Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-01-26 @ 9:13 PM
Study NCT ID:
NCT00131118
Status:
COMPLETED
Last Update Posted:
2017-06-01
First Post:
2005-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis Imperfecta
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010013', 'term': 'Osteogenesis Imperfecta'}], 'ancestors': [{'id': 'D010009', 'term': 'Osteochondrodysplasias'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003095', 'term': 'Collagen Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077211', 'term': 'Zoledronic Acid'}], 'ancestors': [{'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 127}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-31', 'studyFirstSubmitDate': '2005-08-15', 'studyFirstSubmitQcDate': '2005-08-15', 'lastUpdatePostDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Long-term safety of two different zoledronic acid doses over an additional 12 months in patients who have completed one year treatment in CZOL446H2202'}], 'secondaryOutcomes': [{'measure': 'Measure percentage change of lumbar spine bone mineral density at month 18 and 24 compared to baseline in the core study.'}]}, 'conditionsModule': {'keywords': ['Osteogenesis Imperfecta, Brittle bone disease, bisphosphonate, children'], 'conditions': ['Osteogenesis Imperfecta']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.novartisclinicaltrials.com/etrials/searchTrial.do?trialID=371', 'label': 'Novartis patient recruitment website'}]}, 'descriptionModule': {'briefSummary': 'This is an extension study to examine the long-term safety and efficacy of zoledronic acid in patients who have completed the core CZOL446H2202 study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '1 Year', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have completed the core CZOL446H2202 study\n* Males or females between 1-17 years of age\n\nExclusion Criteria:\n\n* Deformity or abnormality which would prevent spine bone density from being done\n* Any surgical bone-lengthening procedure\n* Any kidney diseases or abnormalities\n* Low calcium or vitamin D levels in the blood\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00131118', 'briefTitle': 'Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis Imperfecta', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Efficacy and Safety of Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis Imperfecta', 'orgStudyIdInfo': {'id': 'CZOL446H2202E1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Zoledronic Acid', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Medical Center-Dept of Pediatric Nephrology', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '19899', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'Alfred Dupont Hospital for Children', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '83702', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Intermountains Orthopedics', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': "Children's Hospital", 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'city': 'Multiple Locations', 'state': 'New Jersey', 'country': 'United States', 'facility': 'For information regarding facilities, please contact the Central Contact'}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health Sciences University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Children's Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}