Renal Osteodystrophy, Secondary Hyperparathyroidism
Conditions
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
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.
Interventions
DRUG1 alpha D2
Vitamin D sterol
DRUG1,25 dihydroxy vitamin D3
Active vitamin D sterol
DRUGSevelamer HCl
Phosphate binder
DRUGCalcium Carbonate
Phosphate binder
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 21 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone Formation Rate | 8 months |
Secondary
| Measure | Time frame |
|---|---|
| Bone histomorphometric parameters other than bone formation rate, biochemical parameters (phosphorus, calcium, PTH, alkaline phosphatase, FGF-23, vitamin D dose) | 8 months |
Outcome results
None listed