International Osteoporosis Foundation and European Society of Musculoskeletal Radiology Vertebral Fracture Initiative Slide Kit

1
International Osteoporosis FoundationEuropean
Society of Musculoskeletal Radiology
VERTEBRAL FRACTURE INITIATIVESlide Kit Part 1
Osteoporosis and Related Fractures An
Under-diagnosed and Under-treated Public Health
Issue
2
Why is the Vertebral Fracture Initiative needed?

• Most vertebral fractures are a complication of
  osteoporosis and increase the likelihood of
  subsequent fractures
• Currently mild and moderate vertebral fractures
  are often not being recognised and reported,
  leading to under-diagnosis and under-treatment
• Radiographic diagnosis is considered the best way
  to identify and confirm the presence of vertebral
  fractures in clinical practice
• All vertebral fractures identified should be
  reported as FRACTURED to avoid ambiguity caused
  by other terminology
• Early radiographic diagnosis followed by
  appropriate therapy will help prevent subsequent
  fractures

3
What is the Vertebral Fracture Initiative?

• An educational initiative to improve recognition
  and reporting of vertebral fractures Pilot
  phase in five European countries

Teaching Faculty

• Initiative Leaders Harry K. Genant Pierre D.
  Delmas
• France Jean-Denis Larédo Pierre D. Delmas
• Germany Helmut Minne Michael Jergas / Dieter
  Felsenberg
• Italy Silvano Adami Giuseppe Guglielmi
• Spain Jorge Cannata Francisco Aparisi
• UK David Reid Judith Adams
• A clinician and radiologist team taking the lead
  in each country

4
What does the Vertebral Fracture Initiative
include?

• 1. Presentations at radiology conferences
• 2. Articles in radiology related publications
• 3. A resource document and a slide kit
  including
• Part 1. Osteoporosis and Related Fractures An
  Under-diagnosed and Under-Treated Public Health
  Issue
• Part 2. Recognition and Reporting of Vertebral
  Fractures
• 4. Summary handout
• 5. Interactive teaching programme on CD-ROM
• Teaching tools available from www.osteofound.org

5
Definition of Osteoporosis

• A disease characterized by low bone mass and
  microarchitectural deterioration of bone tissue
  leading to enhanced bone fragility and a
  consequent increase in fracture risk.
• World Health Organization (WHO) , 1994

Normal bone
Osteoporosis
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OSTEOPOROSISTHE SIZE OF THE PROBLEM
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Osteoporosis is a Prevalent Disease

• Affects 200 million women worldwide1
• - 1/3 of women aged 60 to 70
• - 2/3 of women aged 80 or older
• Approximately 20-25 of women over the age of 50
  have one or more vertebral fractures2
• - United States 253
• - Australia 204
• - Western Europe 195
• - Scandinavia 265
• - Denmark 216

1. International Osteoporosis Foundation 4.
Jones G et al., Osteoporos Int 1996, 6233 2.
Melton LJ 3rd et al., Spine 1997, 222S 5.
O'Neill et al., J Bone Miner Res 1996, 111010 3.
Ettinger B et al., J Bone Miner Res 1992,7449 6.
Jensen GF et al., Clin Orthop 1982,16675
8
Incidence Rates for Vertebral, Wrist Hip
Fractures in Women after Age 50

• Wasnich RD, Primer on the Metabolic Bone Diseases
  and Disorders of Mineral Metabolism. 4th edition,
  1999

9
Osteoporotic Fractures in Women Comparison with
Other Diseases

• Riggs BL, Melton LJ. Bone 1995
• Heart and Stroke Facts, 1996, American Heart
  Association
• Cancer Facts Figures, 1996, American Cancer
  Society

10
Projected Burden of Osteoporotic Hip Fractures
Worldwide

• Total no. hip fractures1990 1.66 million2050
  6.26 million

Adapted from Cooper C., Melton LJ, Osteoporos Int
1992, 2285
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OSTEOPOROSIS MORTALITY MORBIDITY
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Hip Fracture vs. Stroke MortalityDeath Rates
per 100,000 in Older Women

• Hip Fracture Stroke
• Sweden 177 154
• Denmark 154 180
• Germany 131 190

Hip fracture data age 80 Kanis JA, J Bone Miner
Res 2002, 171237 Stroke data ages 65-74 Sans
et al., Eur Heart J 1997, 181231
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Relative Risk of Death Following Clinical
FracturesFracture Intervention Trial (FIT)

