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Canadian Multicentre Osteoporosis Study (CaMos)

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10 year prospective population based epidemiologic study. Sample frame: 40% Canadian of population ... Saskatoon. D. Hanley .Calgary. J. Prior .Vancouver ... – PowerPoint PPT presentation

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Title: Canadian Multicentre Osteoporosis Study (CaMos)


1
Canadian Multicentre Osteoporosis Study(CaMos)
2
What is CaMos?
  • 10 year prospective population based
    epidemiologic study
  • Sample frame 40 Canadian of population
  • Random sample 9,423 subjects initial recruitment
  • Recruitment July 1995 to Sept. 1997
  • Women and men ³ 25 years
  • Questionnaire, DXA, US, spine x-ray

3
Investigators
  • David Goltzman Principal Investigator
  • Nancy Kreiger Principal Investigator
    (Epidemiologist)
  • Alan Tenenhouse P.I.Emeritus (P.I., 1993-2004)
  • Brian Lentle Consultant for X-ray QC
  • Bill Leslie Associate Investigator
  • (PI of First Nations Study)
  • Consultant for DXA QC

4
InvestigatorsCentre Directors
  • C. Joyce, C. Kovacs St Johns
  • S. Kirkland, S. Kaiser .. Halifax
  • J. Brown, L. Bessette . Quebec City
  • T. Anastassiades, T. Towheed .... Kingston
  • R. Josse, S. Jamal .. Toronto
  • T. Murray (Emeritus) .. Toronto
  • J. Adachi, A. Papaioannou .. Hamilton
  • W. Olszynski, S. Davison . Saskatoon
  • D. Hanley .. Calgary
  • J. Prior .. Vancouver

5
Support Centres
  • The National Coordinating Centre is located in
    Montreal in the McGill University Health Centre
  • Suzette Poliquin National Coordinator
  • Regional Coordinating Centres are located at each
    of the nine sites
  • The Imaging Centre for DXA and X-ray Analysis is
    in Quebec City at Centre Hospitalier Universite
    Laval
  • Marc Gendreau Chief Coordinator
  • The Data Entry and Analysis Centre is in
    Montreal in the McGill University Health Centre
  • Claudie Berger Chief Statistician
  • The Blood and Urine Collection and Analysis
    Centre is in the McGill University Health Centre
    in Montreal

6
Regional Centres and National Coordinating Centre
(Montreal)
7
Organizational Structure
BOARD Chair Committee chairs Executive External
Members (1)
EXECUTIVE Principal Investigator Chair of the
the Board Chair Centre Director PI
Emeritus National Coordinator
COMMITTEES Centre Directors Finance Design,
Analysis Publications Communication Quality
Control Industry Forum
NATIONAL COORDINATING CENTRE National
coordinator Administrative Secretary
Regional Centres (9) Coordinators Interviewers T
echnologists
Data Entry Centre Research Assistant Data
entry Clerk
Data Analysis Centre Statisticians
Bone Markers Genetics Centre Technician
Imaging Centre Coordinator
Quality Control Centre Coordinator
Ultrasound Data Centre Coordinator
8
Data Acquisition
  • Original Cohort
  • 6539 women, mean age (SD) 63.1 (12.8)
  • 2884 men, mean age (SD) 59.9(14.5)
  • At baseline, a long questionnaire was
    administered and participants underwent bone
    mineral density, height and weight measurement
    and ultrasound testing.
  • Participants aged 50 years and older also had
    thoracic and lumbar spine X-rays taken at
    baseline to assess the prevalence of fractures.
  • Blood and urine samples were obtained at 2
    centres.

9
Data Acquisition (contd)
  • Participants received a follow up short
    questionnaire annually. Self reported fractures
    were confirmed by medical report or hospital
    discharge.
  • Respondents had a long questionnaire repeated
    at three (participants age 40-60), five and ten
    years after the baseline assessment.

10
Data Acquisition (contd)
  • At the five and ten year follow-up, all
    participants underwent a repeat bone mineral
    density test, height and weight measurement,
    ultrasound and spine X-rays (aged ³ 50 years)
  • Blood and urine samples collected in 6 centres
    at year ten follow-up
  • Participant retention was 86 at 5 year

  • gt72 at year 9

11
Data Acquisition (contd)
  • Youth cohort
  • 1 000 participants 16-25 years
  • Both males and females were recruited between
    August 2004 and June 2006 as a Youth Cohort
  • They participated in a long questionnaire and in
    BMD studies
  • Blood and urine samples collected in 5 centres

12
What is unique about CaMos?
  • Random sample of Canadian population
  • Men and women ³ 25 years of age are included
  • Prospective, annual follow-up, 3 (40-60 years
    of age), 5 and 10 year extensive follow-up
  • Imaging (BMD, ultrasound, spine X-rays at
    ³ 50 years of age)
  • Blood and urine samples (including biochemical
    markers), in 6 centres
  • Excellent cohort retention

13
CaMos Objectives
  • Demographics of Osteoporosis
  • Risk Factors
  • Impact of Osteoporosis

14
1. Demographics of Osteoporosis
  • To estimate the prevalence of main fractures
    associated with osteoporosis (hip, wrist and
    vertebra) in Canadian women and men aged ³ 50
    years
  • To estimate the annual incidence of
  • - fractures of the hip and wrist and
  • - fractures of the vertebrae,
  • in women and men aged ³ 50 years.

