Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT03411902
Status:
COMPLETED
Last Update Posted:
2021-02-09
First Post:
2018-01-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Weight Loss With Risedronate for Bone Health
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': 'beaverkm@wfu.edu', 'phone': '336-758-5855', 'title': 'Kristen Beavers', 'organization': 'Wake Forest School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'baseline through 12 months', 'eventGroups': [{'id': 'EG000', 'title': 'Risedronate', 'description': 'Experimental: Risedronate sodium,150 mg capsule once every 4 weeks for 24 weeks.\n\nRisedronate Sodium 150 MG: Subjects randomized to the Risedronate group will take a 150 mg capsule of oral Risedronate once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 4, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Active comparator: Identical 150 mg placebo capsules once every 4 weeks for 24 weeks.\n\nPlacebo: Participants randomized to the placebo group will receive 150 mg placebo capsule once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 3, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'gastroesophageal reflux disease exacerbation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'broken ankle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Broken humerus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Enrolled Participants That Completed All 24 Week Procedures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Risedronate', 'description': 'Experimental: Risedronate sodium,150 mg capsule once every 4 weeks for 24 weeks.\n\nRisedronate Sodium 150 MG: Subjects randomized to the Risedronate group will take a 150 mg capsule of oral Risedronate once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Active comparator: Identical 150 mg placebo capsules once every 4 weeks for 24 weeks.\n\nPlacebo: Participants randomized to the placebo group will receive 150 mg placebo capsule once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fat Pounds', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Risedronate', 'description': 'Experimental: Risedronate sodium,150 mg capsule once every 4 weeks for 24 weeks.\n\nRisedronate Sodium 150 MG: Subjects randomized to the Risedronate group will take a 150 mg capsule of oral Risedronate once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Active comparator: Identical 150 mg placebo capsules once every 4 weeks for 24 weeks.\n\nPlacebo: Participants randomized to the placebo group will receive 150 mg placebo capsule once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.6', 'groupId': 'OG000', 'lowerLimit': '41.8', 'upperLimit': '49.4'}, {'value': '40.6', 'groupId': 'OG001', 'lowerLimit': '37.9', 'upperLimit': '43.4'}]}]}], 'analyses': [{'pValue': '0.048', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'Duel-energy x-ray absorptiometry (DXA)-Acquired Measure--Fat pounds portion of Total body composition', 'unitOfMeasure': 'pounds', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '3 subjects were lost to follow up in the risedronate arm'}, {'type': 'SECONDARY', 'title': 'Lean Pounds', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Risedronate', 'description': 'Experimental: Risedronate sodium,150 mg capsule once every 4 weeks for 24 weeks.\n\nRisedronate Sodium 150 MG: Subjects randomized to the Risedronate group will take a 150 mg capsule of oral Risedronate once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Active comparator: Identical 150 mg placebo capsules once every 4 weeks for 24 weeks.\n\nPlacebo: Participants randomized to the placebo group will receive 150 mg placebo capsule once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.4', 'groupId': 'OG000', 'lowerLimit': '49.1', 'upperLimit': '51.8'}, {'value': '50.7', 'groupId': 'OG001', 'lowerLimit': '49.7', 'upperLimit': '51.7'}]}]}], 'analyses': [{'pValue': '0.745', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'Duel-energy x-ray absorptiometry (DXA)-Acquired Measure--Lean pounds portion of Total body composition', 'unitOfMeasure': 'pounds', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '3 subjects were lost to follow up in the risedronate arm'}, {'type': 'SECONDARY', 'title': 'Total Change in Femoral Neck Hip Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Risedronate', 'description': 'Experimental: Risedronate sodium,150 mg capsule once every 4 weeks for 24 weeks.