Osteoporotic Fractures Following Lupron Depot-PED Use: A Multiple Factor Matched Analysis

Basic Details
Date Posted
Monday, July 1, 2019
Status
In progress
Medical Product
Lupron Depot-PED
Health Outcome(s)
fracture
hip replacement
osteoporotic fracture
temporomandibular joint replacement
Description

This analysis investigates whether children with centralized precocious puberty (CPP) who are exposed to Lupron Depot-PED are at higher risk for fractures compared to children who are unexposed to Lupron Depot-PED in the Sentinel Distributed Database.

The primary outcome assessed in this analysis is osteoporotic fractures. The secondary outcomes are any fracture, hip replacement, and temporomandibular joint replacement.

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 (1)
Sentinel Analytic Package: Osteoporotic Fracture Following Lupron Depot-PED Use: A Multiple Factor Matched Analysis
Additional Details
FDA Center
CDER
Time Period
January 1, 2000 - August 31, 2018
Study Type
Modular Program
Assessment Type
Safety Analyses
Population / Cohort
Children 10 years of age at cohort entry and younger
Data Sources
Sentinel Distributed Database (SDD)
Related Links
Lupron Depot-PED Use Among Patients with Central Precocious Puberty
Osteoporotic Fracture Algorithm Defined in "Osteoporotic Fractures Following Lupron Depot-PED Use: A Multiple Factor Matched Analysis"
Fracture Algorithm Defined in "Osteoporotic Fractures Following Lupron Depot-PED Use: A Multiple Factor Matched Analysis"
Hip Replacement Algorithm Defined in "Osteoporotic Fractures Following Lupron Depot-PED Use: A Multiple Factor Matched Analysis"
Temporomandibular Joint Replacement Algorithm Defined in "Osteoporotic Fractures Following Lupron Depot-PED Use: A Multiple Factor Matched Analysis"
Sentinel Drug Assessment: Lupron Depot-PED (Leuprolide Acetate) & Any Fracture (Secondary), Hip Replacement (Secondary), Osteoporotic Fracture, and Temporomandibular Joint Replacement (Secondary)
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