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

Project Title Osteoporotic Fractures following Lupron Depot-PED Use: A Multiple Factor Matched Analysis
Date Posted
Tuesday, July 2, 2019
Project ID
cder_mpl2p_wp011
Status
In progress
Deliverables
Related Links
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.

Medical Product
Lupron Depot-PED
Health Outcome
fracture
hip replacement
osteoporotic fracture
temporomandibular joint replacement
Population / Cohort
Children 0-10 years of age at cohort entry
Time Period
January 1, 2000 - August 31, 2018
Assessment Type
Safety Analyses
Study Type
Modular Program
Data Sources
Sentinel Distributed Database (SDD)
FDA Center
CDER