Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-31 @ 2:26 AM
Study NCT ID:
NCT01128257
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2010-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Ibandronate [Bonviva/Boniva] and Alendronate in Female Patients With Post-Menopausal Osteoporosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015663', 'term': 'Osteoporosis, Postmenopausal'}], 'ancestors': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019386', 'term': 'Alendronate'}, {'id': 'D000077557', 'term': 'Ibandronic Acid'}], 'ancestors': [{'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6054}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2010-05-03', 'studyFirstSubmitQcDate': '2010-05-20', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of compliance and persistence of Bonviva therapy: Number of prescriptions, number of applied injections, number of taken oral medication, continuation and duration of treatment', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Pain intensity and reduction in use of analgesics', 'timeFrame': '12 months'}, {'measure': 'Quality of life and patients satisfaction', 'timeFrame': '12 months'}, {'measure': "Degree of patient's mobility", 'timeFrame': '12 months'}, {'measure': 'Incidence of new osteoporotic fractures', 'timeFrame': '12 months'}, {'measure': 'Controllability and management of therapy by the physician', 'timeFrame': '12 months'}, {'measure': 'Patient baseline characteristics', 'timeFrame': '12 months'}, {'measure': 'User friendliness', 'timeFrame': '12 months'}, {'measure': 'Safety: AEs and SAEs', 'timeFrame': '12 months'}]}, 'conditionsModule': {'conditions': ['Postmenopausal Osteoporosis']}, 'descriptionModule': {'briefSummary': 'This observational study will assess the compliance and persistence of patients, real life efficacy and safety of intravenously quarterly administered 3 mg ibandronate \\[Bonviva/Boniva\\] in comparison to oral alendronate generics in female patients with post-menopausal osteoporosis. The anticipated time of assessment is 12 months. The target sample size is 5000-7000 patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Female post-menopausal patients over the age of 55 years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, \\>/= 55 years of age\n* Postmenopausal osteoporosis\n* Patients who are in the opinion of the physician eligible to participate in this study\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT01128257', 'briefTitle': 'A Study of Ibandronate [Bonviva/Boniva] and Alendronate in Female Patients With Post-Menopausal Osteoporosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Controllability and Real Life Efficacy of Bonviva 3 mg iv Quarterly vs. Oral Alendronate Generics', 'orgStudyIdInfo': {'id': 'ML22927'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'interventionNames': ['Drug: ibandronate [Bonviva/Boniva]']}, {'label': '2', 'interventionNames': ['Drug: alendronate']}], 'interventions': [{'name': 'alendronate', 'type': 'DRUG', 'description': 'As prescribed by physician', 'armGroupLabels': ['2']}, {'name': 'ibandronate [Bonviva/Boniva]', 'type': 'DRUG', 'description': 'As prescribed by physician', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35043', 'city': 'Marburg', 'country': 'Germany', 'geoPoint': {'lat': 50.80904, 'lon': 8.77069}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}