Regulation of Bone Formation in Renal Osteodystrophy
This study has been completed.
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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
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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:
Genetics Home Reference related topics:
hereditary hypophosphatemic rickets
Drug Information available for:
Calcium Gluconate
Calcium carbonate
Vitamin D
Calcitriol
Sevelamer
Doxercalciferol
Sevelamer hydrochloride
Sevelamer carbonate
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:
Drug: Calcium Carbonate
Phosphate binder
Other Names:
|
|
Experimental: 2
Doxercalciferol + Sevelamer
|
Drug: 1 alpha D2
Vitamin D sterol
Other Names:
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:
Drug: Calcium Carbonate
Phosphate binder
Other Names:
|
|
Experimental: 4
Calcitriol + Sevelamer
|
Drug: 1,25 dihydroxy vitamin D3
Active vitamin D sterol
Other Names:
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 (Child, Adult) |
| 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00560300
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
| 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 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 Cholecalciferol 1 alpha-hydroxyergocalciferol Calcitriol Dihydroxycholecalciferols Calcium, Dietary Calcium Carbonate Sevelamer Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on September 30, 2016