Regulation of Bone Formation in Renal Osteodystrophy

January 12, 2010 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Doxercalciferol + Calcium Carbonate
Drug: 1 alpha D2
Vitamin D sterol
Other Names:
  • Hectoral
  • Doxercalciferol
Drug: Calcium Carbonate
Phosphate binder
Other Names:
  • Tums
  • Titrilac
Experimental: 2
Doxercalciferol + Sevelamer
Drug: 1 alpha D2
Vitamin D sterol
Other Names:
  • Hectoral
  • Doxercalciferol
Drug: Sevelamer HCl
Phosphate binder
Other Names:
  • Renagel
Experimental: 3
Calcitriol + Calcium Carbonate
Drug: Calcium Carbonate
Phosphate binder
Other Names:
  • Tums
  • Titrilac
Drug: 1,25 dihydroxy vitamin D3
Active vitamin D sterol
Other Names:
  • Calcitriol
  • Rocaltrol
Experimental: 4
Calcitriol + Sevelamer
Drug: Sevelamer HCl
Phosphate binder
Other Names:
  • Renagel
Drug: 1,25 dihydroxy vitamin D3
Active vitamin D sterol
Other Names:
  • Calcitriol
  • Rocaltrol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bone Formation Rate
Time Frame: 8 months
8 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2000

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

November 13, 2007

First Submitted That Met QC Criteria

November 16, 2007

First Posted (Estimate)

November 19, 2007

Study Record Updates

Last Update Posted (Estimate)

January 14, 2010

Last Update Submitted That Met QC Criteria

January 12, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DK35423 (completed)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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