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Select Bisphosphonates and Select Outcomes of Interest

    Basic Details
    Date Posted
    Medical Product
    Health Outcome(s)
    esophageal cancer
    hip fracture
    non-vertebral fracture
    osteonecrosis of the jaw

    Modular program-based one-time assessment  using the Mini-Sentinel Cohort Identification and Descriptive Analysis (CIDA) Tool to assess alendronate episodes, risedronate episodes, and ibandronate episodes and subsequent events, including fracture of interest, esophageal cancer, hip fracture, non-vertebral fracture, or osteonecrosis of the jaw in the Mini-Sentinel Distributed Database. Please see Appendix A for a list of ICD-9-CM diagnosis codes used for outcomes of interest. Two runs of the CIDA tool were required; click here for more information on CIDA. The time window for this request was January 1, 2006 to December 31, 2013. The package was distributed to three Data Partners in December 2014, and one Data Partner in January 2015; this report contains information from four Data Partners. Please see the Specifications tab for more details on each scenario.

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    Additional Details
    FDA Center
    Time Period
    January 1, 2006 - December 31, 2013
    Analysis Type
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)