Regulation of Bone Formation in Renal Osteodystrophy
Study Details
Study Description
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 |
---|---|---|
|
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
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
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 Names:
|
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 Names:
|
Outcome Measures
Primary Outcome Measures
- Bone Formation Rate [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) [8 months]
Eligibility Criteria
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
Locations
No locations specified.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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DK35423 (completed)