Regulation of Bone Formation in Renal Osteodystrophy

Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
Overall Status
Completed
CT.gov ID
NCT00560300
Collaborator
(none)
61
4
72

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: 1 alpha D2
  • Drug: 1,25 dihydroxy vitamin D3
  • Drug: Sevelamer HCl
  • Drug: Calcium Carbonate
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
61 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Regulation of Bone Formation in Renal Osteodystrophy
Study Start Date :
Nov 1, 2000
Actual Study Completion Date :
Nov 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Doxercalciferol + Calcium Carbonate

Drug: 1 alpha D2
Vitamin D sterol
Other Names:
  • Doxercalciferol
  • Hectoral
  • Drug: Calcium Carbonate
    Phosphate binder
    Other Names:
  • Tums
  • Titrilac
  • Experimental: 2

    Doxercalciferol + Sevelamer

    Drug: 1 alpha D2
    Vitamin D sterol
    Other Names:
  • Doxercalciferol
  • Hectoral
  • Drug: Sevelamer HCl
    Phosphate binder
    Other Names:
  • Renagel
  • Experimental: 3

    Calcitriol + Calcium Carbonate

    Drug: 1,25 dihydroxy vitamin D3
    Active vitamin D sterol
    Other Names:
  • Calcitriol
  • Rocaltrol
  • Drug: Calcium Carbonate
    Phosphate binder
    Other Names:
  • Tums
  • Titrilac
  • Experimental: 4

    Calcitriol + Sevelamer

    Drug: 1,25 dihydroxy vitamin D3
    Active vitamin D sterol
    Other Names:
  • Calcitriol
  • Rocaltrol
  • Drug: Sevelamer HCl
    Phosphate binder
    Other Names:
  • Renagel
  • Outcome Measures

    Primary Outcome Measures

    1. Bone Formation Rate [8 months]

    Secondary Outcome Measures

    1. Bone histomorphometric parameters other than bone formation rate, biochemical parameters (phosphorus, calcium, PTH, alkaline phosphatase, FGF-23, vitamin D dose) [8 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 21 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Isidro B Salusky, MD, University of California, Los Angeles

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00560300
    Other Study ID Numbers:
    • DK35423 (completed)
    First Posted:
    Nov 19, 2007
    Last Update Posted:
    Jan 14, 2010
    Last Verified:
    Jan 1, 2010

    Study Results

    No Results Posted as of Jan 14, 2010