Clinical Trial: Regulation of Bone Formation in Renal Osteodystrophy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Regulation of Bone Formation in Renal Osteodystrophy

Brief Summary: To examine the effects of two types of active vitamin D (calcitriol and doxercalciferol) and two phosphate binders (sevelamer and calcium carbonate) on the bone disease and blood tests of children with kidney failure

Detailed Summary: Pediatric patients treated with CCPD who displayed biochemical and bone biopsy proven secondary hyperparathyroidism were randomly assigned to one of 2 vitamin D analogues (calcitriol or doxercalciferol) and one of two phosphate binders (sevelamer or calcium carbonate) in a two by two factorial designed prospective trial. Serum biochemical measurements were obtained at baseline and monthly throughout the 8 months of the trial. Bone biopsy was obtaine at baseline and repeated at study completion.
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Current Primary Outcome: Bone Formation Rate [ Time Frame: 8 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Bone histomorphometric parameters other than bone formation rate, biochemical parameters (phosphorus, calcium, PTH, alkaline phosphatase, FGF-23, vitamin D dose) [ Time Frame: 8 months ]

Original Secondary Outcome: Same as current

Information By: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Dates:
Date Received: November 13, 2007
Date Started: November 2000
Date Completion:
Last Updated: January 12, 2010
Last Verified: January 2010