Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-01-04 @ 2:29 PM
Study NCT ID:
NCT01806792
Status:
COMPLETED
Last Update Posted:
2013-03-07
First Post:
2013-03-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-menopausal Women Osteoporosis(Phase III)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D002762', 'term': 'Cholecalciferol'}, {'id': 'D000068296', 'term': 'Risedronic Acid'}], 'ancestors': [{'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'}, {'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-06', 'studyFirstSubmitDate': '2013-03-05', 'studyFirstSubmitQcDate': '2013-03-06', 'lastUpdatePostDateStruct': {'date': '2013-03-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proportion of patients with 25(OH)D level < 20 ng/mL at 16 weeks.', 'timeFrame': '16 weeks form first drug adminstration.'}], 'secondaryOutcomes': [{'measure': 'proportion of patients with 25(OH)D level < 9 ng/mL at 16 weeks, change of 25(OH)D level and Bone Markers.', 'timeFrame': '16 weeks form first drug administration.', 'description': 'Secondary end point is :\n\n1. proportion of patients with 25(OH)D level \\< 9 ng/mL at 16 weeks\n2. change of 25(OH)D level\n3. change of BSAP\n4. change of CTX\n5. change of Ca\n6. change of phosphorous\n7. change of PTH\n8. change of 8-foot walking test, Sit-To-Stand test'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Osteoporosis'], 'conditions': ['Postmenopausal Women Osteoporosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and the safety of Risedronate, cholecalciferol combination tablet in patients with Osteoporosis', 'detailedDescription': 'The purpose of this study is to evaluate the efficacy and the safety of Monthly Risedronate with cholecalciferol on 25 Hydroxyvitamin D level and bone markers patients with osteoporosis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. women osteoporosis\n2. patients with a diagnosis of Postmenopausal over 6 Months if they had a bone mineral density T-score of \\< -2.5 at the mean lumbar spine (L1-4), femoral neck, or total, or a T-score of \\< -1.0 with radiologic evidence of at least one vertebral fracture. Menopause was defined as no natural menses for at least 1 year and a serum FSH level \\> 40 IU/L, with a reported hysterectomy\n3. low levels of 25(OH)D \\> 9 ng/mL\n4. patients who give written consent of agreement to voluntarily participate in the clinical study\n5. patients who can read and understand written instructions\n\nExclusion Criteria:\n\n1. patients who had contraindications to oral bisphosphonates, such as esophageal strictures\n2. ALT, AST ≥ 2×UNL and Serum Creatinine ≥ 1.5×UNL\n3. low levels of 25(OH)D (less than 9 ng/mL).\n4. Previous use of oral bisphosphonates and vitamin D were allowed, but a washout period was needed, depending on the duration of treatment. Two-year washout periods were needed for bisphosphonate users and 3-6-month periods were required for vitamin D users of \\> 200 IU.\n5. drug administration after diagnosing as alcoholic or psychical disease\n6. patients whom the investigators judge as improper to participate in this clinical trial 7)13.patients who have experience to participate in other clinical trial within 30 days prior to study participation'}, 'identificationModule': {'nctId': 'NCT01806792', 'briefTitle': 'Post-menopausal Women Osteoporosis(Phase III)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hanlim Pharm. Co., Ltd.'}, 'officialTitle': 'For 4 Months, the Multi Center, Double Blinded, Randomized, Active Controlled, Comparative Clinical Study to Assess the Efficacy and the Safety to Improvement Effect of Vit.D of Risenex Plus M Tablet in Patients With In Post-menopausal Women Osteoporosis', 'orgStudyIdInfo': {'id': 'HL_RSNPM_301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Risendronate and Cholecalciferol combination', 'description': 'risedronate 150mg and cholecalciferol 30,000 IU 1 tablet + Placebo(for risedronate 150mg) 1 tablet by once a month.', 'interventionNames': ['Drug: risedronate combine', 'Drug: Placebo(for Risedronate)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Risedronate', 'description': 'risedronate 150mg 1 tablet + Placebo(for risedronate 150mg and cholecalciferol 30,000 IU) 1 tablet by once a month.', 'interventionNames': ['Drug: Risedronate', 'Drug: Placebo(for risedronate combine)']}], 'interventions': [{'name': 'risedronate combine', 'type': 'DRUG', 'otherNames': ['- Other name : Risenex M(risedronate 150mg and cholecalciferol 30,000 IU combined)'], 'armGroupLabels': ['Risendronate and Cholecalciferol combination']}, {'name': 'Risedronate', 'type': 'DRUG', 'otherNames': ['Other name : Actonel(Risedronate 150mg)'], 'armGroupLabels': ['Risedronate']}, {'name': 'Placebo(for Risedronate)', 'type': 'DRUG', 'otherNames': ['once a month'], 'armGroupLabels': ['Risendronate and Cholecalciferol combination']}, {'name': 'Placebo(for risedronate combine)', 'type': 'DRUG', 'otherNames': ['once a month'], 'armGroupLabels': ['Risedronate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '156-755', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Chung-ang university hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Hyoung-Moo Park, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chung-Ang University Hosptial, Chung-Ang University College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanlim Pharm. Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}