Regulation of Bone Formation in Renal Osteodystrophy

Secondary Hyperparathyroidism Clinical Trial

Official title:

Regulation of Bone Formation in Renal Osteodystrophy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00560300
• Other study ID #: DK35423 (completed)
• Status: Completed
• Phase: Phase 2
• First received: November 13, 2007
• Last updated: January 12, 2010
• Start date: November 2000
• Est. completion date: November 2006

Study information

• Verified date: January 2010
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 21 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Renal Osteodystrophy
• Secondary Hyperparathyroidism

Intervention

Drug:
• 1 alpha D2
Vitamin D sterol
• 1,25 dihydroxy vitamin D3
Active vitamin D sterol
• Sevelamer HCl
Phosphate binder
• Calcium Carbonate
Phosphate binder

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Formation Rate		8 months
Secondary	Bone histomorphometric parameters other than bone formation rate, biochemical parameters (phosphorus, calcium, PTH, alkaline phosphatase, FGF-23, vitamin D dose)		8 months