Bisphosphonate Use and the Risk of Adverse Jaw Outcomes: A medical claims study of 714,217 people
Section snippets
MATERIALS, SUBJECTS AND METHODS
The basis of this study is a medical claims database from a large national health insurance plan that provides health coverage to approximately 15 million members. The first step was to extract all medical claims data from April 2000 through April 2006 across the United States for people who had claims for International Classification of Diseases, ninth revision (ICD-9), codes for osteoporosis or cancer. For osteoporosis, the specific codes we included were ICD-9 codes 7330 (osteoporosis),
RESULTS
We analyzed medical claims from a large national health insurance plan to detect signals of risk associated with the use of a widely used class of medications, BPs. The two populations we chose to study were patients with osteoporosis, for whom orally administered BPs were indicated, and patients with certain cancers, for whom high-dose IV BPs were indicated. While low-dose IV zoledronic acid recently was approved for the management of osteoporosis, patients with cancer tend to receive doses
DISCUSSION
The limitations of claims-based analyses are many and often preclude any firm conclusions. Some of the limitations of claims-based analyses are related to the fact that the primary role of the claims database is administrative (billing and operations) and that, thus, it has not been designed for medical research. In comparison with the medical record, medical claims do not contain as many details and, at times, are prone to error. As with all observational studies, medical claims studies often
CONCLUSION
IV, but not oral, BPs seem to be strongly associated with adverse outcomes in the jaws. The increased risks reported here may reflect an increased risk of experiencing ONJ among users of IV BPs. The fact that we were able to replicate a previous study, and the fact that there is internal consistency in both referent conditions (osteoporosis and cancer), raise our confidence about the results and the conclusions of our study. However, carefully controlled clinical studies are required to
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Cited by (0)
This research was partially supported by National Institute of Dental and Craniofacial Research grant 1 R21 DE018143-01.
- 1
Dr. Cartsos is an assistant professor, Department of Orthodontics, School of Dental Medicine, Tufts University, Boston.
- 2
Dr. Zhu is a medical analyst, Ingenix—i3 Drug Safety, Basking Ridge, N.J.
- 3
Dr. Zavras is an associate professor and the director of dental public health, Department of Oral Health Policy and Epidemiology, Harvard School of Dental Medicine, 188 Longwood Ave., REB217, Boston, Mass. 02115, e-mail “[email protected]”. Address reprint requests to Dr. Zavras.