Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-01-01 @ 3:44 AM
Study NCT ID:
NCT04922333
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2021-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bisphosphonate Use to Mitigate Bone Loss Secondary to Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Both participants and study staff will be blinded to treatment allocation.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2021-06-04', 'studyFirstSubmitQcDate': '2021-06-04', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Biomarkers of Bone Turnover, Metabolism, and Bone-Muscle Crosstalk', 'timeFrame': 'Baseline, Month 6, Month 12', 'description': 'Blood drawn for collection of biomarkers.'}, {'measure': 'High Resolution peripheral Quantitative Computed Tomography (HRpQCT)-Acquired Distal Tibia Failure Load', 'timeFrame': 'Baseline, Month 6, Month 12'}, {'measure': 'HRpQCT-Acquired Distal Tibia Bones Stiffness', 'timeFrame': 'Baseline, Month 6, Month 12'}, {'measure': 'HRpQCT-Acquired Distal Radius Failure Load', 'timeFrame': 'Baseline, Month 6, Month 12'}, {'measure': 'HRpQCT-Acquired Distal Radius Bone Stiffness', 'timeFrame': 'Baseline, Month 6, Month 12'}, {'measure': 'HRpQCT-Acquired Distal Tibia Trabecular Number', 'timeFrame': 'Baseline, Month 6, Month 12'}, {'measure': 'HRpQCT-Acquired Distal Tibia Trabecular Thickness', 'timeFrame': 'Baseline, Month 6, Month 12'}, {'measure': 'HRpQCT-Acquired Distal Tibia Trabecular Separation', 'timeFrame': 'Baseline, Month 6, Month 12'}, {'measure': 'HRpQCT-Acquired Distal Tibia Cortical Thickness', 'timeFrame': 'Baseline, Month 6, Month 12'}, {'measure': 'HRpQCT-Acquired Distal Tibia Cortical Porosity', 'timeFrame': 'Baseline, Month 6, Month 12'}, {'measure': 'HRpQCT-Acquired Distal Tibia Cortical Volumetric Bone Mineral Density', 'timeFrame': 'Baseline, Month 6, Month 12'}, {'measure': 'HRpQCT-Acquired Distal Tibia Trabecular Volumetric Bone Mineral Density', 'timeFrame': 'Baseline, Month 6, Month 12'}], 'primaryOutcomes': [{'measure': 'Change in Total Hip Areal Bone Mineral Density (aBMD)', 'timeFrame': 'baseline through Month 6', 'description': 'Acquired through DXA scans.'}, {'measure': 'Change in Total Hip Areal Bone Mineral Density (aBMD)', 'timeFrame': 'baseline through Month 12', 'description': 'Acquired through DXA scans.'}], 'secondaryOutcomes': [{'measure': 'Dual Energy X-Ray Absorptiometry (DXA)-acquired Femoral Neck Measurements', 'timeFrame': 'Baseline, Month 6, Month 12'}, {'measure': 'DXA-acquired Lumbar Spine Measurements', 'timeFrame': 'Baseline, Month 6, Month 12'}, {'measure': 'DXA-acquired Distal Radius Areal BMD Measurements', 'timeFrame': 'Baseline, Month 6, Month 12'}, {'measure': 'DXA-acquired Appendicular Lean Mass Measurements', 'timeFrame': 'Baseline, Month 6, Month 12'}, {'measure': 'Quantitative Computed Tomography (QCT) Acquired Compartmental Volumetric BMD (hip) Measurement', 'timeFrame': 'Baseline, Month 6, Month 12'}, {'measure': 'QCT-acquired Compartmental Volumetric BMD (Spine) Measurement', 'timeFrame': 'Baseline, Month 6, Month 12'}, {'measure': 'QCT-acquired Cortical Thickness (Hip) Measurement', 'timeFrame': 'Baseline, Month 6, Month 12'}, {'measure': 'QCT-acquired Finite Element (FE) Strength (Hip) Measurement', 'timeFrame': 'Baseline, Month 6, Month 12'}, {'measure': 'QCT-acquired Mid-Thigh Cross-Sectional Area (CSA) Measurement', 'timeFrame': 'Baseline, Month 6, Month 12'}, {'measure': 'QCT-acquired Trunk Muscle Cross-Sectional Area (CSA) Measurement', 'timeFrame': 'Baseline, Month 6, Month 12'}, {'measure': 'QCT-acquired Thigh Muscle Density Measurement', 'timeFrame': 'Baseline, Month 6, Month 12'}, {'measure': 'QCT-acquired Thigh Fat Infiltration Measurement', 'timeFrame': 'Baseline, Month 6, Month 12'}, {'measure': 'Physical Function Measurement (Fast Walk)', 'timeFrame': 'Baseline, Month 6, Month 12', 'description': 'Fast-paced gait speed will be assessed using the fast 400 meter walk test. Participants will be asked to walk 10 laps of a 40 meter course (20 meters out and 20 meters back) as fast as possible and are given a maximum of 15 minutes to complete the test.'}, {'measure': 'Physical Function Measurement (Stair Climb)', 'timeFrame': 'Baseline, Month 6, Month 12', 'description': "Stair climbing ability will be assessed by using the participant's fastest time achieved to climb 12 steps in two trials. Both tests are sensitive to intensive weight loss and predictive of fall risk."}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bariatric surgery', 'bisphosphonate', 'mitigate bone loss'], 'conditions': ['Bone Loss']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to see whether receiving a bisphosphonate medication called risedronate can reduce bone and muscle loss following bariatric surgery. Participation will involve up to 6 study visits and last about 1 year. Risedronate is a medication that prevents bone breakdown and has been approved by the US Food and Drug Administration (FDA) for the prevention and treatment of osteoporosis in older men and women. However, risedronate has not been approved for the prevention of bone and muscle loss following vertical sleeve gastrectomy.