Denosumab Safety Assessment in Multiple Observational Databases
Status:
Active, not recruiting
Trial end date:
2024-08-14
Target enrollment:
Participant gender:
Summary
This is a prospective open-cohort study with annual assessment and reporting of descriptive
findings from 5 secondary data sources. The study period will include up to 10 years in each
data system. The secondary data sources will be the following: *US Medicare, including Parts
A, B, and D* United HealthCare* Scandinavian national health registry databases, including
data from Denmark, Sweden, and Norway. Data will be collected for postmenopausal women
overall, women with PMO, and patients who receive Prolia for unapproved indications.
Details
Lead Sponsor:
Amgen
Collaborators:
Aarhus University Hospital OPTUM Insight Optum, Inc. University of Alabama at Birmingham