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The evidence

What is the prevalence of fragility fracture

1

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2

Estimated or measured prevalence of females ≥ 50 with prior fragility fracture years

0

5

10

15

20

25

30

35

Qresearch (1) Lanarkshire (2) Australia (3) Canada (4) France (5)

Per

cen

tag

e

1 Hippis;ley-Cox, J et al. (2007) Information Centre. 2 Brankin, E. et al. (2005) CMRO. 3 Eisman, J. et al. (2004) Journal of Bone and Mineral Research. 4 Leslie, W. D. et al (2007) Bone. 5 Amamra, N. et al (2004) Joint Bone Spine.

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The evidence

Are the right patients getting treatment?

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4

Secondary prevention following fragility fracture in British primary care (n= 3.4 million)

17.0

9.8

25.3

73.0

1.8

4.8

43.6

0 10 20 30 40 50 60 70 80 90 100

Males > 65 + prior # + OP on Rx

Males > 65 + prior # + OP

Males > 65 + prior # + DXA

Females 65-74 + prior # + OP on Rx

Females 65-74 + prior # + OP

Females 65-74 + prior # + DXA

Females ≥ 75 + prior # on treatment

Percentage

Hippisley-Cox, J., Bayly, J., Potter, J., Fenty, J. & Parker, C. (2007) Evaluation of standards of care for osteoporosis and falls in primary care. The Health and Social Care Information Centre.

n = 7860/31094

n = 1476/15025

n = 2551/15025

n = 1862/2551

n = 261/14651

n = 700/14651

n = 305/700

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5National Clinical Audit of Falls and Bone Health (2007) Clinical Effectiveness and Evaluation Unit, RCP, London

Interventions following low trauma fracture Oct-Dec 2006 (England, Wales and NI)

n=8826

0

10

20

30

40

50

60

Osteoporosisassessment

DXA referral (65-74years)

Supplementationwith calcium + D3

Treatment withosteoporosismedication

Per

cent

age

hip (n = 3184)

non-hip (n = 5642)

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6

Many hip fractures have had a prior fragility fracture

Percentage of patients with hip fracture reporting prior fragility fracture

45.3 44.6 45.4

0.0

10.0

20.0

30.0

40.0

50.0

60.0

70.0

80.0

90.0

100.0

Lyles et al Edwards et al Mclellan et al

Per

cent

age

Lyles KW et al. The Horizon Recurrent Clinical Fracture after Recent Hip Fracture Trial (RFT) Study Cohort Description. ASBMR 2006

Edwards, B. J. et al (2007) Prior Fractures Are Common in Patients With Subsequent Hip Fractures. Clinical Orthopaedics & Related Research, 461, 226-230

McLellan Alastair R. et al.(2004) Effectiveness of Strategies for the Secondary Prevention of Osteoporotic Fractures in Scotland (CEPS 99/03). NHS Quality Improvement Scotland.

n=2124 n=632 n=701

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7

Many non-hip fractures have had a prior fragility fracture

Forearm fracture Vertebral fracture0

10

20

30

40

50

60

70

80

90

100

n = 919 N = 443

31.8%

49.9%

%

McLellan Alastair R. et al.(2004) Effectiveness of Strategies for the Secondary Prevention of Osteoporotic Fractures in Scotland (CEPS 99/03). NHS Quality Improvement Scotland.

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8

RCP-CEEU national organisational auditFalls and bone health services 2009

• “Important public health information on fracture rates is inadequate or not collated

• “Only 39% of commissioning Trusts report being compliant with the NICE technology appraisal on secondary prevention of osteoporotic fragility fractures” In the Annual Health Check 95% do.

• “This public reassurance about fracture prevention services turns out to be misleading, since only 24% (40/169) of PCOs have audited local bone health prescribing and only 9 know their local fragility fracture rates”.

• Only 24% of Trusts have a Fracture Liaison Service• Recommendations for adherence to NICE treatment guidelines

with monitoring by local audit, and a Fracture Liaison Service

National Audit of the Organisation of Services for Falls and Bone Health for Older People. 2009. Available for download from: http://www.rcplondon.ac.uk/clinical-standards/ceeu/Current-work/Falls/Pages/Audit.aspx#round2_audit_2008

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Primary Prevention

9

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10

0

5000

10000

15000

20000

25000

30000

35000

40000

45000

Strong clinical risk factors(CRF)

Strong CRF + DXA orassessment (3yr)

Strong CRF + osteoporosis Strong CRF + osteoporosison Rx

2.8%

62.2%

12.5%

Primary prevention: aspects of management in 312,517 over 65 year old women with strong clinical risk factors for osteoporosis

Hippisley-Cox, J., Bayly, J., Potter, J., Fenty, J. & Parker, C. (2007) Evaluation of standards of care for osteoporosis and falls in primary care. The Health and Social Care Information Centre.

