Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-04-11 @ 4:33 AM
Study NCT ID:
NCT01581320
Status:
COMPLETED
Last Update Posted:
2016-11-01
First Post:
2012-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase III Clinical Trial of DP-R206 and Bonvia In Postmenopausal Women With Osteoporosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000592733', 'term': 'DP-R206'}, {'id': 'D004341', 'term': 'Drug Evaluation'}, {'id': 'D000077557', 'term': 'Ibandronic Acid'}, {'id': 'D002762', 'term': 'Cholecalciferol'}], 'ancestors': [{'id': 'D000076722', 'term': 'Drug Development'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005069', 'term': 'Evaluation Studies as Topic'}, {'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 201}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-31', 'studyFirstSubmitDate': '2012-02-26', 'studyFirstSubmitQcDate': '2012-04-18', 'lastUpdatePostDateStruct': {'date': '2016-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A ratio of subject whose 25 OHD concentration is less than 15ng/mL', 'timeFrame': '16weeks', 'description': 'A ratio of subject whose 25 OHD concentration is less than 15ng/mL after 16weeks'}], 'secondaryOutcomes': [{'measure': 'A ratio of subject whose 25 OHD concentration is less than 9ng/mL', 'timeFrame': '16 weeks', 'description': 'A ratio of subject whose 25 OHD concentration is less than 9ng/mL after 16weeks'}, {'measure': 'Safety evaluation (AE, Lab test, Vital sign etc)', 'timeFrame': '16weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Postmenopausal Women With Osteoporosis']}, 'descriptionModule': {'briefSummary': 'A multicenter, randomized, double-blind, active-controlled, phase III clinical trial to evaluate the efficacy and safety of Dp-R206 and Bonviva for 16 weeks once a month on the improvement of vitamin D in postmenopausal women with osteoporosis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female more than 40 years old in postmenopausal\n\nExclusion Criteria:\n\n* Subject who has a history of malignant cancer'}, 'identificationModule': {'nctId': 'NCT01581320', 'acronym': 'DIOS', 'briefTitle': 'Phase III Clinical Trial of DP-R206 and Bonvia In Postmenopausal Women With Osteoporosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alvogen Korea'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R206 and Bonviva for the Improvement of Vitamin D in Postmenopausal Women With Osteoporosis', 'orgStudyIdInfo': {'id': 'DP-CTR206-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DP-R206', 'interventionNames': ['Drug: Test group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bonviva', 'interventionNames': ['Drug: Reference group']}], 'interventions': [{'name': 'Test group', 'type': 'DRUG', 'otherNames': ['DP-R206 (Test drug)', '<Ibandronate 150mg + cholecalciferol(Vitamin D3) 24,000IU>'], 'description': 'Once a month, administration of DP-R206 \\& placebo for 16 weeks', 'armGroupLabels': ['DP-R206']}, {'name': 'Reference group', 'type': 'DRUG', 'otherNames': ['Bonviva®', '(Ibandronate 150mg)'], 'description': 'Once a month, administration of Bonviva \\& placebo for 16 weeks', 'armGroupLabels': ['Bonviva']}]}, 'contactsLocationsModule': {'locations': [{'zip': '137-701', 'city': 'Seoul', 'country': 'South Korea', 'facility': "The Catholic University of Korea Seoul St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Moo-il Kang, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'The Catholic University of Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alvogen Korea', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}