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Regulation of Bone Formation in Renal Osteodystrophy

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00560300
First received: November 13, 2007
Last updated: January 12, 2010
Last verified: January 2010
History of Changes
  Purpose

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 Intervention Phase
Secondary Hyperparathyroidism
Renal Osteodystrophy
 Drug: 1 alpha D2
Drug: 1,25 dihydroxy vitamin D3
Drug: Sevelamer HCl
Drug: Calcium Carbonate
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Regulation of Bone Formation in Renal Osteodystrophy

Resource links provided by NLM:

MedlinePlus related topics: Calcium Vitamin D
U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Bone Formation Rate [ Time Frame: 8 months ]

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

Enrollment: 61
Study Start Date: November 2000
Study Completion Date: November 2006
Arms Assigned Interventions
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 Name: 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 Name: Renagel

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.

  Eligibility

Ages Eligible for Study:   2 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00560300

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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00560300     History of Changes
Other Study ID Numbers: DK35423 (completed)
Study First Received: November 13, 2007
Last Updated: January 12, 2010
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Renal Osteodystrophy
Parathyroid Diseases
Endocrine System Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Rickets
Kidney Diseases
Urologic Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Vitamin D Deficiency
Avitaminosis
 Deficiency Diseases
Malnutrition
Nutrition Disorders
Calcitriol
Cholecalciferol
Dihydroxycholecalciferols
Vitamin D
Ergocalciferols
Vitamins
1 alpha-hydroxyergocalciferol
Calcium Carbonate
Sevelamer
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013