Abstract
Summary
Failure to take prescribed medication is common. The POSSIBLE US™ study is evaluating the impact of physician and patient characteristics on patient-reported compliance and persistence with osteoporosis medications. We report our study design and the baseline characteristics of 4,994 postmenopausal women recruited from primary care physician offices in 33 states.
Introduction
The Prospective Observational Scientific Study Investigating Bone Loss Experience (POSSIBLE US™) is a longitudinal cohort study of osteoporosis therapy in primary care.
Methods
Between 2004 and 2007, 134 physicians (in 33 states) enrolled postmenopausal women initiating, changing, or continuing osteoporosis medications. After completing a baseline questionnaire, participants will provide data semi-annually for up to 3 years through 2008. Physicians provide patient data at baseline and routine follow-up visits. Participants from 23 sites also signed a release regarding administrative claims data for economic analyses and validation of self-reported data.
Baseline results
Four thousand nine hundred and ninety-four evaluable women were recruited from internal medicine (n = 1,784), family practice (n = 1,556), obstetrics/gynecology (n = 1,556), and from one rheumatology practice (n = 98). Mean participant age was 64.3 years (SD = 9.97); 89% were Caucasian; 59% had some college education. Sixty-three percent used a single osteoporosis agent, usually a bisphosphonate. For monotherapy patients, concordance between clinic- and patient-reported medication use was lowest for patients prescribed estrogen therapy (70%) or calcium/vitamin D (72%). Obstetrician/gynecologists enrolled younger women, who were more likely to use estrogen therapy than patients enrolled by other physicians. The 934 women (19%) prescribed only calcium/vitamin D were younger than women prescribed pharmacologic therapy.
Conclusions
POSSIBLE US™ provides a unique foundation for evaluating longitudinal use of osteoporosis medications and related outcomes.
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Acknowledgements
The authors would like to acknowledge the other members of the POSSIBLE US™ Steering Committee: Robert Downs, Ted Ganiats, Marc Hochberg, Barbara Lukert, Robert Recker, Robert Rubin, and Celine Vachon. In addition, we are grateful for the methodologic and data analysis contributions of Marc Alexander, Mike Gao, Aalok Nadkar, Devendra Upendra, and Claudine Woo-Shinoff. We would also like to acknowledge the REGISTRAT, Inc. staff, who assisted with the implementation of this study and ongoing data collection. Funding for this study was provided by Amgen, Inc.
Conflicts of interest
Dr. Barrett-Connor receives support from Amgen, Inc. for serving as Chair of the POSSIBLE US™ Study Steering Committee; she is an investigator on clinical trials for Amgen, Inc., Wyeth, Roche, Ely Lilly, and Merck for whom she also provides consulting services. Dr. Tosteson is a consultant to Amgen, Inc. and to Procter and Gamble.
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Barrett-Connor, E., Ensrud, K., Tosteson, A.N.A. et al. Design of the POSSIBLE US™ Study: postmenopausal women’s compliance and persistence with osteoporosis medications. Osteoporos Int 20, 463–472 (2009). https://doi.org/10.1007/s00198-008-0674-3
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DOI: https://doi.org/10.1007/s00198-008-0674-3