Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-27 @ 11:04 PM
Study NCT ID:
NCT01290094
Status:
COMPLETED
Last Update Posted:
2015-08-13
First Post:
2011-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Bonviva/Boniva (Ibandronate) in Biphosphonate-Naïve 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': 'D000077557', 'term': 'Ibandronic Acid'}], 'ancestors': [{'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, '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': 'Baseline up to follow-up (Month 24)', 'description': 'ITT population.', 'eventGroups': [{'id': 'EG000', 'title': 'Ibandronate', 'description': 'Participants received 3 mg ibandronate via intravenous injection, every 3 months for 9 months (total of 4 injections).', 'otherNumAtRisk': 40, 'otherNumAffected': 20, 'seriousNumAtRisk': 40, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Gastrointestinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Flu like symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'Fractures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Eyelid disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Diabetic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Loss of conciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Gallbladder disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibandronate', 'description': 'Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).'}], 'classes': [{'categories': [{'measurements': [{'value': '5.67', 'spread': '7.86', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0005', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value for percent change from baseline was from a paired samples t-test.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12', 'description': 'Percent change was calculated as \\[(measure at time "t" minus \\[-\\] measure at baseline) divided by (/) measure at baseline\\] multiplied by (\\*) 100, where t=12 months. The baseline value is used as a reference to calculate the relative change from baseline.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}, {'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Mean Lumbar Spine BMD at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibandronate', 'description': 'Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).'}], 'classes': [{'categories': [{'measurements': [{'value': '5.27', 'spread': '8.00', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0005', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value for percent change from baseline was from a paired samples t-test.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 24', 'description': 'Percent change was calculated as \\[(measure at time "t" - measure at baseline)/measure at baseline\\]\\*100, where t=24 months. The baseline value is used as a reference to calculate the relative change from baseline.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Here "number of participants analyzed" included participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Mean Hip Bone BMD at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibandronate', 'description': 'Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.68', 'spread': '4.66', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value for percent change from baseline was from a paired samples t-test.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12', 'description': 'Percent change was calculated as \\[(measure at time "t" - measure at baseline)/measure at baseline\\]\\*100, where t=12 months. The baseline value is used as a reference to calculate the relative change from baseline.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}, {'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Mean Hip BMD at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibandronate', 'description': 'Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.71', 'spread': '5.09', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.056', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value for percent change from baseline was from a paired samples t-test.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 24', 'description': 'Percent change was calculated as \\[(measure at time "t" - measure at baseline)/measure at baseline\\]\\*100, where t=24 months. The baseline value is used as a reference to calculate the relative change from baseline.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Here "number of participants analyzed" included participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Lumbar Spine T-score at Month 12 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibandronate', 'description': 'Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).'}], 'classes': [{'title': 'Change at Month 12 (n=40)', 'categories': [{'measurements': [{'value': '13.47', 'spread': '12.23', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24 (n=35)', 'categories': [{'measurements': [{'value': '12.48', 'spread': '13.43', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0005', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Month 12: P-value for percent change from baseline was from a Wilcoxon signed rank test.', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0005', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Month 24: P-value for percent change from baseline was from a Wilcoxon signed rank test.', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12, Month 24', 'description': 'Percent change was calculated as \\[(measure at time "t" - measure at baseline)/measure at baseline\\]\\*100, where t=12 and 24 months. The baseline value is used as a reference to calculate the relative change from baseline. T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis. A T-score below -2.5 in combination with a prevalent fracture indicates serious osteoporosis.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Here "n" included participants who were evaluable at specified time point for the given arm.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Total Hip T-score at Month 12 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibandronate', 'description': 'Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).'}], 'classes': [{'title': 'Change at Month 12 (n=40)', 'categories': [{'measurements': [{'value': '9.31', 'spread': '16.75', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24 (n=35)', 'categories': [{'measurements': [{'value': '5.98', 'spread': '17.90', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0005', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Month 12: P-value for percent change from baseline was from a paired samples t-test.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.027', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Month 24: P-value for percent change from baseline was from a paired samples t-test.