Ignite Creation Date:
2025-12-24 @ 2:10 PM
Ignite Modification Date:
2026-02-25 @ 12:57 AM
Study NCT ID:
NCT00577395
Status:
TERMINATED
Last Update Posted:
2013-04-22
First Post:
2007-12-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bone Microarchitecture in Osteopenic Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'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'}], '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': {'email': 'gwulff@wcrx.com', 'phone': '973-442-3376', 'title': 'Grexan Wulff, Manager Regulatory Affairs', 'organization': 'Warner Chilcott'}, 'certainAgreement': {'otherDetails': 'The Study Site and Principal Investigator agree that all data, calculations, interpretations, opinions, and recommendations regarding the study will be the property of the Sponsor. The Study Site and Principal Investigator agree to consider the results as confidential information subject to use restrictions.\n\nThe names of the Investigator(s) will not be used by P\\&GP for commercial purposes without appropriate written permission, unless required by law or government regulation.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'NOTE: The study was terminated early (after 5 months), prior to acquiring any efficacy endpoints; consequently, NO subject efficacy analyses were performed'}}, 'adverseEventsModule': {'timeFrame': "From the point of study enrolment until the subject's last observation.", 'description': 'Specific safety parameters and procedures were to include vital signs, serum chemistry panel/hematology/urinalysis, and recording of AEs, including moderate-to-severe upper GI events and clinical fractures.', 'eventGroups': [{'id': 'EG000', 'title': 'One 150 mg Risedronate Once a Month', 'description': 'one 150 mg risedronate once a month, orally', 'otherNumAtRisk': 7, 'otherNumAffected': 2, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Tablet Once a Month', 'description': 'Placebo tablet once a month, orally', 'otherNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abdominal distension'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Pharyngitis'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Blood pressure incre'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Ear infection'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Erosion Index (A Ratio of Curve-like Structures to Plate-like Structures and is a Measure of the Degree of Structural Degradation) of the Distal Radius', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One 150 mg Risedronate Once a Month', 'description': 'one 150 mg risedronate once a month, orally'}, {'id': 'OG001', 'title': 'Placebo Tablet Once a Month', 'description': 'Placebo tablet once a month, orally'}], 'timeFrame': '12 months', 'description': 'The percent was change from baseline in erosion index at the distal radius between the risedronate and placebo groups at Month 12 (the lower the percent change in erosion index, the greater the improvement of structural degradation); the last valid postbaseline measurement was to be used when the Month 12 value was missing (Last Observation Carried Forward or LOCF).\n\nNOTE: The study was unable to recruit sufficient numbers of patients to meet with the protocol specified numbers, thus it was terminated early after 5 months. No efficacy analyses were performed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated prior to acquiring any efficacy endpoints. No efficacy analyses were performed.'}, {'type': 'SECONDARY', 'title': 'Erosion Index of the Distal Radius', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One 150 mg Risedronate Once a Month', 'description': 'one 150 mg risedronate once a month, orally'}, {'id': 'OG001', 'title': 'Placebo Tablet Once a Month', 'description': 'Placebo tablet once a month, orally'}], 'timeFrame': '6 months', 'description': 'Study was terminated prior to acquiring any efficacy endpoints. No efficacy analyses were performed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated prior to acquiring any efficacy endpoints. No efficacy analyses were performed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'One 150 mg Risedronate Once a Month', 'description': 'one 150 mg risedronate once a month, orally'}, {'id': 'FG001', 'title': 'Placebo Tablet Once a Month', 'description': 'Placebo tablet once a month, orally'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '67 planned for Treatment 2, but due to enrollment difficulties this was not met.', 'groupId': 'FG000', 'numSubjects': '7'}, {'comment': '67 were planned for Treatment 1, but due to enrollment difficulties this was not met.', 'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'The study was terminated early by the Sponsor for lack of enrollment', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'The study was terminated early by the Sponsor for lack of enrollment', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Study was terminated early by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'Beginning with the first patient screened on June 18th, 2008, a total of 51 patients were screened for inclusion into the study, of which 38 were excluded from further participation.', 'preAssignmentDetails': 'The Screening visit was conducted within 45 days of randomization. After obtaining written informed consent, patients underwent a preliminary screening, including Dual Energy X-ray Absorptiometry (DXA) of the lumbar spine and proximal femur. The most frequent reason for screening failure was DXA results.