IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
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) |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 |
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 |
ClinicalTrials.gov processed this record on August 16, 2017