\n\nParticipation in this study will involve completing two visits before beginning the intervention. Participants who qualify will be scheduled to begin the intervention program which will involve taking 6 monthly doses of a risedronate or placebo pill. Participants will then receive monthly contacts by study staff during this time to remind participants to take the intervention pill and ask about any adverse events. After the completion of intervention period, participants will complete up to 4 follow up study visits at 6 months (2 visits) and at 12 months (2 visits).', 'detailedDescription': 'The main objective of the proposed study is to definitively test whether risedronate use can effectively counter SG associated bone loss. To do this, we propose to randomize 120 middle-aged and older (≥40 years) SG patients to six months of risedronate or placebo treatment, with musculoskeletal outcomes assessed at baseline, six, and 12 months. Due to its robust change following SG and clinical utility in predicting fracture, our primary outcome is change in total hip areal (a)BMD measured by dual energy x-ray absorptiometry (DXA). This will be complemented by DXA-acquired aBMD assessment at other skeletal sites and appendicular lean mass, as well as quantitative computed tomography (QCT) derived changes in bone (volumetric BMD, cortical thickness, and strength) and muscle (cross sectional area, fat infiltration) at the hip and spine, and high-resolution peripheral quantitative computed tomography (HR-pQCT) derived changes in bone microarchitecture, density, and strength at the tibia and radius - allowing for novel assessment of intervention effectiveness on several state-of-the-art bioimaging metrics. Select measures of muscle function (fast 400-m walk, stair climb, knee extensor strength) are also included as proxies of fall risk. Finally, biomarkers of bone turnover (CTX, P1NP), bone-muscle crosstalk (TGF-β, RANKL, myostatin), and gut hormones (ghrelin, PYY, GLP-1) will be assessed in a tertiary aim, providing mechanistic insight into intervention-related changes to the bone-muscle unit. Thus, we aim to:\n\nAim 1: Determine the effect of risedronate compared to placebo on 12-month change from baseline in total hip aBMD following SG. We hypothesize that participants assigned to risedronate will better preserve total hip aBMD than participants assigned to placebo.\n\nAim 2: Determine the effects of risedronate compared to placebo on 12-month change from baseline in DXA-acquired aBMD at additional skeletal sites (femoral neck, lumbar spine, distal radius) and appendicular lean mass; QCT-derived measures of bone (volumetric BMD, cortical thickness, and strength) and muscle (cross sectional area, density, fat infiltration) at the hip and spine; HR-pQCT derived measures of bone microarchitecture, density, and strength at the tibia and radius; and muscle function (fast 400-m walk, stair climb, knee extensor strength) following SG. We hypothesize that participants assigned to risedronate will yield greater preservation/improvement in all secondary metrics than participants assigned to placebo.\n\nAim 3: Investigate the impact of treatment group assignment on biomarkers of bone turnover, bone-muscle crosstalk, and gut hormones to elucidate mechanisms underlying change in bone and muscle quantity and quality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who have had sleeve gastrectomy\n* Willing to provide informed consent\n* Agree to all study procedures and assessments.\n\nExclusion Criteria:\n\n* Weight greater than 450 lbs\n* Regular use of growth hormones, oral steroids, or prescription osteoporosis medications;\n* Known allergies to bisphosphonates\n* Unstable gastric reflux requiring two or more additional doses per month of anti-reflux medication.\n* Current participation in other research study\n* Unable to provide own transportation to study visits\n* Unable to position on scanner independently.'}, 'identificationModule': {'nctId': 'NCT04922333', 'briefTitle': 'Bisphosphonate Use to Mitigate Bone Loss Secondary to Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Bisphosphonate Use to Mitigate Bone Loss Secondary to Bariatric Surgery', 'orgStudyIdInfo': {'id': 'IRB00074763'}, 'secondaryIdInfos': [{'id': 'U01AR080969', 'link': 'https://reporter.nih.gov/quickSearch/U01AR080969', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bisphosphonate', 'description': 'Participants in this arm will receive six months of 150 mg once monthly oral risedronate', 'interventionNames': ['Drug: Risedronate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants in this arm will receive six months of placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Risedronate', 'type': 'DRUG', 'otherNames': ['Actonel', 'Atelvia'], 'description': '150mg over-encapsulated risedronate', 'armGroupLabels': ['Bisphosphonate']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Capsules containing placebo tablets', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kristen Beavers, PhD, MPH, RD', 'role': 'CONTACT', 'email': 'beaverkm@wfu.edu', 'phone': '336-758-5855'}, {'name': 'Lori Cogdill, MS', 'role': 'CONTACT', 'email': 'Lori.Cogdill@Advocatehealth.org', 'phone': '336-758-5044'}, {'name': 'Kristen Beavers, PhD, MPH, RD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Wake Forest School of Medicine', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'centralContacts': [{'name': 'Kristen Beavers, PhD, MPH, RD', 'role': 'CONTACT', 'email': 'beaverkm@wfu.edu', 'phone': '336-758-5855'}], 'overallOfficials': [{'name': 'Kristen Beavers, PhD, MPH, RD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}, {'name': 'Jamy Ard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}