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Regulation of Bone Formation in Renal Osteodystrophy

Primary Purpose

Secondary Hyperparathyroidism, Renal Osteodystrophy

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

1 alpha D2

1,25 dihydroxy vitamin D3

Sevelamer HCl

Calcium Carbonate

About this trial

This is an interventional treatment trial for Secondary Hyperparathyroidism

Eligibility Criteria

2 Years - 21 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Arm Description

Doxercalciferol + Calcium Carbonate

Doxercalciferol + Sevelamer

Calcitriol + Calcium Carbonate

Calcitriol + Sevelamer

Outcomes

Primary Outcome Measures

Bone Formation Rate

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00560300

First Posted

November 13, 2007

Last Updated

January 12, 2010

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT00560300

Brief Title

Regulation of Bone Formation in Renal Osteodystrophy

Official Title

Regulation of Bone Formation in Renal Osteodystrophy

Study Type

Interventional

2. Study Status

Record Verification Date

January 2010

Overall Recruitment Status

Completed

Study Start Date

November 2000 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

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

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Secondary Hyperparathyroidism, Renal Osteodystrophy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

61 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Doxercalciferol + Calcium Carbonate

Arm Title

Arm Type

Experimental

Arm Description

Doxercalciferol + Sevelamer

Arm Title

Arm Type

Experimental

Arm Description

Calcitriol + Calcium Carbonate

Arm Title

Arm Type

Experimental

Arm Description

Calcitriol + Sevelamer

Intervention Type

Drug

Intervention Name(s)

1 alpha D2

Other Intervention Name(s)

Doxercalciferol, Hectoral

Intervention Description

Vitamin D sterol

Intervention Type

Drug

Intervention Name(s)

1,25 dihydroxy vitamin D3

Other Intervention Name(s)

Calcitriol, Rocaltrol

Intervention Description

Active vitamin D sterol

Intervention Type

Drug

Intervention Name(s)

Sevelamer HCl

Other Intervention Name(s)

Renagel

Intervention Description

Phosphate binder

Intervention Type

Drug

Intervention Name(s)

Calcium Carbonate

Other Intervention Name(s)

Tums, Titrilac

Intervention Description

Phosphate binder

Primary Outcome Measure Information:

Title

Bone Formation Rate

Time Frame

8 months

Secondary Outcome Measure Information:

Title

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

Time Frame

8 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Isidro B Salusky, MD

Organizational Affiliation

University of California, Los Angeles

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Regulation of Bone Formation in Renal Osteodystrophy

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