An open label randomized controlled trial on the preemptive risedronate intervention for glucocorticoid-induced osteoporosis in chronic kidney disease patients

UMIN ID: C000000387

Registered date:01/04/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Glucocorticoid-induced osteoporosis in CKD patients
• Date of first enrollment: 2003/08/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Active vitamin D alone (1 year)
Active vitamin D + risedronate (1 year)
Risedronate alone (1 year)

Outcome(s)

• Primary Outcome: Change in bone mineral density at one year interval
• Secondary Outcome: Changes in bone turnover markers, PTH, and indices of renal function. Safety. Compliance

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Patients receiving specific treatments that affect bone and mineral metabolism such as SERM, HRT, calcitonin, recombinant human PTH, and other bisphosphonate, except for active vitamin D. Patients in or expecting pregnancy

Related Information

• Primary Sponsor: Department of Nephrology, Osaka University School of Medicine
• Secondary Sponsor: None
• Source(s) of Monetary Support: Sanofi Aventis,None
• Secondary ID(s): CRG040600074