• 6459 postmenopausal women ages 55-81 years
  followed for an average of 3.8 years

Any Symptomatic
Non-spine
6.7
Hip
8.6
Spine
Forearm
Other
0
1
2
5
16
10
Age-Adjusted Relative Risk (95 CI)
Cauley JA et al., Osteoporos Int 2000, 11556
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Cumulative Survival Probability
MEN
WOMEN
Survival probability
Survival probability
60
65
70
75
80
85
60
65
70
75
80
85
Age
Age

• Center JR et al., Lancet 1999, 353878

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Mortality Rates by Number of Prevalent Vertebral
Fractures
45
40
35
30
25
Mortality (per 1000 person-years)
20
15
10
5
0
5
0
1
2
3
4
Number of Vertebral Fractures

• Kado DM et al., Arch Intern Med 1999,1591215

P for trend lt 0.001
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Clinical Consequences

• Kyphosis
• Loss of height
• Bulging abdomen

• Acute and chronic pain
• Breathing difficulties, reflux and other GI
  symptoms
• Depression

REDUCED QUALITY OF LIFE
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Vertebral Fractures Substantially Increase the
Risk of New Fragility Fractures

• Women with vertebral fractures have a 5-fold
  increased risk of a new vertebral fracture and a
  2-fold increased risk of hip fracture
• Black et al., J Bone Miner Res 1999
• Melton et al, Osteoporos Int 1999
• One woman in five will suffer from another
  vertebral fracture within a year
• Lindsay et al., JAMA, 2001

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Effect of Prior Vertebral Fracture on Risk of
Subsequent Vertebral Fracture
First Year of Study 2725 postmenopausal women
randomised to placebo
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RR7.3 (4.4, 12.3)
RR5.1 (3.1, 8.4)
10
Incidence of New Vertebral Fracture ()
RR2.6 (1.4, 4.9)
5
0
?1
?2
0
1
No. of Vertebral Fractures at Baseline
Adapted from Lindsay R et al., JAMA 2001, 285320
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All Types of Vertebral Fractures are Associated
With Morbidity
93.2
100
Limited Activity
76.2
Bed Rest
75
Due to back pain
52.7
Patients ()
50
36.8
26.9
25
3.9
0
No Incident Fracture
Radiographic Fracture
Clinical Fracture

• Nevitt MC et al., Arch Intern Med.2000, 16077

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Vertebral Fractures in Summary

• Are the most common osteoporotic fractures
• Are associated with excess mortality
• Are associated with significant morbidity, even
  if they do not come to clinical attention
• Increase the risk of subsequent vertebral
  fracture(s) by 5 fold and of other fragility
  fractures (including hip) by 2 fold

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COST OF OSTEOPOROSIS
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Some Costs of Osteoporosis in Europe

• In Europe the total direct costs of osteoporotic
  fractures are over 31 billion and are expected
  to increase to more that 76 billion in 2050.
  Kanis JA Johnell O. - Osteoporos Int 2005 (in
  press)
• In France osteoporotic hip fractures are
  estimated to cost about 1 billion every year
• In Spain the total direct hospital cost of
  osteoporotic fractures in 1995 was approximately
  222 million
• In England Wales the total direct hospital cost
  of osteoporotic fractures in 1999 was
  approximately 847 million

Osteoporosis in the European Community A Call
to Action. IOF Nov, 2001
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Osteoporosis Results in More Disability Direct
Hospital Cost Than Many Other Diseases

• 8 of vertebral fractures are hospitalised and 2
  require long-term nursing care
• Ross et al., Am Journal of Medicine 1997,
  103(2A)30S 42S
• Annual cost of acute hospitalisation in
  Switzerland in 1992 600 million Swiss francs
  (US350 million)
• Lippuner et al., Osteoporosis Int 1997, 7414-25
• Number of bed days (men women)
• 891,000 for COPD
• 701,000 for osteoporosis
• 533,000 for stroke
• 328,000 for myocardial infarction
• 201,000 for breast cancer

