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 by Warner-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 3

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 life 4

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 Nov;2(6):285-9 ²Melton et al. J Bone Miner Res 1992;7: ³Reginster et al. Bone 2006;38:S4-S9 5

6 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 7

8 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  Countries10  Study sites17  Physicians723  Women60,393 9

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 10

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 11

Australia and Canada Sydney Philip Sambrook Hamilton, Ontario Jonathan Adachi 12

Survey Domains  Baseline: –Risk perception –Risk factors –Fracture history –Functional status –Quality of life  Follow-up: –Incident fractures –Discontinuation or change in treatment 13

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 14

First Publication: GLOW Rational and Study Design 15

16 Enrollment by Geographic Region EuropeUSA Canada/ Australia Total Sites87217 Physicians Subjects25,33428,1706,88960,393 Hooven FH et al. Osteoporosis Int 2009;20:

17 Characteristics of Enrolled Women Characteristic GLOW Overall (n=60,393) Glow U.S. (n=28,170) NHANES Women ( ) Mean age, years69 68 Mean weight, lb % Weight<125 lb (57 kg) Education Level Less than high schoolNA7.423 High schoolNA2630 More than high schoolNA6747 Hooven FH et al. Osteoporosis Int 2009;20:

18 Baseline History of Fractures Hooven FH et al. Osteoporosis Int 2009;20:

19 Frequency of Comorbid Conditions Hooven FH et al. Osteoporosis Int 2009;20:

20 Fair or Poor General Health (Self-report) Hooven FH et al. Osteoporosis Int 2009;20:

Percent Concern about osteoporosis Very concerned25 Somewhat concerned54 Talked with their doctor about osteoporosis43 Doctor told subject she had osteoporosis21 Doctor told subject she had osteopenia19 Self-rated risk of osteoporosis Lower33 Higher19 Awareness of Osteoporosis Hooven FH et al. Osteoporosis Int 2009;20:

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 22

23 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 =

Scientific Advisory Committee Co-Chairs: Robert Lindsay and Adolfo Díez-Pérez Netherlands J. Coen Netelenbos Spain Adolfo Díez-Pérez United Kingdom Juliet E. Compston Cyrus Cooper United States Stephen H. Gehlbach Susan L. Greenspan Andrea Z. LaCroix Robert Lindsay Kenneth G. Saag Stuart L. Silverman Ethel S. Siris Nelson B. Watts Australia Philip N. Sambrook Belgium Steven Boonen Canada Jonathan D. Adachi Germany Johannes Pfeilschifter France Roland D. Chapurlat Pierre Delmas (deceased) Christian Roux Italy Silvano Adami 25 Study coordinated by The Center for Outcomes Research, University of Massachusetts Medical School