Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2026-01-13 @ 10:29 AM
Study NCT ID:
NCT00560300
Status:
COMPLETED
Last Update Posted:
2010-01-14
First Post:
2007-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Regulation of Bone Formation in Renal Osteodystrophy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006962', 'term': 'Hyperparathyroidism, Secondary'}, {'id': 'D012080', 'term': 'Chronic Kidney Disease-Mineral and Bone Disorder'}], 'ancestors': [{'id': 'D006961', 'term': 'Hyperparathyroidism'}, {'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D012279', 'term': 'Rickets'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D002128', 'term': 'Calcium Metabolism Disorders'}, {'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C042533', 'term': '1 alpha-hydroxyergocalciferol'}, {'id': 'D002117', 'term': 'Calcitriol'}, {'id': 'D000069603', 'term': 'Sevelamer'}, {'id': 'D002119', 'term': 'Calcium Carbonate'}], 'ancestors': [{'id': 'D004100', 'term': 'Dihydroxycholecalciferols'}, {'id': 'D006887', 'term': 'Hydroxycholecalciferols'}, {'id': 'D002762', 'term': 'Cholecalciferol'}, {'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D011073', 'term': 'Polyamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D017610', 'term': 'Calcium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D002254', 'term': 'Carbonates'}, {'id': 'D002255', 'term': 'Carbonic Acid'}, {'id': 'D017554', 'term': 'Carbon Compounds, Inorganic'}, {'id': 'D008903', 'term': 'Minerals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-12', 'studyFirstSubmitDate': '2007-11-13', 'studyFirstSubmitQcDate': '2007-11-16', 'lastUpdatePostDateStruct': {'date': '2010-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone Formation Rate', 'timeFrame': '8 months'}], 'secondaryOutcomes': [{'measure': 'Bone histomorphometric parameters other than bone formation rate, biochemical parameters (phosphorus, calcium, PTH, alkaline phosphatase, FGF-23, vitamin D dose)', 'timeFrame': '8 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Secondary Hyperparathyroidism', 'Renal Osteodystrophy']}, 'referencesModule': {'references': [{'pmid': '40576086', 'type': 'DERIVED', 'citation': 'Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stable end-stage kidney disease treated with continuous cycling peritoneal dialysis,\n* Biochemical evidence of secondary hyperparathyroidism (PTH\\>400 pg/ml) with bone biopsy evidence of high turnover bone disease\n\nExclusion Criteria:\n\n* History of parathyroidectomy\n* Growth hormone\n* Prednisone, or other immunosuppressant medication within the past year.\n* Recent history of medication non-compliance.'}, 'identificationModule': {'nctId': 'NCT00560300', 'briefTitle': 'Regulation of Bone Formation in Renal Osteodystrophy', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'}, 'officialTitle': 'Regulation of Bone Formation in Renal Osteodystrophy', 'orgStudyIdInfo': {'id': 'DK35423 (completed)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Doxercalciferol + Calcium Carbonate', 'interventionNames': ['Drug: 1 alpha D2', 'Drug: Calcium Carbonate']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Doxercalciferol + Sevelamer', 'interventionNames': ['Drug: 1 alpha D2', 'Drug: Sevelamer HCl']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Calcitriol + Calcium Carbonate', 'interventionNames': ['Drug: 1,25 dihydroxy vitamin D3', 'Drug: Calcium Carbonate']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': 'Calcitriol + Sevelamer', 'interventionNames': ['Drug: 1,25 dihydroxy vitamin D3', 'Drug: Sevelamer HCl']}], 'interventions': [{'name': '1 alpha D2', 'type': 'DRUG', 'otherNames': ['Doxercalciferol', 'Hectoral'], 'description': 'Vitamin D sterol', 'armGroupLabels': ['1', '2']}, {'name': '1,25 dihydroxy vitamin D3', 'type': 'DRUG', 'otherNames': ['Calcitriol', 'Rocaltrol'], 'description': 'Active vitamin D sterol', 'armGroupLabels': ['3', '4']}, {'name': 'Sevelamer HCl', 'type': 'DRUG', 'otherNames': ['Renagel'], 'description': 'Phosphate binder', 'armGroupLabels': ['2', '4']}, {'name': 'Calcium Carbonate', 'type': 'DRUG', 'otherNames': ['Tums', 'Titrilac'], 'description': 'Phosphate binder', 'armGroupLabels': ['1', '3']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Isidro B Salusky, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}}}}