NCT00560300

Regulation of Bone Formation in Renal Osteodystrophy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 2 Years – 21 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Secondary Hyperparathyroidism
• Renal Osteodystrophy

Interventions

Type	Name	Description
DRUG	1 alpha D2	Vitamin D sterol
DRUG	1,25 dihydroxy vitamin D3	Active vitamin D sterol
DRUG	Sevelamer HCl	Phosphate binder
DRUG	Calcium Carbonate	Phosphate binder

Timeline

• Start date: 2000-11-01
• Completion: 2006-11-01
• First posted: 2007-11-19
• Last updated: 2010-01-14