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Fractures Following Leuprolide Acetate Use: A Multiple Factor Matched Analysis (A Follow-up to a Previous 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 (served as controls) in the Sentinel Distributed Database (SDD).

This is a follow-up analysis to evaluate the impact of alternative analytic strategies, including fixed ratio matching and multiple factor-stratified analysis, on the distribution of follow-up time and fracture incidence among children exposed to leuprolide acetate and their controls. Compared to the original study that allowed for matched sets of varying sizes, this analysis incorporates two different analytic designs: 1) conditioning the analysis on matched sets of equal sizes, and 2) conditioning on the matching factors themselves. This analysis contains four reports: 

  • Report 1: This report contains results of the main analysis for female patients.
  • Report 2: This report contains results of the main analysis for male patients.
  • Report 3: This report contains results of the sensitivity analysis for female patients, which includes additional censoring criteria.
  • Report 4: This report contains results of the sensitivity analysis for male patients, which includes additional censoring criteria.

These reports contain data from January 1, 2000 to August 31, 2018 from 13 Data Partners contributing to the SDD. This request was distributed to Data Partners on June 17, 2021.

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 (5)
Sentinel Analytic Package: Fractures Following Leuprolide Acetate Use: A Multiple Factor Matched Analysis (A Follow-up to a Previous Analysis) Sentinel Modular Program Report: Fractures Following Leuprolide Acetate Use: A Multiple Factor Matched Analysis (A Follow-up to a Previous Analysis), Report 1 Sentinel Modular Program Report: Fractures Following Leuprolide Acetate Use: A Multiple Factor Matched Analysis (A Follow-up to a Previous Analysis), Report 2 Sentinel Modular Program Report: Fractures Following Leuprolide Acetate Use: A Multiple Factor Matched Analysis (A Follow-up to a Previous Analysis), Report 3 Sentinel Modular Program Report: Fractures Following Leuprolide Acetate Use: A Multiple Factor Matched Analysis (A Follow-up to a Previous Analysis), Report 4
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
Major Fracture Algorithm Defined in "Fractures Following Leuprolide Acetate Use: A Multiple Factor Matched Analysis (A Follow-up to a Previous Analysis)"
Any Fracture Algorithm Defined in "Fractures Following Leuprolide Acetate Use: A Multiple Factor Matched Analysis (A Follow-up to a Previous Analysis)"
Hip Replacement Algorithm Defined in "Fractures Following Leuprolide Acetate Use: A Multiple Factor Matched Analysis (A Follow-up to a Previous Analysis)"
Temporomandibular Joint Replacement Algorithm Defined in "Fractures Following Leuprolide Acetate Use: A Multiple Factor Matched Analysis (A Follow-up to a Previous Analysis)"
Fractures Following Leuprolide Acetate Use: A Multiple Factor Matched Analysis