\n\nRisedronate Sodium 150 MG: Subjects randomized to the Risedronate group will take a 150 mg capsule of oral Risedronate once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Active comparator: Identical 150 mg placebo capsules once every 4 weeks for 24 weeks.\n\nPlacebo: Participants randomized to the placebo group will receive 150 mg placebo capsule once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.028', 'groupId': 'OG000', 'lowerLimit': '-0.049', 'upperLimit': '-0.006'}, {'value': '-0.047', 'groupId': 'OG001', 'lowerLimit': '-0.063', 'upperLimit': '-0.030'}]}]}], 'analyses': [{'pValue': '0.163', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 weeks', 'description': 'Duel-energy x-ray absorptiometry (DXA)-Acquired Measure for Total Hip Density measured in g/cm\\^2', 'unitOfMeasure': 'g/cm^2', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Three subjects were lost to follow up in the risedronate arm.'}, {'type': 'SECONDARY', 'title': 'Total Change in Lumbar Spine Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Risedronate', 'description': 'Experimental: Risedronate sodium,150 mg capsule once every 4 weeks for 24 weeks.\n\nRisedronate Sodium 150 MG: Subjects randomized to the Risedronate group will take a 150 mg capsule of oral Risedronate once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Active comparator: Identical 150 mg placebo capsules once every 4 weeks for 24 weeks.\n\nPlacebo: Participants randomized to the placebo group will receive 150 mg placebo capsule once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.028', 'groupId': 'OG000', 'lowerLimit': '-0.006', 'upperLimit': '0.063'}, {'value': '-0.029', 'groupId': 'OG001', 'lowerLimit': '-0.054', 'upperLimit': '-0.004'}]}]}], 'analyses': [{'pValue': '0.013', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 weeks', 'description': 'Duel-energy x-ray absorptiometry (DXA)-Acquired Measure for Lumbar Spine Density measured in g/cm\\^2', 'unitOfMeasure': 'g/cm^2', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Three subjects were lost to follow up in the risedronate arm.'}, {'type': 'SECONDARY', 'title': 'Duel-energy X-ray Absorptiometry (DXA)-Acquired Measure for Ultradistal Radius (or UD Radius) Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Risedronate', 'description': 'Experimental: Risedronate sodium,150 mg capsule once every 4 weeks for 24 weeks.\n\nRisedronate Sodium 150 MG: Subjects randomized to the Risedronate group will take a 150 mg capsule of oral Risedronate once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Active comparator: Identical 150 mg placebo capsules once every 4 weeks for 24 weeks.\n\nPlacebo: Participants randomized to the placebo group will receive 150 mg placebo capsule once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.'}], 'classes': [{'title': 'Radius 33 BMD (g/cm^2)', 'categories': [{'measurements': [{'value': '-0.002', 'groupId': 'OG000', 'lowerLimit': '-0.027', 'upperLimit': '0.023'}, {'value': '-0.016', 'groupId': 'OG001', 'lowerLimit': '-0.036', 'upperLimit': '0.004'}]}]}, {'title': 'Radius UD BMD (g/cm^2)', 'categories': [{'measurements': [{'value': '0.000', 'groupId': 'OG000', 'lowerLimit': '-0.017', 'upperLimit': '0.017'}, {'value': '-0.013', 'groupId': 'OG001', 'lowerLimit': '-0.026', 'upperLimit': '0.001'}]}]}], 'analyses': [{'pValue': '0.337', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Pertaining to Radius 33 BMD', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.238', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Pertaining to Radius UD BMD', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'Total change in ultradistal radius density measure in g/cm\\^2', 'unitOfMeasure': 'g/cm^2', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Three subjects were lost to follow up in the risedronate arm.'}, {'type': 'SECONDARY', 'title': 'Trabecular Bone Score (TBS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Risedronate', 'description': 'Experimental: Risedronate sodium,150 mg capsule once every 4 weeks for 24 weeks.\n\nRisedronate Sodium 150 MG: Subjects randomized to the Risedronate group will take a 150 mg capsule of oral Risedronate once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Active comparator: Identical 150 mg placebo capsules once every 4 weeks for 24 weeks.