Regulation of Bone Formation in Renal Osteodystrophy

Phase 2

Completed

• Conditions: Secondary Hyperparathyroidism; Renal Osteodystrophy
• Interventions: Drug: 1,25 dihydroxy vitamin D3; Drug: 1 alpha D2; Drug: Sevelamer HCl; Drug: Calcium Carbonate

• Registration Number: NCT00560300
• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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 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.

Study Timeline

• Study Start: 2000-11
• Study Completion: 2006-11
• Study First Submitted: 2007-11-13
• Study First Submitted QC: 2007-11-16
• Study First Posted: 2007-11-19
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-12
• Last Update Posted: 2010-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• Stable end-stage kidney disease treated with continuous cycling peritoneal dialysis,
• Biochemical evidence of secondary hyperparathyroidism (PTH>400 pg/ml) with bone biopsy evidence of high turnover bone disease

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Exclusion Criteria

• History of parathyroidectomy
• Growth hormone
• Prednisone, or other immunosuppressant medication within the past year.
• Recent history of medication non-compliance.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
2	Sevelamer HCl	Doxercalciferol + Sevelamer
3	1,25 dihydroxy vitamin D3	Calcitriol + Calcium Carbonate
1	1 alpha D2	Doxercalciferol + Calcium Carbonate
2	1 alpha D2	Doxercalciferol + Sevelamer
4	1,25 dihydroxy vitamin D3	Calcitriol + Sevelamer
4	Sevelamer HCl	Calcitriol + Sevelamer
3	Calcium Carbonate	Calcitriol + Calcium Carbonate
1	Calcium Carbonate	Doxercalciferol + Calcium Carbonate

Primary Outcome Measures

Name	Time	Method
Bone Formation Rate	8 months

Secondary Outcome Measures

Name	Time	Method
Bone histomorphometric parameters other than bone formation rate, biochemical parameters (phosphorus, calcium, PTH, alkaline phosphatase, FGF-23, vitamin D dose)	8 months