Financial support for the GLOW study is provided by Warner-Chilcott Company, LLC and sanofi-aventis to The Center for Outcomes Research,

University of Massachusetts Medical School.

An Overview of The Global Longitudinal Study of

Osteoporosis in Women (GLOW)

GLOW Overview Slide Set

This material is dedicated to the public domain.

Please cite any use of this material as follows:

Copyright 2010 University of Massachusetts Medical School

Financial support for GLOW is provided byWarner-Chilcott Company, LLC and sanofi-aventis

Under a research contract to The Center for Outcomes Research,

University of Massachusetts Medical School

Goal

To improve our understanding

of the risks for and prevention of

osteoporosis-related fractures

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Specific Aims

Describe the prevalence of risk factors for osteoporosis-related fractures

Assess patterns of diagnosis and treatment of osteoporosis

Document factors that influence patient adherence to treatment

Assess the real-world effectiveness of osteoporosis treatment

Identify geographic differences in these data Assess self-perceived fracture risk and impact

of fracture on quality of life4

Epidemiology of Osteoporosis

Over 200 million people worldwide suffer from osteoporosis¹

Approximately 30% of postmenopausal women in the U.S. and Europe have osteoporosis, of which 40% will sustain one or more fragility fractures in their remaining lifetime²

With aging of the populations, annual osteoporotic fractures worldwide are estimated to triple by the year 2050³

¹Cooper et al. Osteoporos Int. 1992 Nov;2(6):285-9

²Melton et al. J Bone Miner Res 1992;7:1005-10

³Reginster et al. Bone 2006;38:S4-S9

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Design

Prospective, longitudinal, multinational, observational cohort study

Patients sampled through physician practices Representative sample of physician practices

within region Representative sample of non-institutionalized

women aged 55 and older

Data collection by annual mail and phone surveys

2:1 over-sampling of women ≥65 years of age

Physician Practices

Primary care and general practice physicians Were recruited through

– Established primary care physician research networks (Not networks specific to bone research)

– Physician practice associations– From a representative sample of primary care

physicians in each pre-defined study region

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Scope of Letter Survey

Demographic data

Medical history

Risk factors for osteoporosis-related fracture

Fracture history

Self-report of prevention, diagnosis and treatment of osteoporosis

Health and functional status

Health-service access and utilization

Study Sample Frame

Countries 10 Study sites 17 Physicians 723 Women 60,393

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Europe: 8 Regional Centers

Paris

Christian Roux

Lyon

Roland Chapurlat

Essen

Johannes Pfeilschifter

Southampton

Cyrus Cooper

& Juliet Compston

Leuven

Steven Boonen

Amsterdam

J. Coen Netelenbos

Verona

Silvano Adami

Barcelona

Adolfo Díez- Pérez

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United States: 7 Regional Centers

Seattle, WA

Andrea LaCroix

Birmingham, AL

Ken Saag

Pittsburgh, PA

Susan Greenspan

Cincinnati, OH

Nelson Watts

New York, NY

Robert Lindsay & Ethel Siris

Worcester, MA

Stephen Gehlbach

Los Angeles

Stuart Silverman

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Australia and Canada

Sydney

Philip Sambrook

Hamilton, Ontario

Jonathan Adachi

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Survey Domains

Baseline:– Risk perception– Risk factors– Fracture history– Functional status– Quality of life

Follow-up:– Incident fractures– Discontinuation or change in treatment

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Study Subjects

60,393 Women Enrolled

Enrollment phase completed April 1, 2008

From 723 physicians in 17 cities in

10 countries

61% are 65 years of age or older

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First Publication: GLOW Rational and Study Design

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Enrollment by Geographic Region

 Europe USA

Canada/Australia

Total

Sites 8 7 2 17

Physicians 339 298 86 723

Subjects 25,334 28,170 6,889 60,393

Hooven FH et al. Osteoporosis Int 2009;20:1107-16

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Characteristics of Enrolled Women

CharacteristicGLOW Overall

(n=60,393)

GlowU.S.

(n=28,170)

NHANES Women

(2005-06)

Mean age, years 69 69 68

Mean weight, lb 148 159 163

%

Weight<125 lb (57 kg) 16 15 16

Education Level

Less than high school NA 7.4 23

High school NA 26 30

More than high school NA 67 47

Hooven FH et al. Osteoporosis Int 2009;20:1107-16

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Baseline History of Fractures

Hooven FH et al. Osteoporosis Int 2009;20:1107-16

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Frequency of Comorbid Conditions

Hooven FH et al. Osteoporosis Int 2009;20:1107-16

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Fair or Poor General Health (Self-report)

Hooven FH et al. Osteoporosis Int 2009;20:1107-16

Percent

Concern about osteoporosis

Very concerned 25

Somewhat concerned 54

Talked with their doctor about osteoporosis 43

Doctor told subject she had osteoporosis 21

Doctor told subject she had osteopenia 19

Self-rated risk of osteoporosis

Lower 33

Higher 19

Awareness of Osteoporosis

Hooven FH et al. Osteoporosis Int 2009;20:1107-16 21

Limitations of Previous Studies Addressed by GLOW

Inclusion of subjects previously diagnosed with osteoporosis

Ability to compare regional variations using standard survey instruments

Inclusion of the full range of available pharmacological treatments of osteoporosis

Ability to compare fracture rates among treated and untreated women

Ability to assess impact of treatment on fracture incidence in a “real world” setting

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Conclusions

GLOW provides longitudinal and multi-national estimates of risk factors for osteoporosis-related fractures in a large sample of women

Risk factors are common, and show geographic variation

Quality of life data permits robust estimation of costs and benefits for women with different types of fracture, and different risk exposures

GLOW findings can inform initiatives to enhance persistence with drug therapy

Publications

Published manuscripts = 3

Published abstracts = 39

http://www.outcomesumassmed.org/glow/bibliography.cfm

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Scientific Advisory Committee Co-Chairs: Robert Lindsay and Adolfo Díez-Pérez

NetherlandsJ. Coen Netelenbos

SpainAdolfo Díez-Pérez

United KingdomJuliet E. CompstonCyrus Cooper

United StatesStephen H. GehlbachSusan L. GreenspanAndrea Z. LaCroix Robert LindsayKenneth G. SaagStuart L. SilvermanEthel S. SirisNelson B. Watts

AustraliaPhilip N. Sambrook

Belgium Steven Boonen

Canada Jonathan D. Adachi

Germany Johannes Pfeilschifter

FranceRoland D. ChapurlatPierre Delmas (deceased)Christian Roux

ItalySilvano Adami

25Study coordinated by The Center for Outcomes Research,

University of Massachusetts Medical School