Secondary Hyperparathyroidism Clinical Trial
Official title:
Regulation of Bone Formation in Renal Osteodystrophy
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
Status | Completed |
Enrollment | 61 |
Est. completion date | November 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 2 Years to 21 Years |
Eligibility |
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. |
Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bone Formation Rate | 8 months | ||
Secondary | Bone histomorphometric parameters other than bone formation rate, biochemical parameters (phosphorus, calcium, PTH, alkaline phosphatase, FGF-23, vitamin D dose) | 8 months |
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