This analysis investigated whether children with centralized precocious puberty (CPP) who are exposed to leuprolide acetate are at higher risk for fractures compared to children who are unexposed to leuprolide acetate in the Sentinel Distributed Database (SDD).
The primary outcome assessed in this analysis is major fractures. The secondary outcomes are any fracture, hip replacement, and temporomandibular joint replacement. The request contains eight reports.
- Reports 1-4 contain data from January 1, 2000 to August 31, 2018 from 16 Data Partners contributing to the SDD. This request was distributed to Data Partners on April 22, 2019.
- Reports 5-8 contain data from January 1, 2000 to August 31, 2018. This request was distributed to Data Partners on April 27, 2021. Reports 5 and 6 contain data from 12 Data Partners contributing to the SDD. Reports 7 and 8 contain data from 11 Data Partners contributing to the SDD.
Reports 5-8 addressed an error in the calculation of the Kaplan Meier curves initially created in reports 1-4. Additionally, the contributing Data Partners in reports 5-8 were updated to support ease of comparison with a follow-up analysis.
The analytic package associated with this analysis can be found externally in Sentinel's Git Repository located here. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation.