Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT01802658
Status:
TERMINATED
Last Update Posted:
2018-02-28
First Post:
2013-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bone Demineralization Lesions in the Injured Marrow: Efficacy and Tolerability of Administration Early and Repeated the Zoledronic Acid. Comparative Study, Prospective, Double-blind Controlled (DBMZol)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'Recruiting Difficulty', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-26', 'studyFirstSubmitDate': '2013-02-28', 'studyFirstSubmitQcDate': '2013-02-28', 'lastUpdatePostDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-03-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Further study of biological markers of bone resorption', 'timeFrame': 'october 2015'}, {'measure': 'Study of bone architecture by QCT p', 'timeFrame': 'october 2015'}, {'measure': 'Establishment of a bio-collection.', 'timeFrame': 'october 2015'}, {'measure': 'Additional clinical follow-up study.', 'timeFrame': 'october 2015'}, {'measure': 'Medico-economic analysis.', 'timeFrame': 'october 2015'}], 'primaryOutcomes': [{'measure': 'determine DMO distal femur at 36 months', 'timeFrame': 'october 2015'}], 'secondaryOutcomes': [{'measure': 'Incidence of fractures of members lower in the first 36 months.', 'timeFrame': 'october 2015', 'description': 'to determine incidence of fractures of members lower in the first 36 months'}, {'measure': 'Response to the EQ-5D questionnaire at baseline, M12, M24, M36.', 'timeFrame': 'october 2015', 'description': 'To determine the EQ-5D'}, {'measure': 'DMO (g/cm2) at the distal femur, proximal femur, spine, total body M6, M12, M24, M36.', 'timeFrame': 'october 2015', 'description': 'Determine the DMO'}, {'measure': 'Bioassays: b CTX, PAO, PINP at M6, M12, M24, M36', 'timeFrame': 'october 2015', 'description': 'to measure bioassays'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Bone marrow demineralization lesions,: efficacy and tolerability, zoledronic acid'], 'conditions': ['Bone Demineralization Lesions in the Injured Marrow']}, 'descriptionModule': {'briefSummary': 'Subjects with lesion bone marrow are at risk of fracture by fragility bone. The median time to onset of fracture was 8.5 years. Fracture increases costs of care, dependency.\n\nBone fragility is secondary to hormonal disorders and calcium phosphate, impaired excretion of neuropeptides, vasomotor symptoms associated with the asset that promote bone loss and architectural disorganization. These phenomena occur in the first weeks of development of spinal cord injury and predominate in the distal femur and proximal tibia. From the third year, the demineralization stabilizes, bone mass is estimated to be between 70 and 50% of the initial bone mass, the new equilibrium.\n\nNo clinical evidence is predictive of fracture risk. A criteria surrogate must be used to assess this risk. There is an association between bone mineral density and fracture risk. The fracture threshold knee was evaluated to 0.87 g/cm2. Evaluation of bone mineral density in the distal femur is a predictor of fracture risk. Measure reliable and reproducible, easy to perform, it is a good element for monitoring the efficacy of anti-resorptive therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being diagnosed with a spinal cord injury less than 12 weeks of etiology stable,\n* level of injury C5 L2,\n* AIS grade A to D.\n* Female or male between 18 and 45 years.\n* No pregnancy.\n* No osteoporosis.\n* Good oral health.\n* Good glomerular filtration.\n* No cons-indication to Zoledronic Acid.\n* No drugs affecting bone metabolism\n\nExclusion Criteria:\n\n* pregnancy.\n* osteoporosis.\n* cons-indication to Zoledronic Acid.\n* drugs affecting bone metabolism'}, 'identificationModule': {'nctId': 'NCT01802658', 'acronym': 'DBMZol', 'briefTitle': 'Bone Demineralization Lesions in the Injured Marrow: Efficacy and Tolerability of Administration Early and Repeated the Zoledronic Acid. Comparative Study, Prospective, Double-blind Controlled (DBMZol)', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Bone Demineralization Lesions in the Injured Marrow: Efficacy and Tolerability of Administration Early and Repeated the Zoledronic Acid. Comparative Study, Prospective, Double-blind Controlled', 'orgStudyIdInfo': {'id': 'BRD/11/06-P'}, 'secondaryIdInfos': [{'id': '2012-001778-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Zoledronic acid', 'description': 'Zoledronic acid 5 mg. IV. 3 infusions. Administration 3 times over two years.', 'interventionNames': ['Drug: Zoledronic acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'NACL', 'description': 'NACl 100 ml IV. 3 infusions. Administration 3 times over two years.', 'interventionNames': ['Drug: NA Cl']}], 'interventions': [{'name': 'Zoledronic acid', 'type': 'DRUG', 'description': 'Zoledronic acid 5 mg. IV. 3 infusions. Administration 3 times inclusion M12 and M24 over two years.', 'armGroupLabels': ['Zoledronic acid']}, {'name': 'NA Cl', 'type': 'DRUG', 'description': 'NACl 100 ml IV. 3 infusions. Administration 3 times inclusion M12, M24 over two years.', 'armGroupLabels': ['NACL']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cervera de la Marenda', 'country': 'France', 'facility': 'Centre Bouffard - Vercelli CAP Cerbère', 'geoPoint': {'lat': 42.44094, 'lon': 3.16518}}, {'city': 'Les Herbiers', 'country': 'France', 'facility': 'CRMPR Les Herbiers', 'geoPoint': {'lat': 46.87095, 'lon': -1.0156}}, {'city': 'Montpellier', 'country': 'France', 'facility': 'Centre Mutualiste Neurologique Propara', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Nancy', 'country': 'France', 'facility': 'Institut Régional de Réadaptation Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '44000', 'city': 'Nantes', 'country': 'France', 'facility': 'University hospital of Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hôpital R. Poincaré', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'city': 'Saint-Saturnin', 'country': 'France', 'facility': "Centre de l'Arche", 'geoPoint': {'lat': 48.06461, 'lon': 0.16007}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'Hôpital Rangueil CHU', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}