Select Bisphosphonates and Select Outcomes of Interest

    Basic Details
    Date Posted
    Saturday, March 14, 2015
    Status
    Complete
    Medical Product
    biphosphonate
    Health Outcome(s)
    esophageal cancer
    fracture
    hip fracture
    non-vertebral fracture
    osteonecrosis of the jaw
    Description

    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.

    If you are using a web page screen reader and are unable to access this document, please contact the Mini-Sentinel Operations Center for assistance by clicking on the Submit Comments link above or sending an email requesting assistance to info@mini-sentinel.org.

    The information contained on this website is provided as part of FDA's commitment to place knowledge acquired from the Mini-Sentinel pilot in the public domain as soon as possible. Please read the disclaimer.

    Additional Details
    FDA Center
    CDER
    Time Period
    January 1, 2006 - December 31, 2013
    Study Type
    Modular Program
    Assessment Type
    Exploratory Analyses
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)