Efficacy of coronary artery calcification on Denosumab

JRCT ID: jRCT1031190025

Registered date:20/05/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Patients with osteoporosis with coronary artery calcification
• Date of first enrollment: 12/12/2019
• Target sample size: 108
• Study type: Interventional

Intervention(s)

Denosumab group
60mg once every 6 months, subcutaneously.
Arendronate sodium hydrate group
35mg orally once a week with approximately 180mL of water at the time of getting up in the morning.

Outcome(s)

• Primary Outcome: Percent change in coronary artery calcification score at 48 weeks after intervention

Secondary Outcome

Degree of improvement of bone density by DXA at 48 weeks after intervention
Percent change in coronary volume score at 48 weeks after intervention

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients (>20 years old) with osteoporosis with coronary artery calcification
• Exclude criteria: Patients who can not enforce coronary artery CT, patients with baseline coronary calcification score of 0 or 1000 or more, secondary osteoporosis patients, patients with severe renal impairment(eGFR<35mL/min).

Related Information

• Primary Sponsor: Kubota Naoki