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Potential and Pitfalls of Using Large Administrative Claims Data to Study the Safety of Osteoporosis Therapies

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Abstract

Long-term bisphosphonate use may be associated with several rare adverse events. Such associations are not optimally evaluated in conventional randomized controlled trials due to the requirements of large numbers of patients and long-term follow-up. Alternatively, administrative claims data from various sources such as Medicare have been used. Because claims data are collected for billing and reimbursement purposes, they have limitations, including uncertain diagnostic validity and lack of detailed clinical information. Using such data for pharmacoepidemiologic research requires complex methodologies that may be less familiar to many researchers and clinicians. In this review, we discuss the strengths and limitations of using claims data for osteoporosis drug safety research, summarize recent advancements in methodologies that may be used to address the limitations, and present directions for future research using claims data.

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Acknowledgment

This project was supported by grant no. T32HS013852 from the Agency for Healthcare Research and Quality. The content is solely the responsibility of the authors and does not necessarily represent the official views of the Agency for Healthcare Research and Quality.

Disclosure

Drs. Kilgore and Delzell have received grant support from Amgen.

Dr. Saag has served on the board of trustees for the National Osteoporosis Foundation and on the editorial board for the Annals of Internal Medicine. He has also received grant support from Merck & Co., Takeda Pharmaceutical Co., Eli Lilly and Company, and Amgen, and has served as a consultant for, received honoraria from, and had travel/accommodations expenses covered or reimbursed by the following: Merck & Co., Eli Lilly and Company, Novartis, Amgen, Aventis, Pfizer, Genentech, and Horizon Pharma.

Drs. Zhang, Yun, and Wright reported no potential conflicts of interest relevant to this article.

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Authors and Affiliations

  1. Department of Epidemiology and Health Services/Comparative Effectiveness Research Training Program, University of Alabama at Birmingham, 1665 University Boulevard, RPHB 517B, Birmingham, AL, 35294, USA

    Jie Zhang

  2. Department of Epidemiology, University of Alabama at Birmingham, 1665 University Boulevard, RPHB 517D, Birmingham, AL, 35294, USA

    Huifeng Yun

  3. Department of Epidemiology, University of Alabama at Birmingham, 1665 University Boulevard, RPHB 523C, Birmingham, AL, 35294, USA

    Nicole C. Wright

  4. Department of Health Care Organization and Policy, University of Alabama at Birmingham, 1665 University Boulevard, RPHB 330, Birmingham, AL, 35294, USA

    Meredith Kilgore

  5. Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, 510 20th Street South, Faculty Office Tower 820, Birmingham, AL, 35294, USA

    Kenneth G. Saag

  6. Department of Epidemiology, University of Alabama at Birmingham, 1665 University Boulevard, RPHB 517E, Birmingham, AL, 35294, USA

    Elizabeth Delzell

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  1. Jie Zhang
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  2. Huifeng Yun
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  4. Meredith Kilgore
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  5. Kenneth G. Saag
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  6. Elizabeth Delzell
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Correspondence to Jie Zhang.

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Zhang, J., Yun, H., Wright, N.C. et al. Potential and Pitfalls of Using Large Administrative Claims Data to Study the Safety of Osteoporosis Therapies. Curr Rheumatol Rep 13, 273–282 (2011). https://doi.org/10.1007/s11926-011-0168-8

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