Regulation of Bone Formation in Renal Osteodystrophy

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)61 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Secondary Hyperparathyroidism Renal Osteodystrophy

Interventions

1 alpha D2DRUG

Vitamin D sterol

1,25 dihydroxy vitamin D3DRUG

Active vitamin D sterol

Sevelamer HClDRUG

Phosphate binder

Calcium Carbonate

Eligibility

Sex: ALLMin age: 2 YearsMax age: 21 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Bone Formation Rate

Time frame: 8 months

Secondary Outcomes

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

Time frame: 8 months

Data from ClinicalTrials.gov

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