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12, Month 24', 'description': 'Percent change was calculated as \\[(measure at time "t" - measure at baseline)/measure at baseline\\]\\*100, where t=12 and 24 months. The baseline value is used as a reference to calculate the relative change from baseline. T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis. A T-score below -2.5 in combination with a prevalent fracture indicates serious osteoporosis.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Here "n" included participants who were evaluable at specified time point for the given arm.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Received All Planned Study Medication (Compliance)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibandronate', 'description': 'Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Month 12', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}, {'type': 'SECONDARY', 'title': "Correlation Coefficient of Participant's Profile With Compliance", 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibandronate', 'description': 'Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': "Since there was 100% compliance, it was decided not to perform the analysis of correlation coefficient of participant's Profile With Compliance.", 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Month 12', 'description': "Participant's profile included age, year since menopause, fracture history, and BMD at baseline.", 'unitOfMeasure': 'correlation coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ibandronate', 'description': 'Participants received 3 milligrams (mg) ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Ibandronate', 'description': 'Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.60', 'spread': '5.812', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat (ITT) population included participants who received at least 1 dose of study medication and at least 1 efficacy measurement was performed. One participant who was enrolled in the study initially, withdrew informed consent and was excluded from ITT population.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-17', 'studyFirstSubmitDate': '2011-01-20', 'resultsFirstSubmitDate': '2015-07-17', 'studyFirstSubmitQcDate': '2011-02-03', 'lastUpdatePostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-07-17', 'studyFirstPostDateStruct': {'date': '2011-02-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12', 'timeFrame': 'Baseline, Month 12', 'description': 'Percent change was calculated as \\[(measure at time "t" minus \\[-\\] measure at baseline) divided by (/) measure at baseline\\] multiplied by (\\*) 100, where t=12 months. The baseline value is used as a reference to calculate the relative change from baseline.'}, {'measure': 'Percent Change From Baseline in Mean Lumbar Spine BMD at Month 24', 'timeFrame': 'Baseline, Month 24', 'description': 'Percent change was calculated as \\[(measure at time "t" - measure at baseline)/measure at baseline\\]\\*100, where t=24 months. The baseline value is used as a reference to calculate the relative change from baseline.'}, {'measure': 'Percent Change From Baseline in Mean Hip Bone BMD at Month 12', 'timeFrame': 'Baseline, Month 12', 'description': 'Percent change was calculated as \\[(measure at time "t" - measure at baseline)/measure at baseline\\]\\*100, where t=12 months. The baseline value is used as a reference to calculate the relative change from baseline.'}, {'measure': 'Percent Change From Baseline in Mean Hip BMD at Month 24', 'timeFrame': 'Baseline, Month 24', 'description': 'Percent change was calculated as \\[(measure at time "t" - measure at baseline)/measure at baseline\\]\\*100, where t=24 months. The baseline value is used as a reference to calculate the relative change from baseline.'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline in Lumbar Spine T-score at Month 12 and 24', 'timeFrame': 'Baseline, Month 12, Month 24', 'description': 'Percent change was calculated as \\[(measure at time "t" - measure at baseline)/measure at baseline\\]\\*100, where t=12 and 24 months. The baseline value is used as a reference to calculate the relative change from baseline. T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis. A T-score below -2.5 in combination with a prevalent fracture indicates serious osteoporosis.'}, {'measure': 'Percent Change From Baseline in Total Hip T-score at Month 12 and 24', 'timeFrame': 'Baseline, Month 12, Month 24', 'description': 'Percent change was calculated as \\[(measure at time "t" - measure at baseline)/measure at baseline\\]\\*100, where t=12 and 24 months. The baseline value is used as a reference to calculate the relative change from baseline. T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis. A T-score below -2.5 in combination with a prevalent fracture indicates serious osteoporosis.'}, {'measure': 'Percentage of Participants Who Received All Planned Study Medication (Compliance)', 'timeFrame': 'Baseline up to Month 12'}, {'measure': "Correlation Coefficient of Participant's Profile With Compliance", 'timeFrame': 'Baseline up to Month 12', 'description': "Participant's profile included age, year since menopause, fracture history, and BMD at baseline."}]}, 'conditionsModule': {'conditions': ['Post Menopausal Osteoporosis']}, 'descriptionModule': {'briefSummary': 'This single arm, open label study will assess the efficacy and safety of and compliance to treatment with Bonviva/Boniva (ibandronate) in biphosphonate-naïve patients with post-menopausal osteoporosis. Patients will receive Bonviva/Boniva at a dose of 3 mg intravenously every three months. Anticipated time on study treatment is 12 months with a follow-up of 12 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients, \\> 50 years of age\n* Diagnosed osteoporosis\n* Bone mineral density \\< minus 2.5 SD or osteoporotic fracture\n* At least 3 years after menopause\n\nExclusion Criteria:\n\n* Impaired renal function\n* Contra-indication to Calcium or Vitamin D therapy\n* Previous or current treatment with biphosphonates'}, 'identificationModule': {'nctId': 'NCT01290094', 'briefTitle': 'A Study of Bonviva/Boniva (Ibandronate) in Biphosphonate-Naïve Women With Post-Menopausal Osteoporosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Interventional, Single Arm, Open Label Study of the Efficacy, Safety and Compliance to the Treatment With Intravenous (IV) Ibandronate (Bonviva®) in the Postmenopausal Osteoporosis Treatment of Bisphosphonates naïve Patients in Daily Practice', 'orgStudyIdInfo': {'id': 'ML25399'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Arm', 'interventionNames': ['Drug: ibandronate [Bonviva/Boniva]']}], 'interventions': [{'name': 'ibandronate [Bonviva/Boniva]', 'type': 'DRUG', 'description': '3 mg intravenously every 3 months', 'armGroupLabels': ['Single Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78000', 'city': 'Banja Luka', 'country': 'Bosnia and Herzegovina', 'geoPoint': {'lat': 44.77879, 'lon': 17.20629}}, {'zip': '71000', 'city': 'Sarajevo', 'country': 'Bosnia and Herzegovina', 'geoPoint': {'lat': 43.84864, 'lon': 18.35644}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}