\n\nPlacebo: Participants randomized to the placebo group will receive 150 mg placebo capsule once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.478', 'groupId': 'OG000', 'lowerLimit': '1.413', 'upperLimit': '1.543'}, {'value': '1.485', 'groupId': 'OG001', 'lowerLimit': '1.436', 'upperLimit': '1.533'}]}]}], 'analyses': [{'pValue': '0.860', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'TBS of the lumbar spine measured by two dimensional (2D) variogram acquired through duel-energy x-ray absorptiometry (DXA). Trabecular bone score is a unitless index of bone microarchitecture. A high TBS value means that bone microarchitecture is dense and well connected, with little space between trabeculae. The following normal range for TBS values in postmenopausal women has been proposed: TBS \\>=1.350 is considered to be normal; TBS between 1.200 and 1.350 is considered to be consistent with partially degraded microarchitecture; and TBS \\<=1.200 defines degraded microarchitecture', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Three subjects were lost to follow up in the risedronate arm.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Risedronate', 'description': 'Experimental: Risedronate sodium,150 mg capsule once every 4 weeks for 24 weeks.\n\nRisedronate Sodium 150 MG: Subjects randomized to the Risedronate group will take a 150 mg capsule of oral Risedronate once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Active comparator: Identical 150 mg placebo capsules once every 4 weeks for 24 weeks.\n\nPlacebo: Participants randomized to the placebo group will receive 150 mg placebo capsule once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Risedronate', 'description': 'Experimental: Risedronate sodium,150 mg capsule once every 4 weeks for 24 weeks.\n\nRisedronate Sodium 150 MG: Subjects randomized to the Risedronate group will take a 150 mg capsule of oral Risedronate once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Active comparator: Identical 150 mg placebo capsules once every 4 weeks for 24 weeks.\n\nPlacebo: Participants randomized to the placebo group will receive 150 mg placebo capsule once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.8', 'spread': '7.7', 'groupId': 'BG000'}, {'value': '57.3', 'spread': '5.7', 'groupId': 'BG001'}, {'value': '55.7', 'spread': '6.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-02', 'size': 165198, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-07-30T15:51', 'hasProtocol': False}, {'date': '2020-10-01', 'size': 586085, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-12-28T16:18', 'hasProtocol': True}, {'date': '2020-12-29', 'size': 54170, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-12-29T10:30', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'Both participant and research associate charged with administering medication or placebo capsules will be blinded.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This pilot study is a RCT, involving 24 sleeve gastrectomy patients randomized to Risedronate or placebo capsules for 24 weeks'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-21', 'studyFirstSubmitDate': '2018-01-11', 'resultsFirstSubmitDate': '2020-12-29', 'studyFirstSubmitQcDate': '2018-01-19', 'lastUpdatePostDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-29', 'studyFirstPostDateStruct': {'date': '2018-01-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Enrolled Participants That Completed All 24 Week Procedures', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'Fat Pounds', 'timeFrame': '24 weeks', 'description': 'Duel-energy x-ray absorptiometry (DXA)-Acquired Measure--Fat pounds portion of Total body composition'}, {'measure': 'Lean Pounds', 'timeFrame': '24 weeks', 'description': 'Duel-energy x-ray absorptiometry (DXA)-Acquired Measure--Lean pounds portion of Total body composition'}, {'measure': 'Total Change in Femoral Neck Hip Density', 'timeFrame': 'Baseline and 24 weeks', 'description': 'Duel-energy x-ray absorptiometry (DXA)-Acquired Measure for Total Hip Density measured in g/cm\\^2'}, {'measure': 'Total Change in Lumbar Spine Density', 'timeFrame': 'Baseline and 24 weeks', 'description': 'Duel-energy x-ray absorptiometry (DXA)-Acquired Measure for Lumbar Spine Density measured in g/cm\\^2'}, {'measure': 'Duel-energy X-ray Absorptiometry (DXA)-Acquired Measure for Ultradistal Radius (or UD Radius) Density', 'timeFrame': '24 weeks', 'description': 'Total change in ultradistal radius density measure in g/cm\\^2'}, {'measure': 'Trabecular Bone Score (TBS)', 'timeFrame': '24 weeks', 'description': 'TBS of the lumbar spine measured by two dimensional (2D) variogram acquired through duel-energy x-ray absorptiometry (DXA). Trabecular bone score is a unitless index of bone