Design and methods of a postmarketing pharmacoepidemiology study assessing long-term safety of Prolia® (denosumab) for the treatment of postmenopausal osteoporosis.
Bottom Line: Nine adverse events (AEs) will be assessed based on diagnosis codes: osteonecrosis of the jaw (ONJ), atypical femoral fracture (AFF), fracture healing complications, hypocalcemia, infection, dermatologic AEs, acute pancreatitis, hypersensitivity, and new primary malignancy.This study is based on comprehensive preliminary research and considers methodological challenges specific to the study population.The integrated data systems used in this regulatory committed program can serve as a powerful data resource to assess diverse and rare AEs over time.
Affiliation: Center for Observational Research, Amgen Inc., Thousand Oaks, CA, USA.Show MeSH
Related in: MedlinePlus
Mentions: Time at risk for specific AEs within exposure cohorts will be defined based on putative relationships between Prolia® and/or bisphosphonate exposure and specific AEs. Time at risk will be defined as the on-treatment period for some AEs and as the on-treatment plus post-treatment period for other AEs. Post-treatment period lengths are based on an etiologically relevant period for the specific exposure and AE. Figure 1 shows an example of classification of time at risk for a patient receiving one bisphosphonate dose before one Prolia® dose.
Affiliation: Center for Observational Research, Amgen Inc., Thousand Oaks, CA, USA.