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Regulation of Bone Formation in Renal Osteodystrophy

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ClinicalTrials.gov Identifier: NCT00560300
Recruitment Status : Completed
First Posted : November 19, 2007
Last Update Posted : January 14, 2010
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Description
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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
Secondary Hyperparathyroidism Renal Osteodystrophy 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
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Study Type : Interventional  (Clinical Trial)
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 : November 2000
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arms and Interventions
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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 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


Outcome Measures
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Primary Outcome Measures :
  1. Bone Formation Rate [ Time Frame: 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) [ Time Frame: 8 months ]

Eligibility Criteria
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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
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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
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Principal Investigator: Isidro B Salusky, MD University of California, Los Angeles
More Information
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ClinicalTrials.gov Identifier: NCT00560300    
Other Study ID Numbers: DK35423 (completed)
First Posted: November 19, 2007    Key Record Dates
Last Update Posted: January 14, 2010
Last Verified: January 2010
Additional relevant MeSH terms:
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Chronic Kidney Disease-Mineral and Bone Disorder
Hyperparathyroidism
Hyperparathyroidism, Secondary
Parathyroid Diseases
Endocrine System Diseases
Rickets
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Kidney Diseases
Urologic Diseases
Metabolic Diseases
Calcium Metabolism Disorders
Vitamin D Deficiency
Avitaminosis
 Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Cholecalciferol
Calcitriol
1 alpha-hydroxyergocalciferol
Dihydroxycholecalciferols
Calcium Carbonate
Calcium
Sevelamer
Vitamins
Micronutrients
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents