Regulation of Bone Formation in Renal Osteodystrophy

National Institutes of Health (NIH)

Status and phase: Completed; Phase 2

Conditions: Renal Osteodystrophy; Secondary Hyperparathyroidism

Treatments: Drug: Calcium Carbonate; Drug: 1 alpha D2; Drug: Sevelamer HCl; Drug: 1,25 dihydroxy vitamin D3

Study type: Interventional

Funder types: NIH

Identifiers

NCT00560300

DK35423 (completed)

Details and patient eligibility

About

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

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 2 to 21 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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61 participants in 4 patient groups

1

Experimental group

Description:

Doxercalciferol + Calcium Carbonate

Treatment:

Drug: 1 alpha D2

Drug: Calcium Carbonate

2

Experimental group

Description:

Doxercalciferol + Sevelamer

Treatment:

Drug: Sevelamer HCl

Drug: 1 alpha D2

3

Experimental group

Description:

Calcitriol + Calcium Carbonate

Treatment:

Drug: 1,25 dihydroxy vitamin D3

Drug: Calcium Carbonate

4

Experimental group

Description:

Calcitriol + Sevelamer

Treatment:

Drug: 1,25 dihydroxy vitamin D3

Drug: Sevelamer HCl