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What is it ? Why is it important? How do we do it? Dr Wendy M Carr General Practitioner, Newcastle upon Tyne Hospital Practitioner, Freeman Hospital 2008.

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Presentation on theme: "What is it ? Why is it important? How do we do it? Dr Wendy M Carr General Practitioner, Newcastle upon Tyne Hospital Practitioner, Freeman Hospital 2008."— Presentation transcript:

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2 What is it ? Why is it important? How do we do it? Dr Wendy M Carr General Practitioner, Newcastle upon Tyne Hospital Practitioner, Freeman Hospital 2008 Osteoporosis,

3 Osteoporosis ‘…a systemic skeletal disease characterised by low bone mass and microarchitectural deterioration of bone tissue, with consequent increase in bone fragility and susceptibility to fracture’ RCP, WHO 1994 Common sites of fracture Spine Neck of femur Wrist Definition Humerus

4 BMD Diagnostic Thresholds  NormalT score ≥-1 SD  Osteopaenia T-score ≤ -1 SD and >-2.5 SD  Osteoporosis T score ≥-2.5 SD  Severe / Established Osteoporosis Denotes osteoporosis as defined above along with 1 or more fragility fractures. Fracture risk increases by a factor of 2 for every 1 SD decrease in BMD For any BMD the fracture risk is higher in the elderly than in the young. (age is independent risk factor) Established WHO descriptive categories

5 The importance of Osteoporosis lies in the Fragility Fractures that are associated with it. WHO has quantified this as forces equivalent to a fall from standing height or less. Wrist hip vertebrae humerus Why is Osteoporosis Important ? BOA-BGS Blue Book 2007 “osteoporosis is a chronic disease with fracture as the acute exacerbation.”

6 Bone Structure Reduced minerals osteoid connectivity

7 Lifetime Changes in Bone Mass AGE B o n e M a s 4060 80 20 Men Women Peak Bone Mass Age Related Bone Loss Menopausal Bone Loss

8 Epidemiology  1 in 3 women and 1 in 12 men over the age of 50 are affected by osteoporosis.  In the UK there are annually 180,000 osteoporosis related fractures,  70,000 hip fractures,  41,000 wrist fractures  25,000 vertebral fractures. (higher as only 1/3 detected)  Combined risk of all types of fragility fractures coming to clinical attention is 40%. (equal to CVD risk)  In Caucasian women lifetime risk of hip fracture is 1 in 6. (breast cancer 1 in 9 lifetime risk)

9 Fracture Incidence Lifetime Fracture Risk at 50 years 10 Year Fracture Risk WomenMen 50 years 9.8% 50 years 7.1% 80 years 21.7% 80 years 8.0% WomenMen 53.2%20.7%

10 Costs of the Problem  Financial £££££££  Osteoporosis costs the NHS and Government over £1.7 billion each year in health and social care costs.  £5 million per day is spent on hospital in-patient care of those with osteoporotic fractures. 87% is related to hip fracture. 20% beds blocked  Physical  Pain, ↓mobility, ↓activity, further fracture  Psychological  ↓ confidence, ↑ worry about falling,↑ medication  Social  ↓ Independence, ↑ difficulty travelling, change in daily habits.

11 Risk of Fracture  Bone Density  Bone Quality mineralisation  Bone Architecture connectivity  Bone Turnover Pagets  Geometry of Skeleton postural changes with age racial differences Force Applied Bone Strength  Postural Instability Body Sway  Frailty  Slow Response Time  Environment  BMI

12 Bone Strength  Bone Density  Bone Quality mineralisation  Bone Architecture connectivity  Bone Turnover Pagets  Geometry of Skeleton postural changes with age racial differences

13 Postural Changes with Osteoporosis

14 Force Applied  Postural Instability  Body Sway  Frailty  Slow Response Time  Environment  BMI

15 Bone Density Determinants  Age  Smoking  Alcohol  Exercise  Dietary calcium  Weight  Sunlight exposure/vitamin D  80% genetic factors  20% environmental or lifestyle factors

16 Assessment of Fracture Risk BMD measured by DEXA But BMD not always available BMD detects bone density not fracture risk. BMD T score ≤ –2.5 = a high fracture risk But not all those with this BMD will fracture and most fractures occur in those with a T score > -2.5. Many other risk factors contribute to the risk of fracture some are partially dependent on BMD and some completely independent of BMD. More cost effective to treat on the basis of fracture risk than bone density

