TabsDetailsBasic DetailsDate Posted: Monday, July 1, 2019Status: In progressMedical Product: Lupron Depot-PEDHealth Outcome(s): fracturehip replacementosteoporotic fracturetemporomandibular joint replacementDescription: 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. Read More Deliverables (1)Sentinel Analytic Package: Osteoporotic Fracture Following Lupron Depot-PED Use: A Multiple Factor Matched AnalysisAdditional InformationAdditional DetailsFDA Center: CDERTime Period: January 1, 2000 - August 31, 2018Study Type: Modular ProgramAssessment Type: Safety AnalysesPopulation / Cohort: Children 0 to 10 years of age at cohort entryData Sources: Sentinel Distributed Database (SDD)Related Links: Lupron Depot-PED Use Among Patients with Central Precocious PubertyOsteoporotic 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"
