Osteoporosis Clinical Guideline Rheumatology January 2017
Introduction Osteoporosis is a condition of low bone mass leading to an increased risk of low trauma fractures. The prevalence of osteoporosis is increasing rapidly with 1 in 2 women and 1 in 5 men over the age of 50 at risk of developing an osteoporotic fracture. The aim of assessment and treatment is to reduce future fracture risk. 2 Osteoporosis Clinical Guideline
Who to assess All patients over the age of 50 years with a low impact fracture should be offered a bone density scan. Fractures of the face and all small bones in the hand and feet are excluded. Other groups with one or more significant risk factor should be referred for a DEXA if their FRAX or Q-fracture assessment suggests a 10% risk of fracture within 10 years. https://www.shef.ac.uk/frax/tool.jsp or http://www.qfracture.org/3 Risk Factors It should be noted that the risk factors below only apply to patients >50 years apart from corticosteroid use and depot progesterone contraceptive use. Non modifiable v Parental history v Menopause <45years v Fragility fracture Modifiable v Smoking v BMI<20 v Alcohol >3.5 units/day Co-existing Disease v Asthma/COPD v Inflammatory joint disease v Inflammatory bowel disease/ malabsorption v Chronic liver disease v Chronic kidney disease v Chronic neurological disease (dementia, Parkinson s Disease, MS, stroke and epilepsy) v Diabetes v Endocrine disease Drug Therapy v Long-term antidepressants v Glucocorticoids v Anticonvulsants v Aromatase inhibitors v Depot progesterone contraceptive v GnRH agonists for prostate cancer v Glitazones Osteoporosis Clinical Guideline 3
Drug Treatment Please see attached flow-chart Prior to commencing therapy baseline blood investigations as a minimum should include full blood count, renal function, LFTs, calcium and Vitamin D (if Calcium/Vitamin D replacement is not being coprescribed). DRUG NOTES Oral Bisphosphonates Oral alendronate 70mg/week is the first line formulary choice. Risedronate is an option for patients who suffer minor GI intolerance with alendronate. Risedronate can be used down to an egfr of 30mls/min compared to 35 mls/min for alendronate. Although only the 10mg daily preparation of alendronate is licensed for osteoporosis treatment in men it is standard practise to use alendronate 70mg weekly. Other Options Parenteral therapies such as iv zoledronate and s/c denosumab are available for patients intolerant or unable to comply with the dosing regime for oral bisphophonates and are available through the Osteoporosis Clinic. Other options such as strontium ranelate or raloxifene can be considered for specific patients and generally this would be arranged through the Osteoporosis Clinic. Duration of Bisphosphonate Therapy For patients at high risk of a fragility fracture (>75yrs, previous hip or vertebral fracture or longterm steroids) then treatment should be for 10 years. For lower risk patients then treatment should be re-assessed at 5 years. This could include a repeat DEXA, if the risk of fracture remains high and/or DEXA t-score <-2.5 then a total of 10 years of treatment should be considered. There is no evidence of treatment benefit beyond 10 years. Alendronate remains in the skeleton for 2-3yrs after therapy is discontinued and risedronate about 18 months. If there is concern regarding ongoing fracture risk then repeating a DEXA 2 years after discontinuation is an option and offering a further 5 years therapy if there is a significant decline in the femoral neck t-score. Zoledronic acid persists in the skeleton for much longer and 3 years treatment is recommended with no re-treatment for at least a further 3 years. 4 Osteoporosis Clinical Guideline
Osteonecrosis of the Jaw and Atypical Femoral Fractures These serious conditions remain very rare and are markedly less frequent than a fragility fracture in a patient at risk. The estimate for osteonecrosis is 1 in 1000 patient/years and can be reduced by maintaining good dental health. From a large Swedish study the estimated risk for atypical femoral fractures is 1 in 2000 patient/years. Calcium and Vitamin D Most drug studies have included treatment with calcium and vitamin D. If a patient is assessed to have an adequate calcium intake (this can be calculated with an online calcium calculator*) then it would be worth checking their vitamin D status to see whether they need supplementation. For very low vitamin D levels (<25mmol) then treat with oral replacement of 50000iu weekly for 6-8 weeks followed by maintenance of 800iu daily. At levels of 25-50mmol then maintenance therapy of 800iu daily should be sufficient. Refer to formulary for up to date drug choices: http://www.medednhsl.com/meded/nhsl_formulary/index.asp?t=09&s=9.06 Monitoring Response by DEXA Repeat DEXA scanning is not routinely recommended unless the result is likely to alter treatment. An example of this would be for patients suffering a low trauma fracture whilst fully compliant with their treatment for more than 1 year. In other cases SIGN 142 recommends at least 3 years between scans. Please see note above regarding re-assessment of treatment. * http://www.cgem.ed.ac.uk/research/rheumatological/calcium-calculator Osteoporosis Clinical Guideline 5
Pathway for Secondary Prevention (adapted from SIGN 142) Fragility fracture age >50 DEXA T-score at spine or hip 2.5% NO Correct risk factors (The requirement and interval for repeat DXA should be decided on a case-by-case basis) YES Assess whether Calcium/Vitamin D supplementation is required (see notes above) Alendronic Acid or Risedronate (Continue medication for up to 10 years) Is unable to tolerate or treatments are contraindicated Refer to Osteoporosis Service 6 Osteoporosis Clinical Guideline
Pathway from risk factors to pharmacological treatment for Primary Prevention (adapted from SIGN 142) Clinical risk factors aged >50 Very strong clinical risk factors aged <50 Fracture Risk Assessment (FRAX or Q-Fracture) 10-year risk > 10% DEXA T-score at spine or hip 2.5% NO Correct risk factors (The requirement and interval for repeat DXA should be decided on a case-by-case basis) Assess whether Calcium/Vitamin D supplementation is required (see notes above) YES Alendronic Acid or Risedronate (Continue medication for up to 10 years) If unable to tolerate or treatments are contraindicated Refer to Osteoporosis Service Osteoporosis Clinical Guideline 7
Management of glucocorticoid induced fracture risk Oral glucocorticoid increase the risk of fragility fractures at higher BMD t-scores than usual. The treatment threshold is therefore lower. Oral glucocorticoid >3 months <65 years >65 years Measure BMD Previous fragility fracture >0 0 to -1.5 < -1.5 Assess and advise standard therapy with weekly Bisphosphonate +/- Calcium/Vit D supplements General measures General measures and consider repeating BMD after 2-3 years Pub. date: Apr 2017 Review date: Jan 2020 Issue No: 04 Department: Rheumatology MLT.OSTCLG.17_00960.L Design - Medical Illustration, NHS Lanarkshire