An Open-label controlled Trial to Assess the Efficacy of Bisphosphonate in the Treatment of Coronary Artery Calcification in Nondialyzed Patients with Diabetic Nephropathy.

UMIN ID: C000000250

Registered date:17/02/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Type 2 diabetic nephropathy
• Date of first enrollment: 2005/09/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Oral administration of etidronate
No drug that affects coronary artery calcification

Outcome(s)

• Primary Outcome: Changes in CACS after 1-year study period.
• Secondary Outcome: Change in ultrasonographical intima media thickness (IMT) of the carotid artery, brachial ankle pulse wave velocity (baPWV), bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA), and serum concentration of bone turnover markers.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Patients with atrial fibrillation, those who are contraindicated for beta-blockers, pregnant patients, or patients planning pregnancy are excluded.

Related Information

• Primary Sponsor: Department of Nephrology, Osaka University School of Medicine
• Secondary Sponsor: Department of Internal Medicine and Therapeutics, Osaka University School of Medicine
• Source(s) of Monetary Support: none