DERBYSHIRE JOINT AREA PRESCRIBING COMMITTEE (JAPC) OSTEOPOROSIS GUIDELINE

Transcription

1 DERBYSHIRE JOINT AREA PRESCRIBING COMMITTEE (JAPC) OSTEOPOROSIS GUIDELINE This is an updated guideline It incorporates the latest NICE guidance There are strong recommendations for calcium + vitamin D prescribing. Consider annual vitamin D injection (150, ,000 IU) if compliance is a problem Treatment algorithms for primary and secondary prevention are included This guideline includes NICE CG146 August 2012 fragility fracture risk Following safety concerns with strontium. MHRA (March 2014) advises that strontium for the treatment of severe osteoporosis in post-menopausal women and men with a high risk of fracture, should only be prescribed to patients who do not have a history of heart problems and if the patient is unable to take other medicines for this condition. Page 1 of 8

2 Document updates Date updated MHRA update strontium Vol 6 issue 9 May 2013 Further updated advice on strontium March 2014 Page 2 of 8

3 Derbyshire Minimum Standard Guidelines for Osteoporosis There is a minimum of activity that all practices should be considering. PRIORITY these patients should currently be on treatment and considered for investigation if appropriate: Osteoporotic fragility fractures, sustained from a fall from standing height or less, one or more fractures of the spine without major trauma Corticosteroid users, patients on or commencing systemic corticosteroid therapy (at any dose) for 3 months or longer. DEXA scanning may be used to guide therapy especially in patients under 65 years. Untreated early menopause, cessation of ovarian function at age 45 years or younger. Patients with independent clinical risk factors for fracture, including a parental history of hip fracture, a high alcohol intake of 4 units or more per day or rheumatoid arthritis, should be assessed for treatment see algorithms. Other indicators of low BMD that may warrant assessment include: Secondary amenorrhoea > 1 year Untreated hypogonadism (men and women) Prolonged use of Depo-provera > 3 years Malabsorption, including coeliac disease Chronic renal disease Chronic liver disease Primary Hyperparathyroidism Hyperthyroidism Ankylosing spondylitis Cushing s Syndrome Prolonged immobilisation Post transplantation Crohn s disease Low BMI < 22 kg/m 2 Radiological osteopenia Remember osteoporosis may occur in those with no risk factors. Investigations for osteoporosis if underlying causes are suspected. This is especially important in patients with vertebral fractures. FBC, ESR Ca, P, Alk Phos LFT Creatinine TSH If indicated: Malabsorption, malignancy, inflammatory disease Osteomalacia, hyperparathyroidism, bone metastases Liver disease Renal disease Hyperthyroidism Lumbar/thoracic spine x-rays Serum electrophoresis Urine Bence Jones Protein Isotope bone scan FSH Testosterone, LH, SHBG Fractures Myeloma Myeloma Bone metastases If hormone status not clear in women Hypogonadism in men Up to 50% of men have secondary causes. Specialist referral may be appropriate. Risk assessment tools QFracture and FRAX (without BMD) are useful screening tools to identify appropriate patients that are at risk of primary osteoporosis that GPs may be considering for dexa referral. These risk assessment tools should not be used for diagnosis of osteoporosis and prescribers should continue to follow NICE TA160 (see below). Tools can be accessed: QFracture- FRAX- Page 3 of 8