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The Residential and Nursing Care Home Population

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12

The residential and nursing care home environment Hip fracture risk 3-4 fold higher

Brennan J et al. Osteoporos Int (2003) 14:515-9Norton R et al. Age and Ageing (1999) 28:135-9

Osteoporosis is common – 70% Falls risk is high

Rubenstein LZ et al Ann Int Med (1994) 121:442-51

Calcium and D3 prescription is uncommon – 12% at best Definitive treatment is virtually non-existent

Aspray T et al. Age and Ageing (2006) 35: 37-41

The number of older people in institutions will rise by 57% by the year 2031, from nearly 400,000 to 627,000

PSSRU, July 2003

This is an easily identifiable but poorly coded population on GP systems: even amongst those on GP registers, only 1 in 3 receive calcium and D3.

Hippisely-Cox et al. Information Centre (2006)

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13

27.421.1

27.4

46.3

0

10

20

30

40

50

60

70

80

90

100

Proportion on calcium/D3

Over 75 with f ragility f racture

Secondary prevention GCIOP risk on treatment

Per

cent

age

RNCH care standards (Gloucestershire 2009) n = 3,040/4,500, mean age 86.3

368/1745834/3040 101/368 44/95

Mayes N, Walker K, Bayly J R. Evaluating and Improving Clinical Standards in the Management of Fracture Risk in Older People in Residential Care Settings. J Bone Miner Res . 2009;24 (Suppl 1):SU0397.

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Trends in Falls admissions

14

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15

New Contract

Estimated Falls Admissions in England related to frailty in over 60 year olds 1999-2008

Codes W00, W01, W04-8, W010, W018-19

0

50,000

100,000

150,000

200,000

250,000

98-99 99-00 00-01 01-02 02-03 03-04 04-05 05-06 06-07 07-08 08-09

* Estimated from ratio of FCEs by age

HES source data: Copyright © 2009, Re-used with the permission of The Health and Social Care Information Centre. All rights reserved

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16

Aspects of integrated falls care in patients 75 and over (n = 270,028)

0

0.2

0.4

0.6

0.8

1

1.2

1.4

1.6

1.8

2

Documentedenquiry about no.

falls

High risk fallers High risk fallerswith documented

referral

High risk fallersassessed forosteoporosis

Fragility fracturepatients assessed

for falls

Percentage

Hippisley-Cox, J., Bayly, J., Potter, J., Fenty, J. & Parker, C. (2007) Evaluation of standards of care for osteoporosis and falls in primary care. The Health and Social Care Information Centre.

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Do we have the right model for fallers clinics and falls services?

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18

SDO systematic review of falls clinics

….. the current evidence base cannot be interpreted as a foundation for the widespread implementation of the Falls Prevention Programmes to reduce the incidence of falls related injuries and the associated morbidity, mortality and resource use

Lamb S et al. Scoping Exercise on Fallers’ Clinics: Report to the National Co-ordinating Centre for NHS Service Delivery and Organisation R & D (NCCSDO), 2007.

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19

SDO systematic review of falls clinics Small effect on falls incidence (RR 0.9, CI 0.8-1.0) No effect on

– falls related injuries including fracture (0.97, CI 0.73-1.28)

– mortality (RR 1.0, CI 0.78-1.27)– transition to institutional care (RR 0.92, CI 0.66-1.29)– A and E attendance (RR 0.98, CI 0.74-1.29)– Hospital admissions (RR 0.98, CI 0.69-1.04)

Do increase GP attendances ( RR 1.38, CI 1.11-1.74) Little good quality evidence about the performance of any

of the screening tools most commonly used by falls clinics in the UK

Cost/benefit analysis not possible

Lamb S et al. Scoping Exercise on Fallers’ Clinics: Report to the National Co-ordinating Centre for NHS Service Delivery and Organisation R & D (NCCSDO), 2007.

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20

What is the evidence for fallers’ clinic1

202 studies - 18 suitable for analysis No clear advantage

– by location/setting– by risk grading of patients– by presence of doctor

• Recurrent falls (4 studies) 34% reduction (RR 0.76; 0.58-0.99)

• The one study with a doctor - 66% reduction

• But falls services are only seeing 1.7 new patients/100,000/week2

1) Lamb S et al. Scoping Exercise on Fallers’ Clinics: Report to the National Co-ordinating Centre for NHS Service Delivery and Organisation R & D (NCCSDO), 2007. 2) Royal College of Physicians’ London. National Audit of the Organisation of Services for Falls and Bone Health for Older People. 2006.

