Regulation of Bone Formation in Renal Osteodystrophy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Regulation of Bone Formation in Renal Osteodystrophy

Conditions
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Secondary Hyperparathyroidism, Renal Osteodystrophy

Intervention / Treatment
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* Drug: 1 alpha D2
* Drug: 1,25 dihydroxy vitamin D3
* Drug: Sevelamer HCl
* Drug: Calcium Carbonate


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: History of parathyroidectomy Growth hormone Prednisone, or other immunosuppressant medication within the past year. Recent history of medication non-compliance.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Doxercalciferol + Calcium Carbonate | Drug: 1 alpha D2<br>* Vitamin D sterol<br>* Other names: Hectoral;Drug: Calcium Carbonate<br>* Phosphate binder<br>* Other names: Titrilac;|
| Experimental: 2<br>Doxercalciferol + Sevelamer | Drug: 1 alpha D2<br>* Vitamin D sterol<br>* Other names: Hectoral;Drug: Sevelamer HCl<br>* Phosphate binder<br>* Other names: Renagel;|
| Experimental: 3<br>Calcitriol + Calcium Carbonate | Drug: 1,25 dihydroxy vitamin D3<br>* Active vitamin D sterol<br>* Other names: Rocaltrol;Drug: Calcium Carbonate<br>* Phosphate binder<br>* Other names: Titrilac;|
| Experimental: 4<br>Calcitriol + Sevelamer | Drug: 1,25 dihydroxy vitamin D3<br>* Active vitamin D sterol<br>* Other names: Rocaltrol;Drug: Sevelamer HCl<br>* Phosphate binder<br>* Other names: Renagel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Formation Rate |  | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone histomorphometric parameters other than bone formation rate, biochemical parameters (phosphorus, calcium, PTH, alkaline phosphatase, FGF-23, vitamin D dose) |  | 8 months |