Select Bisphosphonates and Select Outcomes of Interest

Project Title Select Bisphosphonates and Select Outcomes of Interest
Date Posted
Saturday, March 14, 2015
Status
Complete
Deliverables
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.

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Medical Product
biphosphonate
Health Outcome
esophageal cancer
fracture
hip fracture
non-vertebral fracture
osteonecrosis of the jaw
Time Period
January 1, 2006 - December 31, 2013
Assessment Type
Exploratory Analyses
Study Type
Modular Program
Data Sources
Mini-Sentinel Distributed Database (MSDD)
FDA Center
CDER
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