microarchitecture. A high TBS value means that bone microarchitecture is dense and well connected, with little space between trabeculae. The following normal range for TBS values in postmenopausal women has been proposed: TBS \\>=1.350 is considered to be normal; TBS between 1.200 and 1.350 is considered to be consistent with partially degraded microarchitecture; and TBS \\<=1.200 defines degraded microarchitecture'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bone Health'], 'conditions': ['Bariatric Surgery Candidate', 'Bone Loss', 'Weight Loss']}, 'referencesModule': {'references': [{'pmid': '33103032', 'type': 'DERIVED', 'citation': 'Swafford AA, Ard JD, Beavers DP, Gearren PC, Fernandez AZ, Ford SA, Greene KA, Kammire DE, Nesbit BA, Reed KK, Weaver AA, Beavers KM. Risedronate to Prevent Bone Loss After Sleeve Gastrectomy: Study Design and Feasibility Report of a Pilot Randomized Controlled Trial. JBMR Plus. 2020 Oct 2;4(10):e10407. doi: 10.1002/jbm4.10407. eCollection 2020 Oct.'}]}, 'descriptionModule': {'briefSummary': 'This is a pilot project to determine the feasibility of recruiting, enrolling, treating, and following 24 older sleeve gastrectomy patients into a randomized controlled trial (RCT) examining the efficacy of bisphosphonate use versus placebo in the prevention of surgical weight loss associated loss of bone mass and quality.', 'detailedDescription': 'This pilot study is a RCT, involving 24 participants randomized to Risedronate or placebo capsules for 24 weeks. All subjects planning a sleeve gastrectomy (SG) procedure will be approached during their pre-surgical evaluation for possible participation in the study. Eligible participants will be referred onto the study coordinator to read/sign an IRB-approved informed consent prior to enrollment.\n\nTwo in-person baseline assessment visits \\[baseline visit 1 (BV1), baseline visit 2 (BV2)\\] occurring 1-6 weeks prior to surgery, and two in-person follow up assessment visits \\[follow up visit 1 (FV1) and follow up visit 2 (FV2)\\] occurring ±2 weeks from their 23-week post-surgery date will be conducted, as well as monthly medication compliance reminders and adverse event reporting via phone. Optional additional exploratory assessments include CT-derive bone health and blood-based biomarkers, as well as 12-month DXA, CT, and blood assessments. The Wake Forest WMC, under the direction of Drs. Ard and Fernandez, will serve as a source of recruitment for potential study participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '40 Years', 'genderBased': True, 'genderDescription': 'Male and female', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Subjects planning a sleeve gastrectomy procedure\n* 40-79 yrs of age\n* Willingness to provide informed consent\n* Agreement to all study procedures and assessments\n\nExclusion Criteria\n\n* Age \\<40 years\n* Baseline weight \\>450 pounds\n* Chronic anti-reflux treatment\n* History of medical disorders known to affect bone metabolism\n* Use of bone-active medications\n* Known allergy to Risedronate'}, 'identificationModule': {'nctId': 'NCT03411902', 'acronym': 'WERISE', 'briefTitle': 'Weight Loss With Risedronate for Bone Health', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Effect of Bisphosphonate Use on Surgical Weight Loss Associated Bone Loss in Older Adults With Morbid Obesity', 'orgStudyIdInfo': {'id': 'IRB00048310'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Risedronate', 'description': 'Experimental: Risedronate sodium,150 mg capsule once every 4 weeks for 24 weeks.', 'interventionNames': ['Drug: Risedronate Sodium 150 MG']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Active comparator: Identical 150 mg placebo capsules once every 4 weeks for 24 weeks.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Risedronate Sodium 150 MG', 'type': 'DRUG', 'otherNames': ['Code A'], 'description': 'Subjects randomized to the Risedronate group will take a 150 mg capsule of oral Risedronate once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.', 'armGroupLabels': ['Risedronate']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['Code B'], 'description': 'Participants randomized to the placebo group will receive 150 mg placebo capsule once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27106', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Kristen M Beavers, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wake Forest University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}