Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-26 @ 1:31 AM
Study NCT ID:
NCT00460733
Status:
COMPLETED
Last Update Posted:
2011-10-04
First Post:
2007-04-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SOLID-Effect of Risedronate Sodium at Distal Radius in Colle's Fracture.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003100', 'term': "Colles' Fracture"}], 'ancestors': [{'id': 'D000072039', 'term': 'Fracture Dislocation'}, {'id': 'D004204', 'term': 'Joint Dislocations'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D011885', 'term': 'Radius Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068296', 'term': 'Risedronic Acid'}, {'id': 'D002118', 'term': 'Calcium'}], 'ancestors': [{'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D008673', 'term': 'Metals, Alkaline Earth'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 141}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-03', 'studyFirstSubmitDate': '2007-04-13', 'studyFirstSubmitQcDate': '2007-04-13', 'lastUpdatePostDateStruct': {'date': '2011-10-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body mineral density of the 33% radius region and of the UD radius region', 'timeFrame': 'after 90 days of treatment'}], 'secondaryOutcomes': [{'measure': 'Body mineral density of the 33% radius region and of the UD radius region', 'timeFrame': 'after 180 days of treatment'}, {'measure': 'Size of callus obtained through Rx of the fracture site.', 'timeFrame': 'from the beginning up to the end of the study'}, {'measure': 'Safety: Adverse events occurrence.', 'timeFrame': 'from the inform consent signature up to the end of the study'}]}, 'conditionsModule': {'conditions': ["Colles' Fracture"]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of risedronate sodium (Actonel®) after a wrist fracture in postmenopausal women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women with description of 2 or more years of Menopause;\n* T-score \\<= -2.0 sd;\n* Confirmed colles'fracture;\n* Independent for the march (preserved ambulatorial ability);\n\nExclusion Criteria:\n\n* Co-morbidities;\n* Regular use of corticosteroids or other anti-resorptive drug in the last year;\n* Use of drugs that can affect the calcium metabolism;\n* Hypersensitivity to risedronate;\n* Previous wrist or forearm fracture;\n* Hypocalcemia;\n* Renal insufficiency;\n* Rheumatic disease;\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT00460733', 'acronym': 'SOLID', 'briefTitle': "SOLID-Effect of Risedronate Sodium at Distal Radius in Colle's Fracture.", 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': "Local (Brazil) Study, Multicenter, Opened, Comparative, Randomized, With Parallel Groups, Phase IV, in Post Menopausal Woman With Colles' Fracture of the Risedronate Sodium Usage in the Consolidation and in the Callus of the Colles'Fracture.", 'orgStudyIdInfo': {'id': 'RISED_L_01930'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Risedronate sodium']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Calcium & Vitamine D3']}], 'interventions': [{'name': 'Risedronate sodium', 'type': 'DRUG', 'description': 'Actonel® 35 mg (risedronate sodium) and 1000 mg of calcium and 400 UI of Vitamine D3', 'armGroupLabels': ['1']}, {'name': 'Calcium & Vitamine D3', 'type': 'DRUG', 'description': '1000 mg of calcium and 400 UI of Vitamine D3', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Jaderson Lima', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Procter and Gamble', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}