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What is happening to the prescribing rate?

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22

Prescribed items: 28 day equivalents

Prescription Cost Analysis, NHS Information Centre http://www.ic.nhs.uk/statistics-and-data-collections/primary-care/prescriptions

Charts courtesy of P Mitchell

£ millions

0.0

1000.0

2000.0

3000.0

4000.0

5000.0

6000.0

7000.0

8000.0

1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008

Alendronate

Etidronate

Ibandronate

Risedronate

Zoledronate

Raloxifene

Teriparatide

Strontium

Market

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23

Prescribing costs attributable to bone re-modelling drugs

0.00

20.00

40.00

60.00

80.00

100.00

120.00

140.00

160.00

1998 1999 2000 2001 2002 2003 2004 2005 2006 2007

Alendronate

Etidronate

Ibandronate

Risedronate

Zoledronate

Raloxifene

Teriparatide

Strontium

Market

Prescription Cost Analysis, NHS Information Centre http://www.ic.nhs.uk/statistics-and-data-collections/primary-care/prescriptions

Charts courtesy of P Mitchell

£ millions

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24

Statins market

0.00

100.00

200.00

300.00

400.00

500.00

600.00

700.00

800.00

1998 1999 2000 2001 2002 2003 2004 2005 2006 2007

Simva

Atorva

Prava

Ceriva

Fluva

Rosuva

Market

£ millions

Charts courtesy of P Mitchell

Prescription Cost Analysis, NHS Information Centre http://www.ic.nhs.uk/statistics-and-data-collections/primary-care/prescriptions

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25

Admissions for Hip Fractures in England (ICD S72.0, 72.1 and 72.2)

50,000

52,000

54,000

56,000

58,000

60,000

62,000

64,000

66,000

1998-1999 1999-2000 2000-01 2001-02 2002-03 2003-04 2004-05 2005-06 2006-07 2007-08 2008-09

HES source data: Copyright © 2009, Re-used with the permission of The Health and Social Care Information Centre. All rights reserved

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26

Estimated Hospital Bed Days for Major Disease Areas (2008-09)

-

500,000

1,000,000

1,500,000

2,000,000

2,500,000

All fractures >60yr.*

Fracture femur>60 yr.*

Diabetes allages

Cardiacischaemia all

ages

Heart failure allages

COPD + asthmaall ages

Stroke >60 yr*

* Estimated from ratio of FCEs by age

HES source data: Copyright © 2009, Re-used with the permission of The Health and Social Care Information Centre. All rights reserved

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27

Estimated Hospital Bed Days for Major Disease Areas (2008-09)

-

500,000

1,000,000

1,500,000

2,000,000

2,500,000

3,000,000

3,500,000

4,000,000

4,500,000

5,000,000

All fractures>60 yr + falls

>75 yr.*

Fracturefemur >60 yr.*

Diabetes allages

Cardiacischaemia all

ages

Heart failureall ages

COPD +asthma all

ages

Stroke >60 yr*

* Estimated from ratio of FCEs by age

HES source data: Copyright © 2009, Re-used with the permission of The Health and Social Care Information Centre. All rights reserved

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Demographics: future trends

28

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29

Percentage of elderly in Europe

0

5

10

15

20

25

30

Percentage

2000 2015 2030 2050

Percentage of elderly as a proportion of population in Europe 2000-2050

65+

75+

80+

Source: OECD

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30

4.08 4.13 4.15

3.734.01

2.15 2.121.83

1.471.36

0

0.5

1

1.5

2

2.5

3

3.5

4

4.5

5

per

cen

tag

e

2000 2050

Potential Support Ratio, selected countries 2000 and 2050

France

UK

Germany

Italy

Spain

Source: Government Actuary Department

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31

UK population size required to maintain given PSRs: 2000-2100

0

50

100

150

200

250

300

350

2000 2010 2020 2025 2030 2050 2060 2080 2100

PSR 3.0 PSR 3.5 PSR 4.22

Source: Government Actuary Department

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32

The priority given to trauma and musculoskeletal disorders

GMS services

NHS spending Local variations in priorities: an update. The Kings Fund; September 2008

Trauma

Musculoskeletal

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.... and is that a good argument for a systems-based approach?

Could it be we are targeting the wrong patients?

