Effect of Romosozumab vs. Denosumab on Coronary Atherosclerotic Damage in Postmenopausal Osteoporotic Women: A Phase IV, Low-Risk, Pharmacological Intervention Study. ATRIO Study.
Coronary atherosclerotic status in women with postmenopausal osteoporosis
Investigational medicinal product(s)
EVENITY 105 mg solution for injection in pre-filled penEVENITY 105 mg solution for injection in pre-filled penProlia 60 mg solution for injection in pre-filled syringeEVENITY 105 mg solution for injection in pre-filled penProlia 60 mg solution for injection in pre-filled syringeEVENITY 105 mg solution for injection in pre-filled penProlia 60 mg solution for injection in pre-filled syringeProlia 60 mg solution for injection in pre-filled syringeEVENITY 105 mg solution for injection in pre-filled penProlia 60 mg solution for injection in pre-filled syringeProlia 60 mg solution for injection in pre-filled syringeProlia 60 mg solution for injection in pre-filled syringeProlia 60 mg solution for injection in pre-filled syringeEVENITY 105 mg solution for injection in pre-filled penEVENITY 105 mg solution for injection in pre-filled penProlia 60 mg solution for injection in pre-filled syringeEVENITY 105 mg solution for injection in pre-filled pen
Eligibility
Age group
18-64 years, 65+ years
Sex
Female
Primary endpoint
Difference in coronary CT score according to the CCTA-Leaman method after 12 months of therapy (at V3 compared V1) with Romosozumab and Denosumab.
Endpoint detail
Change in scores: Segment Involvement Score (SIS) and Segment Stenosis Score (SSS) between V1 and V3, Measurement of biomarkers at V1 and their correlation with changes in coronary scores: Sclerostin, Lipoprotein-Associated Phospholipase A2, Myeloid-Related Protein 8 and 14, and Monocyte Chemoattractant Protein 1 (MCP-1)., Difference between CCTA-Leaman SIS, SSS between the two groups at V3
Official registry record
This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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