what is it ? why is it important? how do we do it? dr wendy m carr general practitioner, newcastle...
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What is it ?
Why is it important? How do we do it?
Dr Wendy M CarrGeneral Practitioner,
Newcastle upon Tyne
Hospital Practitioner,
Freeman Hospital
2008
Osteoporosis,
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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
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BMD Diagnostic Thresholds
Normal T score ≥-1 SDOsteopaenia T-score ≤ -1 SD and >-2.5 SD
Osteoporosis T score ≥-2.5 SD
Severe / Established OsteoporosisDenotes 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
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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.”
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Bone Structure
Reduced minerals osteoid connectivity
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Lifetime Changes in Bone Mass
AGE
Bone Mass
40 60 8020
Men
Women
Peak Bone Mass
Age Related Bone Loss
Menopausal Bone Loss
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Epidemiology1 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)
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Fracture Incidence Lifetime Fracture Risk at 50 years
10 Year Fracture Risk
Women Men
50 years 9.8% 50 years 7.1%
80 years 21.7% 80 years 8.0%
Women Men
53.2% 20.7%
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Costs of the ProblemFinancial £££££££
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.
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Risk of Fracture
Bone Density Bone Quality mineralisation
Bone Architecture connectivity
Bone Turnover Pagets
Geometry of Skeleton postural changes with age
racial differences
Force AppliedBone Strength
Postural Instability Body Sway
FrailtySlow Response TimeEnvironmentBMI
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Bone Strength
Bone Density
Bone Quality mineralisation
Bone Architecture connectivity
Bone Turnover Pagets
Geometry of Skeleton postural changes with age
racial differences
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Postural Changes with Osteoporosis
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Force Applied
Postural Instability Body Sway
Frailty Slow Response Time Environment BMI
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Bone Density Determinants
AgeSmokingAlcoholExerciseDietary calciumWeightSunlight exposure/vitamin D
80% genetic factors20% environmental or lifestyle factors
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Assessment of Fracture RiskBMD measured by DEXA But
BMD not always availableBMD 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
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NICE Appraisal ProcessAppraisal Consultation Document May 2004
Appraisal Committee Meeting May 2004
Final Appraisal Determination Secondary Prevention
July 2004Appraisal 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 FractureAppeal Upheld
Appeal Upheld
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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.
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NICE FA Primary PreventionWho 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
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NICE FA Primary PreventionClinical 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.
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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
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FRAX WHO Fracture Risk Assessment Tool
www.shef.ac.uk/FRAX
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FRAX Calculation Tool
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WHO 2008
WHO Algorithm
Treat
H igh R isk
Treat
H igh R isk Low R isk
R eassess F racture P robab ility
A ssess B M D
Interm edia teR isk Low R isk
C lin ica l R isk Factors
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Management of OsteoporosisTreatment / 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
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Lifestyle AdviceDiet
Balanced diet containing adequate calcium
1000 mg/day
ExerciseRegular weight bearing exercise 3 times
a week for 20 minutes minimum
SmokingStop smokingAlcohol
Within safe limits–2u/day women–3u/day men
Sunlight Exposure15-20 minutes on face, hands and forearms twice weekly form April to October
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Drug Therapies
In the presence of normal calcium and Vitamin D levels
Non-Hormonal Bisphosphonates
Didronel PMO yesAlendronate yes first lineRisedronate yesIbandronate noZoledronate no
Strontium Ranelate yes Teriparatide no
Synthetic SERM Raloxifene no
Supported by NICE
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Zoledronic AcidLicensed 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 ONJFinancial and service delivery implications
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Which Bisphosphonate ?Generic Name Proprietary
NameManufacturer Annual Cost
Etidronate Didronel PMO P&G £85.65
Alendronic Acid Generic £47.71 w £94.12 d
Risedronate Actonel P&G/Sanofi Aventis £264.62 w £248.98d
Ibandronate Bonviva Roche £257.40
Ibandronate IV Bonviva Roche £360 per year
Zoledronic Acid IV Aclasta Novartis £283.74 per year
Strontium Protelos Servier £333.71
Raloxifene Evista Eli Lilly £228.32
Teriparatide Foresteo Eli Lilly £3544.15
Calcium+Vitamin D Adcal D3 ProStrakan £59.93
Calcichew D3 Forte Shire £58.66
Calfovit D3 Menarini £56.31
Fosavance MSD £297.91
Adcal D3 Dissolve ProStrakan £59.88
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Newcastle PCT Medicines ManagementAlendronate 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.
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NICE Finalise the FADsNeed to publish clinical guidelines
Men and premenopausal womenOther groups at high riskWomen with osteopaenia
Where now?
WHO and FRAXDecide upon and publish treatment thresholds (?Oct 2008)Consider Falls
NOG National Osteoporosis GroupInterested 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 butcost effective otherwise treat too many younger patients at low fracture risk or too few older people with high risk.
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NICE Finalise the FADsNeed to publish clinical guidelines
Men and premenopausal womenOther groups at high riskWomen with osteopaenia
Where now?
WHO and FRAXDecide upon and publish treatment thresholds (?Oct 2008)Consider Falls
NOG National Osteoporosis GroupInterested 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 butcost effective otherwise treat too many younger patients at low fracture risk or too few older people with high risk.
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Osteoporosis and the Near FutureGroups for whom OP Assessment will become increasingly important
Oral Glucocorticoid treated patientsTransplant patientsInflammatory bowel diseaseAsthma/COPD
Renal Disease / Hepatic Disease
Hormonal Manipulation (+ effects of surgery chemotherapy and radiotherapyBreast cancerProstate cancer
ImmobilityCVAPD/MS patientsYoung neurological rehabilitation patients
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Local Progress
Newcastle North and East Locality PBC GroupSuccessful 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 GroupLooking at setting up annual zolandronate infusions for those with high fracture risk and osteoporosis both in Residential and Nursing Care and in the community.
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Clinical case JB Male 73 years Risk Factor Assessment1998 # 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
PMHHypertensionGout HypothyroidismHeart FailurePrevious MI
Medication Simvastatin BisoprololAllopurinolPerindoprilAspirinLansoprazoleLevothyroxine
Femoral neck T score –3.7Lumbar T score –2.2
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Case Study JB
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JB Male
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JB male and BMD
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JB male BMD and FH
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JB female BMD and FH
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Osteoporosis in Primary CareOsteoporosis 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.