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'One 150 mg Risedronate Once a Month', 'description': 'one 150 mg risedronate once a month, orally'}, {'id': 'BG001', 'title': 'Placebo Tablet Once a Month', 'description': 'Placebo tablet once a month, orally'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.42', 'spread': '2.50', 'groupId': 'BG000'}, {'value': '53.83', 'spread': '2.63', 'groupId': 'BG001'}, {'value': '52.53', 'spread': '2.75', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', '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': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Argentina', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-15', 'studyFirstSubmitDate': '2007-12-19', 'resultsFirstSubmitDate': '2009-11-18', 'studyFirstSubmitQcDate': '2007-12-19', 'lastUpdatePostDateStruct': {'date': '2013-04-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-11-18', 'studyFirstPostDateStruct': {'date': '2007-12-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline in Erosion Index (A Ratio of Curve-like Structures to Plate-like Structures and is a Measure of the Degree of Structural Degradation) of the Distal Radius', 'timeFrame': '12 months', 'description': 'The percent was change from baseline in erosion index at the distal radius between the risedronate and placebo groups at Month 12 (the lower the percent change in erosion index, the greater the improvement of structural degradation); the last valid postbaseline measurement was to be used when the Month 12 value was missing (Last Observation Carried Forward or LOCF).\n\nNOTE: The study was unable to recruit sufficient numbers of patients to meet with the protocol specified numbers, thus it was terminated early after 5 months. No efficacy analyses were performed.'}], 'secondaryOutcomes': [{'measure': 'Erosion Index of the Distal Radius', 'timeFrame': '6 months', 'description': 'Study was terminated prior to acquiring any efficacy endpoints. No efficacy analyses were performed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoporosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to compare the difference in bone microarchitecture of the distal radius at month 12 in postmenopausal osteopenic women treated with risedronate 150mg taken once a month compared to placebo.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '57 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female: 40 and 57 years of age inclusive\n* cessation of menstruation (surgical or natural) between 12 and 36 months prior to study enrollment\n* have osteopenia defines as having the following: have osteopenia defined as having the following:\n* Lumbar spine (L1-L4) Bone Mineral Density (BMD) T score -1 and less than -2.5 AND a total hip T score of greater than -2.5 OR\n* Lumbar spine (L1-L4) BMD T score greater than -2.5 AND a total hip T score -1 and less than -2.5;\n* have a body mass index (BMI) between 18 and 30 kg/m2.\n\nExclusion Criteria:\n\n* history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia\n* use of medications within 3 months of starting study drug that impact bone metabolism such as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates and parathyroid hormone\n* hypocalcemia or hypercalcemia of any cause'}, 'identificationModule': {'nctId': 'NCT00577395', 'briefTitle': 'Bone Microarchitecture in Osteopenic Postmenopausal Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'Warner Chilcott'}, 'officialTitle': 'A 12-month, Multicenter, Double-blind, Randomized, Parallel Group Study Comparing 150 mg Once-a-month Risedronate and Placebo Using 3-dimensional Micro MRI (Magnetic Resonance Imaging).', 'orgStudyIdInfo': {'id': '2007075'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2', 'description': 'one 150 mg risedronate once a month, orally', 'interventionNames': ['Drug: risedronate']}, {'type': 'PLACEBO_COMPARATOR', 'label': '1', 'description': 'Placebo tablet once a month, orally', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'placebo', 'type': 'DRUG', 'description': 'oral tablet once a month for 12 months', 'armGroupLabels': ['1']}, {'name': 'risedronate', 'type': 'DRUG', 'description': 'tablet, 150 mg once a month for 12 months', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85704', 'city': 'Tuscon', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Facility'}, {'zip': '68729', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Research Facility', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '45201', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Research Facility', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}], 'overallOfficials': [{'name': 'Ana M Balske, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Procter and Gamble'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Warner Chilcott', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Sanofi', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}