An open label randomized controlled trial on the preemptive risedronate intervention for renal transplant patients receiving glucocorticoid

UMIN ID: C000000391

Registered date:01/04/2006

Basic Information

• Health condition(s) or Problem(s) studied: Bone disease in renal transplant patients receiving glucocorticoid
• Date of first enrollment: 2003/11/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Active vitamin D alone (2 year)
Active vitamin D + risedronate (2 year)

Outcome(s)

• Primary Outcome: Change in bone mineral density and bone turnover markers at two-year interval
• Secondary Outcome: Ca, iP, PTH, and indices of renal function. Safety.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. Previous history of bisphosphonate treatment and/or hormone replacement therapy within one year before entry 2. Contraindication for risedronate or active vitamin D 3. Not suitable to the clinical trial as judged by a physician

Related Information

• Primary Sponsor: Department of Advanced Technology for Transplantation, Osaka University School of Medicine
• Source(s) of Monetary Support: None
• Secondary ID(s): CRG040600075