Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-30 @ 10:24 PM
Study NCT ID:
NCT00377234
Status:
COMPLETED
Last Update Posted:
2016-08-01
First Post:
2006-09-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D000068296', 'term': 'Risedronic Acid'}, {'id': 'D000077557', 'term': 'Ibandronic Acid'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-LaRoche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Study duration was approximately 6 months (3 months and 12 weeks) and a follow-up period of 15 days after the completion of treatment was included to assess safety information. Participants were assessed for adverse events for a total of 6.5 months.', 'description': 'The safety analysis set is a modified intent to treat population, defined as all subjects who received the respective treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Ibandronate', 'description': 'Ibandronate adverse events', 'otherNumAtRisk': 327, 'otherNumAffected': 0, 'seriousNumAtRisk': 327, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Risedronate', 'description': 'Risendronate adverse events', 'otherNumAtRisk': 327, 'otherNumAffected': 0, 'seriousNumAtRisk': 327, 'seriousNumAffected': 3}], 'seriousEvents': [{'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 327, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 327, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 327, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 327, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Vitreous Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 327, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 327, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Abdominal Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 327, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 327, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Small Intestinal Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 327, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 327, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Umbilical Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 327, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 327, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Post Procedural Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 327, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 327, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Ovarian Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 327, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 327, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 327, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 327, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Malignant Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 327, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 327, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Preferred Ibandronate Monthly Dosing to Risedronate Weekly Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '278', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'During Sequence A', 'description': 'Ibandronate followed by risedronate'}, {'id': 'OG001', 'title': 'During Sequence B', 'description': 'Risendronate followed by ibandronate'}, {'id': 'OG002', 'title': 'Total', 'description': 'During period 1 + during period 2'}], 'classes': [{'categories': [{'measurements': [{'value': '81.7', 'groupId': 'OG000'}, {'value': '78.2', 'groupId': 'OG001'}, {'value': '79.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG002'], 'pValueComment': 'Null hypothesis: Preference rate (including patients not expressing treatment preference and considering order treatments were received) for monthly ibandronate = 50%. Null hypothesis is rejected if P-value was below significance threshold of P \\<0.05', 'statisticalMethod': 'Garts Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'pValueComment': 'The reported p-values for the primary analysis test whether the overall preference rate for ibandronate equals 50%. Preference within each sequence is not tested.', 'statisticalMethod': 'Prescott Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'at 6 months', 'description': 'Patients who had taken at least one dose of each study medication were asked to answer a Preference Questionnaire (answered by patients before any study procedures took place at the 6 month visit or at the early termination visit). The questionnaire included three questions on the preferred dosing schedule, and one question asking which schedule was more convenient. No assistance was allowed in completing the questionnaire.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat (mITT), defined as the safety analysis set excluding those participants who did not express a preference for one treatment'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Found Once-monthly Ibandronate to be More Convenient Than Once-weekly Risedronate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}, {'value': '262', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'During Sequence A', 'description': 'Ibandronate followed by risedronate'}, {'id': 'OG001', 'title': 'During Sequence B', 'description': 'Risedronate followed by ibandronate'}, {'id': 'OG002', 'title': 'Total', 'description': 'During period 1 + during period 2'}], 'classes': [{'categories': [{'measurements': [{'value': '85.5', 'groupId': 'OG000'}, {'value': '87.0', 'groupId': 'OG001'}, {'value': '86.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 6 months', 'description': 'Patients who had taken at least one dose of each study medication were asked to answer a Preference Questionnaire (answered by patients before any study procedures took place at the 6 month visit or at the early termination visit). The questionnaire included three questions on the preferred dosing schedule, and one question asking which schedule was more convenient. No assistance was allowed in completing the questionnaire.