17 NICE Appraisal Process Appraisal Consultation Document May 2004 Appraisal Committee Meeting May 2004 Final Appraisal Determination Secondary Prevention July 2004 Appraisal Consultation Document Primary Prevention Feb 2007 FAD Secondary Prevention Feb 2007 ACD Secondary Prevention May 2005 Strontium Final Appraisal Determination Primary Prevention June 2007 FAD Secondary Prevention June 2007 Generic alendronate April 2008 NICE reviewed guidance on Primary and Secondary Prevention of Osteoporotic Fracture Appeal Upheld

18 Nice FA Secondary Prevention Who to Treat  Alendronic acid recommended in women with t score ≤ –2.5  ≥ 75 years DEXA may not be required.  Alternative treatments recommended if alendronic acid contraindicated or not tolerated but dependant on T scores and other risk factors.

19 NICE FA Primary Prevention Who to Treat ≥ 75 years with ≥ 2 risk factors a DXA scan may not be necessary ≥ 70 years T score of ≤ –2.5 ≥ 1clinical risk factors Or ≥ 1 risk factors for low BMD 65-69 years T score ≤ -2.5 and a clinical risk factor < 65 years T score ≤ -2.5 ≥ 1clinical risk factors and ≥ 1 risk factors for low BMD

20 NICE FA Primary Prevention Clinical Risk Factors  Parental Hip Fracture  Alcohol> 4 U per day  Severe long-term RA Risk factor for Low BMD  BMI<21  Medical Conditions  Prolonged Immobility  Premature menopause Risedronate and etidronate if alendronate contraindicated or not tolerated dependant on T scores and other risk factors. Strontium ranelate only recommended if woman unable to comply with instructions on bisphosphonate administration or where risedronate and etidronate contraindicated or not tolerated dependant on T score and other risk factors. Raloxifene and Teriparatide not recommended.

21 Assessment of Osteoporosis at the Primary Health Care Level  WHO technical report launched 21/2/2008  Related FRAX tool  Predicts the risk of osteoporosis related fracture using clinical risk factors  10 year fracture risk in men and women NO TREATMENT THRESHHOLDS

22 FRAX WHO Fracture Risk Assessment Tool www.shef.ac.uk/FRAX

23 FRAX Calculation Tool

24 WHO 2008 WHO Algorithm

25 Management of Osteoporosis Treatment / Secondary Prevention Lifestyle –Diet –Exercise –Smoking –Alcohol Intake –Sunlight Exposure Pharmacological –Drugs altering BMD –Analgesia Non-pharmacological –Physiotherapy –Pain Relief Falls Assessment Prevention / Primary Prevention Lifestyle –Diet –Exercise –Smoking –Alcohol Intake –Sunlight Exposure Pharmacological –Drugs altering BMD Non-pharmacological –Physiotherapy –Hip Protectors Prevention of Falls

26 Lifestyle Advice Diet Balanced diet containing adequate calcium 1000 mg/day Exercise Regular weight bearing exercise 3 times a week for 20 minutes minimum Smoking Stop smoking Alcohol Within safe limits – 2u/day women – 3u/day men Sunlight Exposure 15-20 minutes on face, hands and forearms twice weekly form April to October

27 Drug Therapies In the presence of normal calcium and Vitamin D levels Non-Hormonal  Bisphosphonates  Didronel PMO yes  Alendronate yes first line  Risedronate yes  Ibandronate no  Zoledronate no  Strontium Ranelate yes  Teriparatide no  Synthetic  SERM Raloxifene no Supported by NICE

28 Zoledronic Acid  Licensed for treatment of osteoporosis in post-menopausal women.  No more effective than other bisphosphonates.  Annual IV infusion of 5mg given over 15 mins.  Indications  Patients in whom oral bisphosph. are contraindicated or not tolerated.  Patients in whom concordance is an issue.  Contraindications  Atrial fibrillation (1.3% vs 0.5 % placebo up to 30 days post transfusion)  Cautions  Creatinine clearance/eGFR < 40  Ensure adequate calcium and VitD supplementation  No increased risk of ONJ  Financial and service delivery implications

29 Which Bisphosphonate ? Generic NameProprietary Name ManufacturerAnnual Cost EtidronateDidronel PMOP&G£85.65 Alendronic AcidGeneric£47.71 w £94.12 d RisedronateActonelP&G/Sanofi Aventis£264.62 w £248.98d IbandronateBonvivaRoche£257.40 Ibandronate IVBonvivaRoche£360 per year Zoledronic Acid IVAclastaNovartis£283.74 per year StrontiumProtelosServier£333.71 RaloxifeneEvistaEli Lilly£228.32 TeriparatideForesteoEli Lilly£3544.15 Calcium+Vitamin DAdcal D3ProStrakan£59.93 Calcichew D3 ForteShire£58.66 Calfovit D3Menarini£56.31 FosavanceMSD£297.91 Adcal D3 DissolveProStrakan£59.88

