I am excited to announce the launch of a new network study: CORDIS (Cardiovascular Outcomes in Romosozumab versus Denosumab - an International observational Study).
Primary Purpose
Comparison of cardiovascular outcomes risk of romosozumab vs denosumab
Abstract
The ARCH study (Active-Controlled Fracture Study in Postmenopausal Women With Osteoporosis at High Risk) found that while romosozumab showed superior efficacy in preventing fractures compared to alendronate, it also demonstrated a higher incidence of cardiac ischemic events and cerebrovascular events during the first year. Although romosozumab’s benefits for bone health are clear, several studies suggest potential worsening of cardiovascular disease endpoints.
Our study aims to compare romosozumab with denosumab, another anti-osteoporosis medication, to determine the association between romosozumab and cardiovascular outcomes in a real-world setting.
Study Design
We will conduct a retrospective, observational, multinational cohort study comparing the short-term risk of cardiovascular outcomes between romosozumab and denosumab. The study will utilize administrative claims or electronic health record (EHR) data across the OHDSI network.
Key Information
- Primary Outcomes: Cardiovascular event
- Secondary Outcomes: Acute myocardial infarction, Heart failure, Ischemic stroke, Non-coronary revascularization, Peripheral artery disease, Sudden cardiac death
- Data Analysis: Cox proportional hazards model after propensity score adjustment
The preliminary package for this study is now available, along with a draft of the study protocol.
We are actively seeking collaborators to join this important network study. If you have any questions, comments, or suggestions, please don’t hesitate to reach out.
Thank you for your consideration. We look forward to your participation in this crucial research endeavor.
Sincerely,
Chan