Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2026-04-22 @ 8:21 AM
Study NCT ID:
NCT05266261
Status:
COMPLETED
Last Update Posted:
2022-03-04
First Post:
2022-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Ibandronate in Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015663', 'term': 'Osteoporosis, Postmenopausal'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077557', 'term': 'Ibandronic Acid'}, {'id': 'D002119', 'term': 'Calcium Carbonate'}, {'id': 'D002762', 'term': 'Cholecalciferol'}], 'ancestors': [{'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D017610', 'term': 'Calcium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D002254', 'term': 'Carbonates'}, {'id': 'D002255', 'term': 'Carbonic Acid'}, {'id': 'D017554', 'term': 'Carbon Compounds, Inorganic'}, {'id': 'D008903', 'term': 'Minerals'}, {'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-02', 'studyFirstSubmitDate': '2022-02-20', 'studyFirstSubmitQcDate': '2022-03-02', 'lastUpdatePostDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone mineral density', 'timeFrame': '1 year', 'description': '. Percentage change in dual-energy X-ray absorptiometry (DXA) bone mineral density (BMD) at the lumbar spine, total hip, and femoral neck, presented as least square mean and 95% confidence interval.'}], 'secondaryOutcomes': [{'measure': 'Bone turnover markers', 'timeFrame': '6 month and 12 month', 'description': 'Percentage change in bone turnover markers \\[Serum C-telopeptide (CTx) and procollagen type 1 N-terminal propeptide (P1NP) levels were measured by immunoassay methods using Elecsys kits - 07296355001V4 and 07296509001V4 (Roche Diagnostic Corp., Basel, Switzerland) \\] presented as adjusted mean and 95% confidence interval using the generalized estimating equations for repeated measures analysis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoporosis, Postmenopausal', 'Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '35410197', 'type': 'DERIVED', 'citation': 'Kim J, Kim KM, Lim S, Kang MI, Baek KH, Min YK. Efficacy of bisphosphonate therapy on postmenopausal osteoporotic women with and without diabetes: a prospective trial. BMC Endocr Disord. 2022 Apr 11;22(1):99. doi: 10.1186/s12902-022-01010-w.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine whether monthly oral administration of ibandronate to postmenopausal osteoporosis patients with type 2 diabetes differs in safety and efficacy compared to patients without diabetes.', 'detailedDescription': 'There are two major considerations in the use of bisphosphonates in diabetic patients.\n\n* The low rate of bone turnover in diabetic patients is at risk of side effects such as excessive inhibition of bone turnover associated with the use of bisphosphonates.\n* A decrease in osteocalcin following bisphosphonate use may lead to deterioration of glucose metabolism.\n\nThe efficacy of ibandronate in T2DM is not thought to be significantly different based on previous studies, but there is few study on ibandronate.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age of at least 55 years at the time of screening\n* postmenopausal woman\n* diagnosis of osteoporosis\n\nExclusion Criteria:\n\n* history of osteoporosis treatment\n* underlying disease (e.g., heart failure, liver disease, renal disease, or malignancy)\n* the use of drugs that affect bone metabolism (e.g., steroids, immunosuppressants, gonadotropin-releasing hormone agonists, aromatase inhibitors, thiazolidinedione drugs, anticonvulsants, and antidepressants)\n* history of adverse effects of bisphosphonate or difficulty taking the drug due to an inability to sit or the presence of upper gastrointestinal disease'}, 'identificationModule': {'nctId': 'NCT05266261', 'briefTitle': 'Use of Ibandronate in Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': "Yeouido St. Mary's Hospital"}, 'officialTitle': 'Efficacy of Bisphosphonate Therapy on Postmenopausal Osteoporotic Women With and Without Diabetes: a Prospective Trial', 'orgStudyIdInfo': {'id': 'SC18MEDV0024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Non-diabetes', 'description': 'postmenopausal women with normal glucose tolerance', 'interventionNames': ['Drug: Ibandronate Oral Tablet']}, {'type': 'EXPERIMENTAL', 'label': 'diabetes', 'description': 'postmenopausal women with type 2 diabetes', 'interventionNames': ['Drug: Ibandronate Oral Tablet']}], 'interventions': [{'name': 'Ibandronate Oral Tablet', 'type': 'DRUG', 'otherNames': ['daily oral formulation of 1,250 mg of calcium carbonate + 1,000 IU of cholecalciferol'], 'description': '150 mg of ibandronate + 24,000 IU of cholecalciferol', 'armGroupLabels': ['Non-diabetes', 'diabetes']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': "Yeouido St.Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Ki-Hyun Baek, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Yeouido St. Mary's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data that support the findings of this study are available from the corresponding author upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Yeouido St. Mary's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Samsung Medical Center', 'class': 'OTHER'}, {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}