15
Demographics of osteoporosis (contd)
  • To estimate the distribution of bone mineral
    densities (BMD) as measured by Dual Energy X-Ray
    Absorptiometry (DXA), in women and men aged
    ³ 25 years
  • To estimate the distribution of stiffness (SOS,
    BUA) as measured by Ultrasound of the Calcaneus
    (US), in women and men aged ³ 25
    years
  • To estimate the pattern of change in
    distributions of BMD and US measures over
    time, in women and men aged ³ 25 years

16
Demographics of osteoporosis (contd)
  • To develop a Canadian reference standard for
    age-matched BMD (Z-scores) in females and males
    age 16 to 24
  • To estimate the age of peak bone mass at
    different skeletal sites as measured by DXA in
    women and men.

17
2. Risk Factors
  • To assess the relationship between
    socio-demographic characteristics (e.g. sex, age,
    race, geographic region) or exogenous exposure
    (e.g. hormones and medication, diet, physical
    activity) and occurrence of
  • minimum trauma clinical fractures and
  • morphometric vertebral fractures in
  • women and men aged ³ 50 years

18
Risk Factors (contd)
  • To assess the relationship between certain
    socio-demographic characteristics (e.g. sex,
    age, race, geographic region) and exogenous
    exposures (e.g. exogenous hormones and
    medication, diet, physical activity) and DXA
    and US measurements, in women and men aged ³
    25 years.

19
3. Impact of Osteoporosis
  • To assess the relationship between osteoporosis
    and/or fractures,
  • and health status
  • To examine the burden of illness as a result of
    fracture.

20
Selected Results
  • Demographics of Osteoporosis
  • Risk Factors
  • Impact of Osteoporosis

21
1. Demographic of Osteoporosis
22
A. BMD Changes with Age in Women BMD of the
Lumbar Spine and Femoral Neck in Women 25 Years
and Older
Tenenhouse et al. Osteoporosis Int 200011897-904
23
B. BMD Changes with Age in Men BMD of the
Lumbar Spine and Femoral Neck In Men 25 Years
and Older
Tenenhouse et al. Osteoporosis Int 200011897-904
24
C. Mean PBM in Women and Men CaMos
compared to NHANES
BMD (g/cm2) (SD) BMD (g/cm2) (SD) BMD (g/cm2) (SD) BMD (g/cm2) (SD)
Women Women Men Men
Site CaMos NHANES CaMos NHANES
femoral neck 0.857 0.858 0.910 0.934
femoral neck (0.125) (0.120) (0.125) (0.137)
trochanter 0.700 0.708 0.790 0.778
trochanter (0.088) (0.099) (0.103) (0.118)
CaMos subjects were 25-29 years for the femoral
neck and 25-39 for the trochanter Looker et
al, J Bone Miner Res 1997121761-1768 Tenenhouse
et al. Osteoporosis Int 200011897-904
25
D. Prevalence of Vertebral Deformity
Jackson et al. Osteoporos Int 200011680-687
26
E. What is the Prevalence of Undiagnosed
Osteoporosis (as defined by BMD or prevalent
minimal trauma fractures) ?
27
CaMos Care Gap Analysis
  • Goal
  • To examine the state of the diagnostic care gap
    in Canada over a 5-year period of time using
    CaMos data.
  • Inclusion Criteria
  • All men and women 50 years of age and older at
    baseline.

Papaioannou et al. CaMos Annual Scientific
Meeting 2006
28
CaMos Care Gap Analysis (contd)
  • Fracture Categories
  • All minimal trauma fractures
  • (excluding toes, fingers, skull, face),
    including
  • Vertebral (clinical)
  • Hip
  • Pelvis
  • Rib
  • Wrist
  • Treatments categories
  • Bisphosphonates
  • HRT
  • Raloxifene
  • Calcitonin/Fluoride

29
Diagnostic Care Gap
Difference in Diagnosed with OP (Year 0 to
5) Women 35 Men 20
30
Diagnostic Care Gap (contd)
  • General Conclusions
  • After 5 years in the study, only
  • 55 of women
  • 25 of men
  • with osteoporosis (determined by CaMos DXA)
    were actually diagnosed with OP.
  • At baseline, lt 20 of participants with fragility
    fracture were diagnosed with OP (further analyses
    needed to examine change over time)

31
Summary
  • Osteoporosis is common in Canadians
  • 50 years of age.
  • Most men and women do not know that they have
    osteoporosis by BMD criteria or after a minimal
    trauma fracture.