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT, defined as the safety analysis set excluding those participants who did not express a preference for one treatment'}, {'type': 'SECONDARY', 'title': 'Intensity of Upper Gastrointestinal (GI) Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibandronate', 'description': 'While being treated with ibandronate'}, {'id': 'OG001', 'title': 'Risedronate', 'description': 'While being treated with risendronate'}], 'classes': [{'title': 'Any', 'categories': [{'measurements': [{'value': '46.1', 'groupId': 'OG000'}, {'value': '56.5', 'groupId': 'OG001'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '41.3', 'groupId': 'OG000'}, {'value': '49.1', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '32.3', 'groupId': 'OG000'}, {'value': '36.0', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '15.6', 'groupId': 'OG000'}, {'value': '12.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 3 months', 'description': 'Patients were given a diary in which to record their upper GI events during the first 12 weeks of treatment. The diary was to be completed weekly and the occurrence of symptoms and their intensity recorded using a pre-defined list.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Bone Resorption and Bone Formation Markers, Serum C-telopeptide of α-chain of Type I Collagen (CTX) and Bone Specific Alkaline Phosphatase (BSAP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sequence A', 'description': 'ibandronate followed by risedronate'}, {'id': 'OG001', 'title': 'Sequence B', 'description': 'risedronate followed by ibandronate'}], 'timeFrame': '3 months', 'description': 'During the conduct of this study, it came to the attention of the sponsor that mislabeling of blood samples for the analysis of the bone turnover markers, serum CTX and BSAP, had occurred at more than half of the 44 clinical trial sites. As a result of this mislabeling, the bone turnover marker samples could not be assigned correctly to the two time points at which they were collected (samples collected at baseline and those collected at the crossover visit which occurred after 3 months following the start of trial treatment). Thus, the results of bone turnover markers could not be reliably assessed. Therefore, summary tables showing the mean and median change from baseline for both serum CTX and BSAP for patients randomized to Sequence A (3 months of ibandronate followed by 12 weeks of risedronate) or Sequence B (12 weeks of risedronate followed by 3 months of ibandronate) are not presented, as a valid interpretation of the data cannot be made.', 'reportingStatus': 'POSTED', 'populationDescription': 'Mislabeling of blood samples for analysis of bone turnover markers resulted in inability to correctly assign samples to two time points at which they were collected (baseline and crossover visit). Results could not be reliably assessed or reported.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline in Bone Resorption and Bone Formation Markers, Serum C-telopeptide of α-chain of Type I Collagen (CTX) and Bone Specific Alkaline Phosphatase (BSAP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sequence A', 'description': 'ibandronate followed by risedronate'}, {'id': 'OG001', 'title': 'Sequence B', 'description': 'risedronate followed by ibandronate'}], 'timeFrame': '3 months', 'description': 'During the conduct of this study, it came to the attention of the sponsor that mislabeling of blood samples for the analysis of the bone turnover markers, serum CTX and BSAP, had occurred at more than half of the 44 clinical trial sites. As a result of this mislabeling, the bone turnover marker samples could not be assigned correctly to the two time points at which they were collected (samples collected at baseline and those collected at the crossover visit which occurred after 3 months following the start of trial treatment). Thus, the results of bone turnover markers could not be reliably assessed. Therefore, summary tables showing the mean and median change from baseline for both serum CTX and BSAP for patients randomized to Sequence A (3 months of ibandronate followed by 12 weeks of risedronate) or Sequence B (12 weeks of risedronate followed by 3 months of ibandronate) are not presented, as a valid interpretation of the data cannot be made.', 'reportingStatus': 'POSTED', 'populationDescription': 'Mislabeling of blood samples for analysis of bone turnover markers resulted in inability to correctly assign samples to two time points at which they were collected (baseline and crossover visit). Results could not be reliably assessed or reported.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequence A', 'description': 'Ibandronate followed by risedronate'}, {'id': 'FG001', 'title': 'Sequence B', 'description': 'Risedronate followed by ibandronate'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '180'}, {'groupId': 'FG001', 'numSubjects': '176'}]}, {'type': 'Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '180'}, {'groupId': 'FG001', 'numSubjects': '176'}]}, {'type': 'Did Not Receive Study Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '177'}, {'groupId': 'FG001', 'numSubjects': '174'}]}, {'type': 'Safety Analysis Set: Period 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '177'}, {'groupId': 'FG001', 'numSubjects': '174'}]}, {'type': 'Safety Analysis Set: Period 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '153'}, {'groupId': 'FG001', 'numSubjects': '150'}]}, {'type': 'Safety Analysis Set: Ibandronate', 'achievements': [{'groupId': 'FG000', 'numSubjects': '177'}, {'groupId': 'FG001', 'numSubjects': '150'}]}, {'type': 'Safety Analysis Set: Risedronate', 'achievements': [{'groupId': 'FG000', 'numSubjects': '153'}, {'groupId': 'FG001', 'numSubjects': '174'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '146'}, {'groupId': 'FG001', 'numSubjects': '145'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '31'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Administrative', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Not assigned', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Of the 488 patients who were screened, 356 patients were enrolled into the study at 44 centers in the USA and randomized to treatment with ibandronate and risedronate. One hundred eighty patients were randomized to Sequence A (Period 1 ibandronate, Period 2 risedronate), and 176 patients to Sequence B (Period 1 risedronate, Period 2 ibandronate).