Dumfries and Galloway Treatment Protocol for Osteoporosis DIAGNOSIS OF OSTEOPOROSIS 2 Diagnostic Criteria 2 Multiple low trauma vertebral fractures in the absence of myeloma or metastatic disease. 2 T-score at hip or lumbar spine < -2.5. 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 SPECIAL CIRCUMSTANCES 8 Men Early Menopause or Menopausal Symptoms 9 9 Corticosteroid Induced Osteoporosis 9 Aromatase Inhibitors for Breast Cancer 9 MANAGEMENT OF OSTEOPOROSIS IN MEN & WOMEN 10 MANAGEMENT OF OSTEOPENIA IN MEN & WOMEN 11 CONTACTS 12 REFERRAL CRITERIA FOR OSTEOPOROSIS CLINIC 12 USEFUL WEB-SITES 12
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. NB Only refer for DEXA if result will affect management. Dexa is not required to confirm diagnosis in all cases -see diagnostic criteria. 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 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 Alendronate 70mg per week or 10 mg per day. Risedronate 35mg per week or 5mg per day. Risedronate Combi 35mg per week plus daily ca & vit D Ibandronate 150mg monthly. Didronel PMO Intravenous Ibandronate 3mg bolus every 3 months. Intravenous Zolendronate 5mg infusion once a year. 5
Treatment Strontium Ranelate Patient group Women age 80 years or above with 2 or more vertebral fractures 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. 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 where bisphosphonates haven t worked (which means that after 1 year of treatment with a bisphosphonate, another fracture has occurred and bone density has decreased to a level lower than when treatment started) or for women who are unable to take bisphosphonates because of the side effects and have a very high risk of fracture, as indicated by: T-score of 4 SD or below or T-score of 3 SD or below and more than two fractures and at least one of the additional risk factors listed above for bisphosphonates, except for women who have a medical condition that is independently associated with bone loss. Daily subcutaneous injection for 18 months. Hospital Prescription only refer to Dr Anne Drever, Osteoporosis clinic, DGRI. 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 Natecal D3 2 tabs per day. Adcal D3 2 tabs per day. Calfovit D3 1 sachet nocte. (1 tablet may be acceptable in younger individuals whose diet is inadequate). * 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 calcium supplements are only used in younger patients 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
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 - Alendronate 70mg per week or 10 mg per day. Risedronate 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 Corticosteroid Induced Osteoporosis Treat prophylactically if >65years, previous low trauma fracture or t-score <-1.5. (See RCP guidelines). Preparations available Alendronate 70mg per week. Risedronate 35mg per week. Didronel PMO. Aromatase Inhibitors for Breast Cancer See additional guideline. 9
Management of Osteoporosis in Men & Women (T Score < -2.5) 50 65 years old >65 years old Previous low trauma fracture or vertebral fractures seen on morphometry* yes Treatment 1 st line - bisphosphonate no Non drug treatment for all. Drug treatment not required unless very low BMD (<-4.5) or multiple risk factors as 10 year fracture risk low. Repeat DEXA at 2 years if not on treatment or start treatment at age 65 years *Morphometry a low radiation method of visualising the spine whilst carrying out DEXA. Useful for detecting vertebral abnormalities such as asymptomatic compression fractures. Currently unable to offer this facility on all scans in view of the increase in scanning time required however DEXA referral cards will be triaged by the radiology department with those stating height loss or kyphosis being allocated longer scanning appointments for morphometry. 10
Management of 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 11
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 12