Osteoporosis 1 when looking at women only
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UNDER-DIAGNOSIS OF VERTEBRAL FRACTURESWHAT IS
THE SIZE OF THE PROBLEM?
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A Retrospective Study Suggests that Vertebral
Fractures are Under-Diagnosed
132
140
934 hospitalised women with a lateral chest x-ray
120
100
80
65
Patients (n)
60
40
25
23
20
0
Fracture identified by study radiologists
Fracture noted in radiology report
Fracture noted in medical record
Received osteoporosis treatment

• Gehlbach et al.,Osteoporos Int 2000, 11577

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A Large Prospective Study Demonstrates
Under-Diagnosis of Vertebral Fractures is a
Worldwide Problem

• Vertebral fractures were markedly under-diagnosed
  in radiology reports in a multicenter,
  multinational study population of osteoporotic
  women (n2451) in which 789 (32) women had ?1
  vertebral fracture at baseline.
• Adjudicated discrepancies (n350) between local
  and central readings due to undetected vertebral
  fracture (68) or equivocal terminology in the
  local radiology report (32) yielded a
  false-negative rate of 34.
• Under-diagnosis of vertebral fractures was
  observed in all geographic regions
  (false-negative rates North America 45.2, Latin
  America 46.5, Europe/South Africa/Australia
  29.5). The false-positive rate was 5 globally.
• Under-diagnosis of vertebral fracture is a
  worldwide problem attributable in part to a lack
  of radiographic detection or use of ambiguous
  terminology in the radiology report, or both.

Delmas et al., J Bone Miner Res 2005, in press.
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Awareness Treatment of Vertebral Fractures in
Europe is Low Despite

• Known disability associated with all fractures
• Excess mortality associated with vertebral and
  hip fractures
• 31 billion total direct hospital costs in Europe
• A validated radiographic diagnosis technique
• Effective and safe treatments
• Evidence based guidelines for diagnosis and
  management

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Effective therapies are widely available and can
reduce vertebral, hip and other fractures by 30
to 65.
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Antifracture Efficacy of Antiosteoporotic Agents
Incident vertebral fractures - Relative risk
RR 95 CI
RLX 60 (MORE)
RLX 60 (MORE)
ALN 5/10 (FIT1)
ALN 5/10 (FIT2)
RIS 5 (VERT - NA)
RIS 5 (VERT - MN)
CT 200 (PROOF)
Teriparatide 20µg
Strontium ranelate (SOTI)
Strontium ranelate (SOTI TROPOS)
0.2
0.6
1.0
0.8
0.4
with prev vert fracture(s) without prev
vert fractures

• Updated from Delmas, Lancet 2002

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RECOGNITION REPORTING OF VERTEBRAL FRACTURES
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Vertebral FracturesSemi-quantitative reading /
visual scoring

• Genant et al., J Bone Miner Res 1993, 8137

32
SQ Mild FX
SQ Severe FX
3
1
1
3
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Single Energy Fan-beam DXA Imaging a Potential
Alternative to Conventional Radiographs

• Single energy imaging
• Fast (10 sec) scanning / breath hold
• Simple visual evaluation
• Low dose (1/100 of radiographs)
• Available at point of care

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Lateral Vertebral Assessment Point-of-Care
tools
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Combining BMD Vertebral Fracture Assessment A
New Approach to Improve the Diagnosis Rate of
Vertebral Fractures

• Improve risk assessment
• Identify many (30) of missed fractures
• Improve targeting of therapy
• May improve patient understanding, acceptance and
  compliance

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Conclusions

• Most vertebral fractures are a complication of
  osteoporosis and increase the likelihood of
  subsequent fractures
• Currently mild and moderate vertebral fractures
  are often not being recognised and reported,
  leading to under-diagnosis and under-treatment
• Radiographic diagnosis is considered the best way
  to identify and confirm the presence of vertebral
  fractures in clinical practice
• All vertebral fractures identified should be
  reported as FRACTURED to avoid ambiguity caused
  by other terminology
• Early radiographic diagnosis followed by
  appropriate therapy will help prevent subsequent
  fractures
• Effective therapies are widely available and
  can reduce vertebral, hip and other fragility
  fractures by 30 to 65.

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Action is needed by Radiologists to ensure

• Recognition of vertebral fractures using
  radiography imaging techniques
• Reporting as FRACTURED to avoid ambiguity
• These actions will help patients receive
  effective treatment and prevent subsequent
  fractures

This is the goal of the IOF / ESSR Vertebral
Fracture Initiative