Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:16 AM
Study NCT ID:
NCT04012320
Status:
COMPLETED
Last Update Posted:
2019-07-09
First Post:
2019-06-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety on the Use of Bisphosphonates in Paediatrics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059266', 'term': 'Bisphosphonate-Associated Osteonecrosis of the Jaw'}], 'ancestors': [{'id': 'D010020', 'term': 'Osteonecrosis'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-08', 'studyFirstSubmitDate': '2019-06-14', 'studyFirstSubmitQcDate': '2019-07-08', 'lastUpdatePostDateStruct': {'date': '2019-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fracture rates', 'timeFrame': '2 years', 'description': '(numbers)'}, {'measure': 'bone mineral density', 'timeFrame': '2 years', 'description': '(Z-score)'}, {'measure': 'pain frequency', 'timeFrame': '2 years', 'description': '(never, occasional, regular)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bone Fragile', 'Bisphosphonate-Associated Osteonecrosis', 'Children', 'Adverse Events']}, 'descriptionModule': {'briefSummary': 'The investigators suppose that the impact of bisphosphonate therapy is beneficial on the bone during the growth period with few adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients under 18 years old who started intravenous bisphosphonates for primary or secondary osteoporosis in paediatric departments of Montpellier and Nimes University Hospitals between January 2012 and August 2018 were included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* be under 18 years of age\n* have been treated by intravenous bisphosphonates for primary or secondary osteoporosis\n\nExclusion Criteria:\n\n* be over 18 years of age'}, 'identificationModule': {'nctId': 'NCT04012320', 'acronym': 'Bisphosphonate', 'briefTitle': 'Efficacy and Safety on the Use of Bisphosphonates in Paediatrics', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Efficacy and Safety on the Use of Bisphosphonates in Paediatrics', 'orgStudyIdInfo': {'id': 'Local/2018/TAT-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pamidronate therapy', 'interventionNames': ['Other: No intervention, observational study']}, {'label': 'Zoledronate therapy', 'interventionNames': ['Other: No intervention, observational study']}], 'interventions': [{'name': 'No intervention, observational study', 'type': 'OTHER', 'description': 'No intervention, observational study', 'armGroupLabels': ['Pamidronate therapy', 'Zoledronate therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nîmes', 'country': 'France', 'facility': 'CHUNimes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}