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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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UNIVERSITY of DERBY
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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UNIVERSITY of DERBY
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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UNIVERSITY of DERBY
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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UNIVERSITY of DERBY
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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UNIVERSITY of DERBY
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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UNIVERSITY of DERBY
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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UNIVERSITY of DERBY
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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UNIVERSITY of DERBY
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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UNIVERSITY of DERBY
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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UNIVERSITY of DERBY
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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UNIVERSITY of DERBY
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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UNIVERSITY of DERBY
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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UNIVERSITY of DERBY
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
UNIVERSITY of DERBY
UNIVERSITY of DERBY
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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UNIVERSITY of DERBY
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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UNIVERSITY of DERBY
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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UNIVERSITY of DERBY
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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UNIVERSITY of DERBY
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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UNIVERSITY of DERBY
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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UNIVERSITY of DERBY
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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UNIVERSITY of DERBY
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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UNIVERSITY of DERBY
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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UNIVERSITY of DERBY
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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UNIVERSITY of DERBY
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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UNIVERSITY of DERBY
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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UNIVERSITY of DERBY
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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UNIVERSITY of DERBY
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.
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