| 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 |
