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Fractures Following Leuprolide Acetate Use: A Multiple Factor Matched Analysis

Basic Details
Date Posted
Status
Complete
Medical Product
leuprolide acetate
Health Outcome(s)
any fracture
hip replacement
major fracture (primary)
temporomandibular joint replacement
Description

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.

Deliverables (9)
Sentinel Analytic Package: Fractures Following Leuprolide Acetate Use: A Multiple Factor Matched Analysis Sentinel Modular Program Report: Fractures Following Leuprolide Acetate Use: A Multiple Factor Matched Analysis, Report 1 Sentinel Modular Program Report: Fractures Following Leuprolide Acetate Use: A Multiple Factor Matched Analysis, Report 2 Sentinel Modular Program Report: Fractures Following Leuprolide Acetate Use: A Multiple Factor Matched Analysis, Report 3 Sentinel Modular Program Report: Fractures Following Leuprolide Acetate Use: A Multiple Factor Matched Analysis, Report 4 Sentinel Modular Program Report: Fractures Following Leuprolide Acetate Use: A Multiple Factor Matched Analysis, Report 5 Sentinel Modular Program Report: Fractures Following Leuprolide Acetate Use: A Multiple Factor Matched Analysis, Report 6 Sentinel Modular Program Report: Fractures Following Leuprolide Acetate Use: A Multiple Factor Matched Analysis, Report 7 Sentinel Modular Program Report: Fractures Following Leuprolide Acetate Use: A Multiple Factor Matched Analysis, Report 8
Additional Details
FDA Center
CDER
Time Period
January 1, 2000 - August 31, 2018
Analysis Type
Retrospective Inferential
Population / Cohort
Individuals 10 years of age and younger
Data Sources
Sentinel Distributed Database (SDD)
Related Links
Sentinel Drug Study: Leuprolide Acetate & Major Fracture, Any Fracture, Hip Replacement, and Temporomandibular Joint Replacement
Fractures Following Leuprolide Acetate Use: A Multiple Factor Matched Analysis (A Follow-up to a Previous Analysis)
Major Fracture Algorithm Defined in "Fractures Following Leuprolide Acetate Use: A Multiple Factor Matched Analysis"
Fracture Algorithm Defined in "Fractures Following Leuprolide Acetate Use: A Multiple Factor Matched Analysis"
Hip Replacement Algorithm Defined in "Fractures Following Leuprolide Acetate Use: A Multiple Factor Matched Analysis"
Temporomandibular Joint Replacement Algorithm Defined in "Fractures Following Leuprolide Acetate Use: A Multiple Factor Matched Analysis"