4 Drugs for the treatment and management of osteoporosis Calcium and Vitamin D Strong recommendation to prescribe for mobile elderly (over 65) who are largely housebound or living in residential or nursing homes. (Consider annual vitamin D injection 150, ,000 IU if compliance is a problem). All ambulatory women of 80 years and over in the community with low dietary intake of calcium and vitamin D should receive supplementation. All ambulatory women aged 70 years or over in the community with low dietary intake of calcium and vitamin D and a prior fracture should receive supplementation. Consider for other ambulatory over 65s if they have other risk factors such as current smoker, parental history of fracture, osteopenia, propensity to fall, slender build (low body weight < 58 kilos) with low dietary intake of calcium and vitamin D. Any patients known to be, or strongly suspected to be vitamin D deficient (e.g. malabsorption syndromes) should receive supplementation. Strong recommendation to prescribe for those on or commencing systemic corticosteroid therapy (at any dose) for 3 months or longer. Adcal-D3, one tablet twice daily is a suitable prescription. As the dose is supplemental and not pharmacological, routine monitoring is not thought necessary except in patients with renal impairment where caution is advised. Avoid in patients with hypercalcaemia, metastatic calcification and a history of calcific renal stones. Bisphosphonates Follow NICE guidance see algorithms Alendronate once-weekly is the recommended product. Consider for patients with osteoporosis and a vertebral fracture. It is important to exclude other secondary causes of vertebral fracture. Consider if a patient is on or commencing systemic corticosteroid therapy (at any dose) for 3 months or longer. DEXA scanning may guide therapy in patients particularly under the age of 65 years. Treatment is likely to be more effective if calcium and vitamin D is also given. Local consensus is to prescribe treatment for five years and to review the need for treatment thereafter. Alendronate and risedronate are best taken at least half an hour before the first food or drink (except water) in the morning. Patients should not lie down or return to bed after taking the medication. For Didronel PMO, the etidronate component should be taken in the middle of a 4 hour fast (e.g. last thing before bed after a 2 hour fast) for 14 days the calcium component is taken with food for a further 11 weeks and the cycle is repeated. Do not prescribe continuous etidronate (Didronel caps) as this is associated with an increased risk of fracture. Strontium ranelate This is an oral treatment option for second-line use in patients intolerant of the bisphosphonates in line with NICE guidance see algorithms Patients should also receive supplemental calcium and vitamin D if dietary intake is inadequate. MHRA April 2013 has raised the risk of serious cardiac disorders- restricted indications, new contraindications, and warnings. It should not be used in patients with: IHD, peripheral arterial disease; cerebrovascular; a history of these conditions; or in patients with uncontrolled hypertension. Further advice by the MHRA in March 2014 advised that strontium should only be prescribed to patients who do not have a history of heart problems and if the patient is unable to take other medicines for this condition. The EMA also advised that the patients risk of developing cardiovascular disease should be evaluated before starting treatment and on a regular basis thereafter, generally every 6 to 12 months. Raloxifene Is an alternative to a bisphosphonate in a postmenopausal female, only in secondary prevention in line with NICE guidance see treatment algorithms. It may make menopausal symptoms worse. Treatment is likely to be more effective if calcium and vitamin D is also given. Page 4 of 8

5 HRT HRT is no longer routinely recommended for the prevention or treatment of osteoporosis in women over the age of 50 years and its prescription should be reviewed. RCT evidence shows limited fracture reduction in current or very recent users, if taken for 5 years or more. It seems likely that once women have stopped treatment their risk of fracture soon returns to normal. In premature menopause (natural or surgical) consider HRT up to the age of 50. Parathyroid hormone (teriparatide) This is licensed for the treatment of osteoporosis but should be reserved for specialist advice. It has been designated a RED drug in Derbyshire. Page 5 of 8

6 NICE TAG 160 Primary Prevention of osteoporosis fragility fractures This guidance relates only to treatments for the primary prevention of fragility fractures in postmenopausal women who have osteoporosis. Osteoporosis is defined by a T-score of -2.5 standard deviations (SD) or below on dual-energy x-ray absorptiometry (DXA) scanning. However, the diagnosis may be assumed in women aged 75 years or older if the responsible clinician considers a DXA scan to be clinically inappropriate or unfeasible. Postmenopausal women younger than 65 with an independent clinical risk factor* and at least one additional indicator of low BMD # and confirmed osteoporosis Women aged with an independent clinical risk factor for fracture* and confirmed osteoporosis Women aged 70+ with an independent clinical risk factor for fracture* or an indicator of low BMD # and confirmed osteoporosis (women aged 75+ with 2 or more risk factors* or indicators of low BMD # may not require a DXA scan) Alendronate** once-weekly tabs 70mg Intolerance 1 of or contraindication to alendronate Risedronate** but only if these criteria are met: T-scores (SD) at (or below) which risedronate is recommended when alendronate cannot be taken Number of independent clinical risk factors* for fracture Age (years) a or older a Treatment with risedronate is not recommended Intolerance 1 of or contraindication to alendronate or risedronate Strontium ranelate** but only if these criteria are met: T-scores (SD) at (or below) which strontium ranelate is recommended when alendronate and risedronate cannot be taken Number of independent clinical risk factors* for fracture Age (years) a or older a Treatment with strontium ranelate is not recommended. Strontium ranelate is now restricted to the treatment of severe osteoporosis in postmenopausal women, who cannot use other osteoporosis treatments due to, contraindications or intolerance. Risk of developing cardiovascular disease should be assessed before starting treatment. Raloxifene is not recommended as a treatment option for the primary prevention of osteoporotic fragility fractures in postmenopausal women. 1. Unable to comply with the special instructions for administration or persistent upper gastrointestinal disturbance that is sufficiently severe to warrant discontinuation of treatment, and that occurs even though the instructions for administration have been followed correctly. *Independent clinical risk factors for fracture are parental history of hip fracture, alcohol intake of 4 or more units per day, and rheumatoid arthritis (RA).# indicators of low BMD are low BMI (<22kg/m2), medical conditions such as ankylosing spondylitis, RA, Crohn s disease, conditions that result in prolonged immobility, and untreated premature menopause. ** This guidance assumes that women who receive treatment have an adequate calcium intake and are vitamin D replete. Unless clinicians are confident that women who receive treatment meet these criteria, calcium and/or vitamin D supplementation should be considered (calcium 1200mg +vit D3 800 units daily recommended locally). Page 6 of 8