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'BG000'}, {'value': '174', 'groupId': 'BG001'}, {'value': '351', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sequence A', 'description': 'Ibandronate followed by risedronate'}, {'id': 'BG001', 'title': 'Sequence B', 'description': 'Risedronate followed by ibandronate'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.6', 'spread': '7.0', 'groupId': 'BG000'}, {'value': '64.0', 'spread': '6.7', 'groupId': 'BG001'}, {'value': '64.3', 'spread': '6.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '177', 'groupId': 'BG000'}, {'value': '174', 'groupId': 'BG001'}, {'value': '351', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '177', 'groupId': 'BG000'}, {'value': '174', 'groupId': 'BG001'}, {'value': '351', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Safety Analysis Set'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 356}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-28', 'studyFirstSubmitDate': '2006-09-15', 'resultsFirstSubmitDate': '2015-06-25', 'studyFirstSubmitQcDate': '2006-09-15', 'lastUpdatePostDateStruct': {'date': '2016-08-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-06-25', 'studyFirstPostDateStruct': {'date': '2006-09-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Preferred Ibandronate Monthly Dosing to Risedronate Weekly Dosing', 'timeFrame': 'at 6 months', 'description': 'Patients who had taken at least one dose of each study medication were asked to answer a Preference Questionnaire (answered by patients before any study procedures took place at the 6 month visit or at the early termination visit). The questionnaire included three questions on the preferred dosing schedule, and one question asking which schedule was more convenient. No assistance was allowed in completing the questionnaire.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Found Once-monthly Ibandronate to be More Convenient Than Once-weekly Risedronate', 'timeFrame': 'within 6 months', 'description': 'Patients who had taken at least one dose of each study medication were asked to answer a Preference Questionnaire (answered by patients before any study procedures took place at the 6 month visit or at the early termination visit). The questionnaire included three questions on the preferred dosing schedule, and one question asking which schedule was more convenient. No assistance was allowed in completing the questionnaire.'}, {'measure': 'Intensity of Upper Gastrointestinal (GI) Symptoms', 'timeFrame': 'within 3 months', 'description': 'Patients were given a diary in which to record their upper GI events during the first 12 weeks of treatment. The diary was to be completed weekly and the occurrence of symptoms and their intensity recorded using a pre-defined list.'}, {'measure': 'Mean Change From Baseline in Bone Resorption and Bone Formation Markers, Serum C-telopeptide of α-chain of Type I Collagen (CTX) and Bone Specific Alkaline Phosphatase (BSAP)', 'timeFrame': '3 months', 'description': 'During the conduct of this study, it came to the attention of the sponsor that mislabeling of blood samples for the analysis of the bone turnover markers, serum CTX and BSAP, had occurred at more than half of the 44 clinical trial sites. As a result of this mislabeling, the bone turnover marker samples could not be assigned correctly to the two time points at which they were collected (samples collected at baseline and those collected at the crossover visit which occurred after 3 months following the start of trial treatment). Thus, the results of bone turnover markers could not be reliably assessed. Therefore, summary tables showing the mean and median change from baseline for both serum CTX and BSAP for patients randomized to Sequence A (3 months of ibandronate followed by 12 weeks of risedronate) or Sequence B (12 weeks of risedronate followed by 3 months of ibandronate) are not presented, as a valid interpretation of the data cannot be made.'}, {'measure': 'Median Change From Baseline in Bone Resorption and Bone Formation Markers, Serum C-telopeptide of α-chain of Type I Collagen (CTX) and Bone Specific Alkaline Phosphatase (BSAP)', 'timeFrame': '3 months', 'description': 'During the conduct of this study, it came to the attention of the sponsor that mislabeling of blood samples for the analysis of the bone turnover markers, serum CTX and BSAP, had occurred at more than half of the 44 clinical trial sites. As a result of this mislabeling, the bone turnover marker samples could not be assigned correctly to the two time points at which they were collected (samples collected at baseline and those collected at the crossover visit which occurred after 3 months following the start of trial treatment). Thus, the results of bone turnover markers could not be reliably assessed. Therefore, summary tables showing the mean and median change from baseline for both serum CTX and BSAP for patients randomized to Sequence A (3 months of ibandronate followed by 12 weeks of risedronate) or Sequence B (12 weeks of risedronate followed by 3 months of ibandronate) are not presented, as a valid interpretation of the data cannot be made.'