32
F. What is the Prevalence of Untreated
Osteoporosis (as defined by BMD or prevalent
minimal trauma fractures) ?
33
Therapeutic Care Gap
  • CaMos Participants, 50 years older
  • Baseline Year 5

Papaioannou et al. CaMos Annual Scientific
Meeting 2006
34
of Participants on therapy
Difference in treated (baseline to year 5)
Women 23 Men 9
HRT, Bisphosphonate, Raloxifene or
Calcitonin/Fluoride
35
of Participants on therapy
Difference in treated (baseline to year 5)
Women 29 Men 29
HRT, Bisphosphonate, Raloxifene
,Calcitonin/Fluoride
36
Bisphosphonate Use over 5-years (Women)
of Women with Minimal Trauma Fracture treated
with a Bisphosphonate
Difference in treated (baseline to year 5)
26
37
Bisphosphonate Use over 5-years(Men)
of Men with Minimal Trauma Fracture, treated
with a Bisphosphonate
Difference in treated (baseline to year 5) 9
Papaioannou et al. Osteoporos Int 2007 (accepted)
38
of fractures treated in year 5(Women)
  • Vertebral fractures most commonly treated
  • of all fracture types

39
of fractures treated in year 5(Men)
  • Hip fractures most commonly treated
  • of all fracture types

40
General Conclusions
  • Women
  • Increase in treatment for women
  • approximately 20-30 rise from baseline to year
    5 (for all fracture types)
  • Still room for improvement in women with a
    fragility fracture
  • Year 5
  • 1 in 2 women received any osteoporosis therapy
  • 1 in 3 of women received a bisphosphonate

41
General Conclusions (contd)
  • Men
  • Significant care-gap remains
  • At baseline, lt1 of men with a fragility fracture
  • were being treated
  • This rose to only 10 at Year 5

42
  1. Risk Factors for Osteoporosis

43
A. BMD as a Risk Factor for Fracture
Mean femoral neck BMD in subjects with incident
minimal trauma fracture CaMos years 1,2,3
Men are fracturing at higher BMDs than women
(Tenenhouse CaMos Scientific Meeting 2002.)
44
B. Other Risk Factors for Non-vertebral
Fracture (RR 95CI)
  • Forearm fracture after 50 (3.626 1.876, 7.008)
  • Other minimal trauma fractures (1.957 1.082,
    3.540)
  • SF-36 physical summary score (0.965 0.939,
    0.991)
  • Femoral neck bone density (0.036 0.001, 0.937)
  • Inflammatory bowel disease (2.207 1.091, 4.465)

(Papaioannou et al. Osteoporos Int (2005) 16
568578)
45
C. Other Risk Factors for Clinical Vertebral
Fracture ( RR 95CI)
  • SF-36 physical summary score (0.959 0.924,
    0.996)
  • Femoral neck BMD (0.002 0.00, 0.506)
  • Prevalent vertebral deformity (2.337 0.897,
    6.088)
  • Loss of height (1.075 95 CI 0.970, 1.193)

(Papaioannou et al. Osteoporos Int (2005) 16
568578)
46
D. BMD versus Clinical Risk Factors for Fracture
Impact on Prevalence of Osteoporosis
  • Aims
  • To compare the prevalence of osteoporosis
    requiring treatment using three different
    classification systems
  • BMD T-score -2.5 SD
  • Simplified Clinical Risk Factor System (similar
    to OC system)
  • Comprehensive Clinical Risk Factor System
    (similar to WHO system)

(Richards et al. J Bone Miner Res (2007) 167(2)
228-234
47
Aims (contd)1. Densitometric Method
  • If T-score at the lowest site was -2.5 SD then
    the subject was considered to have osteoporosis
    (and to be a candidate for osteoporosis therapy).

48
Aims (contd)
2. Simplified Risk Factor System
  • Age, sex, BMD (lowest T-score)
  • 10-Year Absolute Risk of Fracture, based on age,
    sex and BMD was applied to each patient
  • if
  • Fragility Fracture after age 40, or
  • Systemic Glucocorticoids gt3 months
  • then
  • 10-Year Absolute Risk of Fracture increased by
    10

49
Aims (contd)3. Comprehensive Risk Factor
System
  • Age, sex, BMD (Femoral Neck)
  • Current Cigarette Smoking
  • Parental History of Fracture (without regard to
    site)
  • Prevalent Fragility Fracture after 50 years
  • Ever use of Systemic Corticosteroids
  • Alcohol Intake Greater than 2 units/day
  • BMD lt20 kg/m2
  • Rheumatoid Arthritis