30 Newcastle PCT Medicines Management Alendronate is the bisphosphonate of choice in the treatment and prevention of osteoporosis unless  Patients with previous adverse effects to alendronate.  Premenopausal women and those under 50 years of age.  Patients with renal impairment eGFR <35ml/min.  Elderly patients where you do not know eGFR or serum creatinine (>125 at 80 years).  Patients with oesophageal abnormalities, dysphagia and symptomatic oesophageal disease.  Active peptic ulceration, gastritis or duodenitis.  Very elderly patients. (evidence better). North of Tyne 63% on alendronic acid 30% on risedronate and 7% on ibandronate UK 70% on alendronic acid.

31 NICE  Finalise the FADs  Need to publish clinical guidelines  Men and premenopausal women  Other groups at high risk  Women with osteopaenia Where now? WHO and FRAX  Decide upon and publish treatment thresholds (?Oct 2008)  Consider Falls NOG National Osteoporosis Group Interested groups joined together initially to appeal the NICE appraisals and now planning to bring out suggestions for thresholds for treatment in the near future ? what level Americans use 7%? 20% as with CVD Initial suggestions these will rise with increasing age counterintuitive but cost effective otherwise treat too many younger patients at low fracture risk or too few older people with high risk.

32 NICE  Finalise the FADs  Need to publish clinical guidelines  Men and premenopausal women  Other groups at high risk  Women with osteopaenia Where now? WHO and FRAX  Decide upon and publish treatment thresholds (?Oct 2008)  Consider Falls NOG National Osteoporosis Group Interested groups joined together initially to appeal the NICE appraisals and now planning to bring out suggestions for thresholds for treatment in the near future ? what level Americans use 7%? 20% as with CVD Initial suggestions these will rise with increasing age counterintuitive but cost effective otherwise treat too many younger patients at low fracture risk or too few older people with high risk.

33 Osteoporosis and the Near Future Groups for whom OP Assessment will become increasingly important Oral Glucocorticoid treated patients  Transplant patients  Inflammatory bowel disease  Asthma/COPD Renal Disease / Hepatic Disease Hormonal Manipulation (+ effects of surgery chemotherapy and radiotherapy  Breast cancer  Prostate cancer Immobility  CVA  PD/MS patients  Young neurological rehabilitation patients

34 Local Progress Newcastle North and East Locality PBC Group Successful SIF bid for an Osteoporosis Project Prescribing Ca/vitD for those in Residential and Nursing Care Assessing those with previous fractures over the age of 50 years and starting bone preserving medication if these are fragility fractures West Locality PBC Group Looking at setting up annual zolandronate infusions for those with high fracture risk and osteoporosis both in Residential and Nursing Care and in the community.

35 Clinical case JB Male 73 years Risk Factor Assessment 1998 # R NOF # R humerus in traumatic fall 2007 wedge fracture noted on chest x-ray Back pain constant mild and continuous Aching in R hip R knee L knee Weight 88 kg Height 1.67 Height loss no Kyphosis no Hypothyroid on replacement rx FH fracture no Smoker 10/day since 16 years of age Alcohol no Diet limited dairy and green vegetable intake Some time in garden in summer months Exercise walks every day ½ mile for paper PMH Hypertension Gout Hypothyroidism Heart Failure Previous MI Medication Simvastatin Bisoprolol Allopurinol Perindopril Aspirin Lansoprazole Levothyroxine Femoral neck T score –3.7 Lumbar T score –2.2

36 Case Study JB

37 JB Male

38 JB male and BMD

39 JB male BMD and FH

40 JB female BMD and FH

41 Osteoporosis in Primary Care  Osteoporosis is common. It is a disease of old age, the incidence will rise as the population ages.  Importance lies in the fractures that are associated with it but bone density is only one factors which determines fracture risk.  Guidelines and tools to help asses fracture risk are slowly being developed.  Threshholds will need to be set depending on health economics and levels of cost-effectiveness  Should be considered and managed in the same way as CHD and we in Primary Care are good at managing Chronic Disease.  Falls risk still need to be factored in.  Many effective therapies available.


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