}]}, 'conditionsModule': {'conditions': ['Post Menopausal Osteoporosis']}, 'descriptionModule': {'briefSummary': 'This 2 arm crossover study will evaluate patient reported preference for either once monthly Boniva (150mg p.o.) or once weekly risedronate (35mg p.o.). Patients with post-menopausal osteoporosis will be randomized to receive Boniva for 3 calendar months or risedronate for 12 weeks; they will then cross over to receive the alternative treatment for a further 12 weeks/3 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ambulatory women with post-menopausal osteoporosis;\n* patients who are bisphosphonate-naive, or who have previously received oral daily or i.v. bisphosphonate therapy (fulfilling certain criteria detailed in the protocol).\n\nExclusion Criteria:\n\n* malignant disease diagnosed within previous 10 years (except for successfully resected basal cell cancer;) breast cancer within previous 20 years;\n* inability to stand or sit upright for at least 60 minutes;\n* disease/disorder/treatment with drugs known to influence bone metabolism.'}, 'identificationModule': {'nctId': 'NCT00377234', 'briefTitle': 'A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Randomized, Open-label, Multi-center Study to Investigate Patient Preference on Dosing in Women With Postmenopausal Osteoporosis Treated With Once Monthly Ibandronate and Once Weekly Risedronate. A Six Month, Two-sequence and Two-period Crossover Study.', 'orgStudyIdInfo': {'id': 'MA19547'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: ibandronate [Bonviva/Boniva]']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Risedronate']}], 'interventions': [{'name': 'Risedronate', 'type': 'DRUG', 'description': '35mg po weekly for 12 weeks', 'armGroupLabels': ['2']}, {'name': 'ibandronate [Bonviva/Boniva]', 'type': 'DRUG', 'description': '150mg po monthly for 3 months', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294-3708', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85213', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85251', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '06708', 'city': 'Waterbury', 'state': 'Connecticut', 'country': 'United States', 'geoPoint': {'lat': 41.55815, 'lon': -73.0515}}, {'zip': '33437', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '33458', 'city': 'Jupiter', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.93422, 'lon': -80.09421}}, {'zip': '33777', 'city': 'Largo', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.90979, 'lon': -82.78842}}, {'zip': '34748', 'city': 'Leesburg', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.81082, 'lon': -81.87786}}, {'zip': '32952', 'city': 'Merritt Island', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.359, 'lon': -80.69}}, {'zip': '34471', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '33024', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '34667', 'city': 'Spring Hill', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.47688, 'lon': -82.52546}}, {'zip': '33606', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33614', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33409', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30134', 'city': 'Douglasville', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.7515, 'lon': -84.74771}}, {'zip': '30501', 'city': 'Gainesville', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 34.29788, 'lon': -83.82407}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '42431', 'city': 'Madisonville', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 37.3281, 'lon': -87.49889}}, {'zip': '20817', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '59801', 'city': 'Missoula', 'state': 'Montana', 'country': 'United States', 'geoPoint': {'lat': 46.87215, 'lon': -113.994}}, {'zip': '68134', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '28557', 'city': 'Morehead City', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 34.72294, 'lon': -76.72604}}, {'zip': '28562', 'city': 'New Bern', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.10849, 'lon': -77.04411}}, {'zip': '58401', 'city': 'Jamestown', 'state': 'North Dakota', 'country': 'United States', 'geoPoint': {'lat': 46.91054, 'lon': -98.70844}}, {'zip': '45224', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45236', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44260', 'city': 'Mogadore', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.04645, 'lon': -81.39789}}, {'zip': '74104', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '16635', 'city': 'Duncansville', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.42341, 'lon': -78.4339}}, {'zip': '16506', 'city': 'Erie', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 42.12922, 'lon': -80.08506}}, {'zip': '19053', 'city': 'Feasterville', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.15, 'lon': -74.997}}, {'zip': '19114', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29621', 'city': 'Anderson', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 34.50344, 'lon': -82.65013}}, {'zip': '38120', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '38375', 'city': 'Selmer', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 35.17008, 'lon': -88.59227}}, {'zip': '76021', 'city': 'Bedford', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.84402, 'lon': -97.14307}}, {'zip': '77802', 'city': 'Bryan', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.67436, 'lon': -96.36996}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77024', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '76502', 'city': 'Temple', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}, {'zip': '23235', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '23294', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}