7 NICE TAG 161 Secondary Prevention of osteoporosis fragility fractures This guidance relates only to treatments for the secondary prevention of fragility fractures in postmenopausal women who have osteoporosis and have sustained a clinically apparent osteoporotic fragility fracture. Osteoporosis is defined by a T-score of -2.5 standard deviations (SD) or lower on dual-energy X-ray absorptiometry (DXA) scanning. However, the diagnosis may be assumed in women aged 75 years or older if the responsible clinician considers a DXA scan to be clinically inappropriate or unfeasible. Alendronate # once-weekly tabs 70mg Intolerance 1 of or contraindication to alendronate Risedronate # but only if these criteria are met: T-scores (SD) at (or below) which risedronate is recommended when alendronate cannot be taken Number of independent clinical risk factors for fracture* Age (years) a or older a Treatment with risedronate is not recommended. Intolerance 1 of or a contraindication to alendronate and risedronate Strontium ranelate # or raloxifene # but only if these criteria are met: T-scores (SD) at (or below) which strontium ranelate or raloxifene is recommended when alendronate and risedronate cannot be taken Number of independent clinical risk factors for fracture* Age (years) a or older a Treatment with raloxifene or strontium is not recommended. Strontium ranelate is now restricted to the treatment of severe osteoporosis in postmenopausal women, who cannot use other osteoporosis treatments due to, contraindications or intolerance. Risk of developing cardiovascular disease should be assessed before starting treatment. * Independent clinical risk factors for fracture are parental history of hip fracture, alcohol intake of 4 or more units per day, and rheumatoid arthritis. # This guidance assumes that women who receive treatment have an adequate calcium intake and are vitamin D replete. Unless clinicians are confident that women who receive treatment meet these criteria, calcium and/or vitamin D supplementation should be considered (calcium 1200mg + vit D units daily recommended locally). Teriparatide # is recommended as an alternative treatment option for secondary prevention only in those who are unable to take alendronate and risedronate, or have a contraindication to or are intolerant¹ of alendronate and risedronate, or who have a contraindication to, or are intolerant² of strontium ranelate, or who have had an unsatisfactory response³ to treatment with alendronate and risedronate and who are 65 years or older and have a T-score of -4.0 SD or below, or a T-score of -3.5 SD or below plus more than two fractures, or who are aged years and have a T-score of -4 SD or below plus more than two fractures. 1. Unable to comply with the special instructions for administration or persistent upper gastrointestinal disturbance that is sufficiently severe to warrant discontinuation of treatment, and that occurs even though the instructions for administration have been followed correctly. 2. Intolerance of strontium ranelate is defined as persistent nausea or diarrhoea, either of which warrants discontinuation of treatment. 3. An unsatisfactory response is defined as occurring when a woman has another fragility fracture despite adhering fully to treatment for 1 year and there is evidence of a decline in BMD below her pre-treatment baseline. Page 7 of 8

8 Falls prevention in the elderly Multidisciplinary intervention can reduce falls risk. Since the majority of low trauma non-vertebral fractures result from falls, this might be expected to reduce fracture rates. OTHER USEFUL INFORMATION Prevalence of Osteoporosis The lifetime risk of a 50 year old woman sustaining an osteoporotic fracture is about 40%. In men it is about 13%. Consequences of Hip Fracture One in five die following hip fracture Only 50% of survivors regain independence HRT risk and benefits From the Women s Health Initiative study Events caused per 10,000 patient years: CHD (non-fatal MI and CHD death) 7 Stroke 8 Breast cancer 8 VTE 18 Events prevented per 10,000 patient years: Hip fracture 5 Colorectal cancer 6 This is a net risk/benefit profile of 30 bad events caused by HRT. The following points should be made to the patient. They can be put onto paper for the patient to take away. Facts about Osteoporosis Osteoporosis means thin bones that break more easily It is not painful except when a bone is broken It is very common especially in women Often there is no particular cause The only way it could affect you is if you broke a bone because it got thin We can stop bones getting thinner with treatment Following your treatment regularly may stop this from happening Leading a healthy lifestyle with plenty of calcium in your diet, taking regular exercise and avoiding smoking and excess alcohol might reduce the risk of breaking a bone. References NICE Technology Appraisal Guidance 160 and 161, October 2008 JAMA 2005; 293: N Engl J Med 2004; 350: Glucocorticoidinduced osteoporosis guidelines for prevention and treatment. Royal College of Physicians December 2002 N Engl J Med 1997; 337: 6706 BMJ 1994; 308: NICE CG 146 : Fragility fracture risk August 2012 Page 8 of 8