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,

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

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

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.”

Bone Structure

Reduced minerals osteoid connectivity

Lifetime Changes in Bone Mass

AGE

Bone Mass

40 60 8020

Men

Women

Peak Bone Mass

Age Related Bone Loss

Menopausal Bone Loss

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)

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%

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.

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

Bone Strength

Bone Density

Bone Quality mineralisation

Bone Architecture connectivity

Bone Turnover Pagets

Geometry of Skeleton postural changes with age

racial differences

Postural Changes with Osteoporosis

Force Applied

Postural Instability Body Sway

Frailty Slow Response Time Environment BMI

Bone Density Determinants

AgeSmokingAlcoholExerciseDietary calciumWeightSunlight exposure/vitamin D

80% genetic factors20% environmental or lifestyle factors

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

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

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.

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

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.

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

FRAX WHO Fracture Risk Assessment Tool

www.shef.ac.uk/FRAX

FRAX Calculation Tool

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

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

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

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

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

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

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.

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.

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.

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

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.

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

Case Study JB

JB Male

JB male and BMD

JB male BMD and FH

JB female BMD and FH

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.