) Age (years) 0 1 2 50 54 a 3.0 2.5 55 59 3.0 3.0 2.5 60 64 3.0 3.0 2.5 65 69 3.0 2.5 2.5 70 or older 2.5 2.5 2.5 a Treatment with risedronate or etidronate is not recommended T-scores (SD) at (or below) which strontium ranelate or raloxifene is recommended when alendronate and either risedronate or etidronate cannot be taken Number of independent clinical risk factors for fracture (section 1.5) Age (years) 0 1 2 50 54 a 3.5 3.5 55 59 4.0 3.5 3.5 60 64 4.0 3.5 3.5 65 69 4.0 3.5 3.0 70 74 3.0 3.0 2.5 75 or older 3.0 2.5 2.5 a Treatment with raloxifene or strontium ranelate is not recommended NICE TA161 11
Concise Guide - Osteoporosis in Men & Women (T Score < -2.5) 50 65 years old >65 years old 80 years or above Previous low trauma fracture or vertebral fractures seen on morphometry* yes Treatment 1st line - bisphosphonate no Treat if an independent risk factor for fracture plus at least one additional indicator for low BMD (see page 10) or assess 10 year risk of major osteoporotic fracture on FRAX ** Bisphosphonate or Strontium Ranelate (in women) 1 st line dependant on patient characteristics Repeat DEXA at 2 years if not on treatment or start treatment at age 65 years *Morphometry (also known as Vertebral Fracture Assessment or VFA) a low radiation method of visualising the spine whilst carrying out DEXA. Useful for detecting vertebral abnormalities such as asymptomatic compression fractures. In view of the increase in scanning time required DEXA referrals are triaged by the radiology department with those stating height loss or kyphosis being allocated longer DEXA appointments for this. **FRAX - see on-line fracture risk calculator and treatment guidance charts at http://www.shef.ac.uk/frax/. 12
Concise Guide - Osteopenia in Men & Women (T Score -1 to -2.5) 50 65 years old Over 65 yrs old Known vertebral fractures or vertebral fractures seen on morphometry* Previous low trauma Fracture (peripheral or vertebral) no no yes Multiple vertebral fractures on morphometry or single vertebral plus previous peripheral fracture fractures no yes T score -1 to -2 T Score <-2 Treatment 1 st line - bisphosphonate Single vertebral fracture no peripheral fracture no yes Repeat dexa 5 years Repeat dexa 2 years 13
Special Circumstances Men 50% of men with osteoporosis have an underlying cause. Consider referral for specialist opinion if age < 60 years. Once weekly Alendronate is not licensed for this indication but is considered as gold standard treatment. Risedronate is licensed however has not been approved for use in men by the SMC. Preparations available - Alendronic Acid 70mg per week or 10 mg per day. Risedronate Sodium 35mg per week or 5mg per day. Early Menopause or Menopausal Symptoms Hormone Replacement Therapy Patient group - women with premature menopause up to age 50 for bone protection or those with troublesome menopausal symptoms. Those on HRT do not require additional drug treatment for osteoporosis for the duration of the HRT therapy. Benefit with regard to bone protection is lost after approx 2 years. Preparations available multiple Premenopausal Women Fragility fracture risk is very low in this group even if already sustained a fracture. There are also potential concerns about very longterm bisphosphonate use (>20 years). Risk of treatment may therefore be greater than benefit. DEXA is only recommended in premenopausal women if- Secondary cause of osteoporosis (including anorexia nervosa). Unexplained low trauma vertebral fracture. DEXA unhelpful in those < 21 in view of lack of reference ranges. 14
Special Circumstances Corticosteroid Induced Osteoporosis Treat prophylactically if >65years, previous low trauma fracture or t-score <-1.5. (See RCP guidelines) Vitamin D deficiency is higher in this group because of comorbidity therefore prescribe calcium and vitamin D supplements to all unless contraindication. Preparations available Alendronic Acid 70mg per week. Risedronate Sodium 35mg per week. Aromatase Inhibitors for Breast Cancer See additional guideline. Chronic Renal Disease Bisphosphonates and Strontium Ranelate undergo renal excretion and accumulation may occur in patients with impaired renal function. There is variation in the lower limit of CrCl quoted in the data sheets below which each drug is not recommended Alendronic Acid <35ml/min Ibandronic Acid and Risedronate <30ml/min Strontium Ranelate <30ml/min There is some evidence for the safety of oral bisphosphonates at usual doses down to GFR 15ml/min. Annual monitoring of creatinine is recommended in patients on bisphosphonates with CKD 4. HRT and Raloxifene can be used in patients with severe renal disease and on dialysis however benefits must be weighed against increased risk of thrombosis. Ensuring calcium & vitamin D replete is paramount in CKD. 15
Contacts Dr Anne Drever Monday 2-4pm Phone 241023 (Associate Specialist, Rheumatology) anne.drever@nhs.net Sr Katrina Martin Thursday 9-12pm Phone ex.32182 (Specialist nurse) katrina.martin@nhs.net Referral Criteria for Osteoporosis Clinic Established osteoporosis with further low trauma fracture despite appropriate treatment and compliance (where Teriparatide may be appropriate) Established osteoporosis with multiple drug intolerance or malabsorption (where intravenous preparations may be appropriate) Osteoporosis in men intolerant of oral bisphosphonate. Useful Web-sites National Osteoporosis Society Menopause Matters FRAX WHO Fracture Risk Calculator www.nos.org.uk www.menopausematters.co.uk http://www.shef.ac.uk/frax/ Colour Code First line treatment Second line treatment Prescribed via osteoporosis clinic 16