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Regulation of Bone Formation in Renal Osteodystrophy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00560300
First Posted: November 19, 2007
Last Update Posted: January 14, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  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: None (Open Label)
Primary Purpose: Treatment
Official Title: Regulation of Bone Formation in Renal Osteodystrophy

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00560300     History of Changes
Other Study ID Numbers: DK35423 (completed)
First Submitted: November 13, 2007
First Posted: November 19, 2007
Last Update Posted: January 14, 2010
Last Verified: January 2010

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