50
Risk Factor Assumptions
  • For both Risk Factor-Based Systems, subjects were
    assessed if their 10-year absolute risk was 15,
    20, or 25
  • All Classification Systems were Age-Adjusted to
    the General Canadian Population

51
The Prevalence of Osteoporosis in Women 50
Years, as Defined by Different Criteria
52
The Prevalence of Osteoporosis in Men 50
Years, as Defined by Different Criteria
53
Prevalence By Age-Groupwith 20 10-Year Fracture
Risk,Age-Adjusted to the CDN Population
Men
Women
Age (years)
54
Prevalence By Age-Groupwith 25 10-Year Fracture
Risk, Age-Adjusted to the Canadian Population
Women
Men
Age (years)
55
Conclusions
  • The application of risk factor-based systems
    results in an increased prevalence of the
    diagnosis of osteoporosis in older women.
  • The prevalence of individuals with osteoporosis
    at high risk for fracture may increase with
    changes to the methods used to determine those
    who are at risk and with the level of risk
    considered high.
  • These data have important implications for the
    pattern of care and costs of treating
    osteoporotic fractures.

56
The Effect of Selective Serotonin Reuptake
Inhibitors on Fracturesand Bone Mineral Density
Objective Examine the effect of daily SSRI use on
the risk of incident clinical fragility fracture
(Richards et al. Arh Intern Med (2007) 188-194
57
Effects of SSRIs (contd)
  • Results
  • In 137 subjects using SSRIs daily
  • Increased risk of incident clinical vertebral
    fracture HR 2.1 (95 CI 1.3-3.4)
  • In addition
  • Increased odds of falling or 2.2 (95 CI
    1.4-3.5)
  • Lower BMD at the hip, and a trend towards lower
    BMD in the spine

58
Effects of SSRIs (contd)
Conclusion Daily SSRI use in adults over 50 years
associated with a 2-fold increased risk of
clinical fragility fracture after adjustment for
potential covariates
59
3. Impact of Osteoporosis
60
What is the Influence of Osteoporotic
Fractureson Health Related Quality of Life
(HRQoL)in Community Dwelling Men and
WomenAcross Canada?
Adachi et al. Osteoporos Int 200112903908 Adach
i et al. Osteoporos Int 200314895904
61
Fractures and HRQL SF-36
Adachi et al. Osteoporos Int 200112903908
62
Fractures and HRQL SF-36 (contd)
Adachi et al. Osteoporos Int 200112903908
63
Fractures and HRQL - HUI
Adachi et al. Osteoporos Int (2003) 14 895904
64
Fractures and HRQL - HUI (contd)
Adachi et al. Osteoporos Int (2003) 14 895904
65
Fractures and HRQL - HUI (contd)
Adachi et al. Osteoporos Int (2003) 14 895904
66
CaMos HUI3 Scores Baseline differences between
diseases
Sawka et al. Osteoporos Int 200516 18361840
67
Conclusions
  • Fractures have a negative impact on SF-36 quality
    of life, particularly on role-physical and
    physical functioning.
  • Fractures have the most negative impact on HUI
    measured ambulation, pain, and mobility.

68
Selected Ongoing Projects
1. Demographics
  • To determine the geographic variation and age and
    sex specific cross-sectional distribution of bone
    mineral density in Canadian adults
  • To determine the rates of change of BMD at
    several skeletal sites (lumbar spine (L14)),
    femoral neck, total hip, trochanter and wards
    triangle) in Canadian women and men 25 years
    from the CaMos cohort.

69
Selected Ongoing Projects (contd)
2. Risk Factors
  • A Comparison of Prevalent Morphometric Vertebral
    Deformity versus Other Risk Factors as
    Predictors of Fracture Risk in women and men
  • Depression as a Risk Factor for BMD and Fracture
  • Beta-blockers, Bone Mineral Density and Fractures
  • Physical Activity relationships with Bone Mineral
    Density and Fracture

70
3. Impact of Osteoporosis
Selected Ongoing Projects (contd)
  • Predictors of mortality in CaMos participants
    with baseline fracture
  • Association between quality of life and incident
    osteoporotic fractures

71
4. Interventions in Osteoporosis
Selected Ongoing Projects (contd)
  • Effect of anti-resorptives on incident
    osteoporotic fractures
  • Prevalence and correlates of complementary and
    alternative medicine use in osteoporosis

72
Summary
  • Large cohort
  • Women men
  • Broad age range
  • Excellent retention
  • 10 year follow-up
  • Large database
  • Osteoporosis fracture
  • Other medical demographic

73
Summary (Cont)
  • Imaging, repeated over 10 years
  • DXA
  • Spine x-rays
  • Bone ultrasound
  • Archived tissue samples
  • Serum
  • Urine
  • DNA
  • National international collaborations
  • Excellent productivity in advancing knowledge re
    osteoporosis
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