33

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34

Proportion of patients on specific osteoporosis treatment with evidence of a recorded diagnosis

50.656.0

72.0

0

10

20

30

40

50

60

70

80

90

100

Qresearch Gloucestershire Stroud Valleys

Pe

rce

nta

ge

1 in 4 bisphosphonate prescriptions directed at those under age 65

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35The REAL study Silverman, S. et al. (2007). Osteoporosis International, 18, 25-34.

Cumulative hip fracture incidence in the REAL study

Pooled NNT = 570

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36

Comparison of baseline characteristics between cohorts in study

Characteristics Cohorts

Risedronate Alendronate

Osteoporosis diagnosis 37.7 33.8

Osteopenia diagnosis 12.5 10.5

Proportion of patients in REAL study with low BMD

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37Gallacher AM et al. Fracture Outcomes related to persistence and compliance with oral bisphosphonates. JBMR (2008) On line first

Adjusted fracture relative risk for persitent versus discontinued bisphosphonate users

0

0.2

0.4

0.6

0.8

1

1.2

1.4

rela

tive

risk

current use 0.85 0.78 0.66 0.77 1.04 0.92

osteoporotic hip/femur Hip femur* vertebra radius/ulna Humerus

Fractures (n) 2029 628 247 372 590 354

* More than 24 months persistence

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38

Are we treating the right populations?

Incident rate past users (100 py) 2.47 0.76 0.76 0.47 0.62 0.36"Baseline" 10 year # risk 0.247 0.076 0.076 0.047 0.062 0.036Treated incident rate 2.35 0.7 0.54 0.41 0.68 0.41ARR/year 0.12 0.06 0.22 0.06 -0.06 -0.05NNT/year 833 1667 455 1667 -1667 -2000

Adapted from Gallacher AM et al. Fracture Outcomes related to persistence and compliance with oral bisphosphonates. JBMR (2008) On line first

* More than 24 months persistence

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The need to consider more than just initiation of therapies

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40

0

1

2

3

4

5

6

7

0 2 4 6 8 10 12 14 16 18 20

Years of follow up

Abs

olut

e ris

k

Time dependency of re-fracture

First fracture

Second fracture

Van Geel T et al ASBMR 2008 and An Rheum Dis August 2008 On-line first

4140 post menopausal women age 50-90

23% re-fractures

54% re-fractures

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41

0

20

40

60

80

100

1 2 3 4 5 6 7 8 9 10 11 12

Daily alendronateWeekly alendronate

Persistence (continuous adherence): Daily or Weekly alendronate

Months of treatment

Per

cent

age

DIN-LINK Report: Osteoporosis - Report 4 [GSK_OSP_004.DN2]. May 2004

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42

Clinical Effectiveness

38,000 adults with ≥ 2 scripts for a BP (80% OAW, 75% ALN) on GPRD

43% > 70 years and 81% female58.3% persistent at 1 year, 23.6% at 5

yearsNo persistence of effect after

discontinuation

Gallacher AM et al. Fracture Outcomes related to persistence and compliance with oral bisphosphonates. JBMR (2008) On line first

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43

The fracture pyramid in the GP’s list for females over 50 years

Patients with new fragility # per year

Patients with prevalent fragility #

Prevalent postmenopausal Osteoporotics ± #

Postmenopausal women

10-14% intervention rate

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44

Mapping patients to policies to programmes

Hip fracture patients

Objective 1: Improve outcomes and improve efficiency of care after hip fractures – by following the 6 “Blue Book” standards

Non-hip fragility fracture patients

Objective 2: Respond to the first fracture, prevent the second – through Fracture Liaison Services in acute and primary care

Individuals at high risk of 1st fragility fracture or other

injurious falls

Objective 3: Early intervention to restore independence – through falls care pathway linking acute and urgent care services to secondary falls prevention

Older people

Objective 4: Prevent frailty, preserve bone health, reduce accidents – through preserving physical activity, healthy lifestyles and reducing environmental hazards

NSF, TA161, CG21, Blue Book & NHFD

NSF, TA161, CG21 & Blue Book

NSF, TA160& CG21

NSF

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45

By 2014 the cost of 10 year’s delay in implementing a systematic approach in the UK

300,000 hip fractures will have occurred with a history of a prior fragility fracture

If 20% (60,000) will have had guideline care (DXA or treatment)

If treatment reduces hip fracture risk by 33%. 240,000 patients not receiving care with 33% efficacy

equates to 80,000 preventable hip fractures per year …. or 2,000,000 bed days.  …. or with 20% mortality 16,000 potentially avoidable

deaths …. or with 40% dependency 32,000 unable to live

independently.