Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-29 @ 7:25 PM
Study NCT ID:
NCT01935804
Status:
COMPLETED
Last Update Posted:
2014-06-17
First Post:
2013-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Pioglitazone Versus Metformin on Bone Health in Postmenopausal Women With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}], 'ancestors': [{'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077205', 'term': 'Pioglitazone'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 440}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-16', 'studyFirstSubmitDate': '2013-08-27', 'studyFirstSubmitQcDate': '2013-09-02', 'lastUpdatePostDateStruct': {'date': '2014-06-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exploratory and Safety Outcomes', 'timeFrame': '6-18 months', 'description': 'Other endpoints were changes in inflammatory markers (hs-CRP)'}, {'measure': 'Exploratory Outcomes: lipid profile', 'timeFrame': '6-18 months', 'description': 'lipid profile (total cholesterol, HDL-c, LDL-c and triglycerides)'}, {'measure': 'Exploratory outcomes: liver and renal function tests', 'timeFrame': '6-18 months', 'description': 'liver function tests \\[albumin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP)\\]; renal function tests (creatinine, urea, uric acid) and parathyroid hormone (PTH).'}, {'measure': 'Exploratory outcomes: glycemic control', 'timeFrame': '6-18 months', 'description': 'within and between treatment group comparisons of change from baseline at specified time points in HbA1c, fasting plasma glucose (FPG), fasting plasma insulin, and insulin sensitivity measured by the homeostasis model assessment (HOMA-s).'}, {'measure': 'Exploratory and safety outcomes', 'timeFrame': '6-18 months', 'description': 'Safety endpoints were adverse events (AEs), clinical laboratory assessments, vital signs, and electrocardiograms'}], 'primaryOutcomes': [{'measure': 'Change in mean percentage change in BMD at various sites by Dual energy X-ray absorptiometry(DXA) from baseline and at 6, 12 months in PIO versus MET treatment group.', 'timeFrame': '6-18 months', 'description': 'The primary endpoint was change in mean percentage change in BMD values at the lumbar spine (L1-L4), femoral neck and total hip by DXA from baseline and at 6 and 12 months in the PIO and the MET treatment groups.'}], 'secondaryOutcomes': [{'measure': 'Bone turnover Markers and other Biomarkers', 'timeFrame': '6-18 months', 'description': 'Secondary end-points were changes in serum sclerostin, serum bone-specific alkaline phosphatase (BSAP), serum procollagen type1 N-terminal propeptide (P1NP) and serum C-terminal crosslinking telopeptide of type 1 collagen (CTX); and urinary N-terminal crosslinking telopeptide type 1 collagen (u-NTX); serum calcium, 25-hydroxyvitamin D (25-OHD), and serum Dickkopf-1( DKK-1) at various time intervals from baseline between PIO vs MET treatment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pioglitazone', 'metformin', 'hyperglycemic agents', 'physiological effects of drugs', 'bone health'], 'conditions': ['Diabetes Mellitus', 'Diabetes Mellitus, Type 2', 'Glucose Metabolism Disorders']}, 'descriptionModule': {'briefSummary': 'The study tests whether pioglitazone (PIO)as compared to metformin (MET)affects bone health including bone mineral density, bone turnover markers, and osteocyte biomarker in patients with type 2 diabetes (T2DM).', 'detailedDescription': 'Women with T2DM exhibit normal or higher bone mineral density (BMD) for their age, but with approximately twice the overall risk of bone fragility compared with nondiabetic subjects. Known the apparent association between T2DM and the risk of bone fragility, examining the effects of commonly used oral antidiabetic agents; such as MET and thiazolidinediones (TZDs; for example rosiglitazone \\[ROS\\] or PIO), on BMD and/or bone turnover is of great clinical relevance for both diabetic patients and their treating physicians. Recent clinical trials, showed that women treated with ROS had higher risk of bone fragility and self-reported adverse events. Similarly, women on long-term treatment with PIO for T2DM experienced higher incidence of distal extremity fractures. TZDs are agonists of the nuclear transcription factor peroxisome proliferator- activated receptor-γ (PPAR-γ) which increase insulin sensitivity and improve glycemic control in T2DM. PPAR (γ) acts also as a molecular factor that favours adipogenesis over osteoblastogenesis of mesenchymal stem cells. The latter was suggested as a potential mechanism for the effects of TZDs on bone among others. In humans, TZDs decrease BMD and increase bone fragility risk. This study tests whether pioglitazone as compared to MET (both are commonly used in the treatment of T2DM in Saudi Arabia and other countries) affects bone health including bone mineral density, bone turnover markers, and osteocyte biomarker in patients with T2DM.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMD T-score greater than -2.5 at the total hip, femoral neck, and lumbar spine;\n* No prior antidiabetic therapy;\n* Drug-naïve with glycosylated hemoglobin A1c (HbA1c) ≥ 7.0 to ≤ 10.0%. 53.2 mmol/mol to 88.2 mmol/mol);\n* Body-mass index of 40 Kg/m2 and less;\n* Stable body weight for at least 4 months.\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus (presence of GAD auto antibodies);\n* History of diabetes or uncontrolled hypertension;\n* Treatment with antidiabetic agents including TZDs;\n* Chronic diseases known to affect bone;\n* Previous treatment with estrogens and other medications known to affect bone ;\n* Creatinine clearance less than 60 ml/min'}, 'identificationModule': {'nctId': 'NCT01935804', 'acronym': 'Pioglitazone', 'briefTitle': 'Effect of Pioglitazone Versus Metformin on Bone Health in Postmenopausal Women With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'King Abdulaziz University'}, 'officialTitle': 'Phase 1 Study of Pioglitazone Versus Metformin on Bone Health in Postmenopausal Women With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'CEOR-01-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: 1', 'description': 'Pioglitazone given 30mg/once daily for 12 months.', 'interventionNames': ['Drug: Pioglitazone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active comparator: 2', 'description': 'Metformin given 850 mg/twice daily for 12 months.', 'interventionNames': ['Drug: Metformin']}], 'interventions': [{'name': 'Pioglitazone', 'type': 'DRUG', 'otherNames': ['Actos'], 'description': '30 mg/daily for 12 months', 'armGroupLabels': ['Experimental: 1']}, {'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['Glucophage'], 'description': '850 mg/daily for 12 months', 'armGroupLabels': ['Active comparator: 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21589', 'city': 'Jeddah', 'state': 'Mecca Region', 'country': 'Saudi Arabia', 'facility': 'Center of Excellence for Osteoporosis Research, King Abdulaziz University', 'geoPoint': {'lat': 21.49012, 'lon': 39.18624}}], 'overallOfficials': [{'name': 'Mohammed-Salleh M Ardawi, PhD, FRCPath', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center of Excellence for Osteoporosis Research and Faculty of Medicine, King Abdulaziz University'}, {'name': 'Abdulrahim A Rouzi, FRCPC', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Center of Excellence for Osteoporosis Research, and Faculty of Medicine, King Abdulaziz University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Abdulaziz University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mohammed-Salleh M. Ardawi', 'investigatorAffiliation': 'King Abdulaziz University'}}}}