Regulation of Bone Formation in Renal Osteodystrophy
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ClinicalTrials.gov Identifier: NCT00560300 |
Recruitment Status :
Completed
First Posted : November 19, 2007
Last Update Posted : January 14, 2010
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Condition or disease | Intervention/treatment | 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 (Clinical Trial) |
Actual Enrollment : | 61 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Regulation of Bone Formation in Renal Osteodystrophy |
Study Start Date : | November 2000 |
Actual Study Completion Date : | November 2006 |
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 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 |
- Bone Formation Rate [ Time Frame: 8 months ]
- Bone histomorphometric parameters other than bone formation rate, biochemical parameters (phosphorus, calcium, PTH, alkaline phosphatase, FGF-23, vitamin D dose) [ Time Frame: 8 months ]

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Ages Eligible for Study: | 2 Years to 21 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00560300
Principal Investigator: | Isidro B Salusky, MD | University of California, Los Angeles |
ClinicalTrials.gov Identifier: | NCT00560300 |
Other Study ID Numbers: |
DK35423 (completed) |
First Posted: | November 19, 2007 Key Record Dates |
Last Update Posted: | January 14, 2010 |
Last Verified: | January 2010 |
Chronic Kidney Disease-Mineral and Bone Disorder Hyperparathyroidism Hyperparathyroidism, Secondary Parathyroid Diseases Endocrine System Diseases Rickets Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Kidney Diseases Urologic Diseases Metabolic Diseases Calcium Metabolism Disorders Vitamin D Deficiency Avitaminosis |
Deficiency Diseases Malnutrition Nutrition Disorders Vitamin D Cholecalciferol Calcitriol 1 alpha-hydroxyergocalciferol Dihydroxycholecalciferols Calcium Carbonate Calcium Sevelamer Vitamins Micronutrients Physiological Effects of Drugs Calcium-Regulating Hormones and Agents |