Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-25 @ 8:58 PM
Study NCT ID:
NCT00144456
Status:
COMPLETED
Last Update Posted:
2013-08-09
First Post:
2005-09-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A New Active Vitamin D, ED-71 for Osteoporosis
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': 'C547512', 'term': 'eldecalcitol'}, {'id': 'C008088', 'term': 'alfacalcidol'}]}}, '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': 1056}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-06', 'studyFirstSubmitDate': '2005-09-02', 'studyFirstSubmitQcDate': '2005-09-02', 'lastUpdatePostDateStruct': {'date': '2013-08-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidences of vertebral fracture', 'timeFrame': 'throughout study'}], 'secondaryOutcomes': [{'measure': 'Changes of Lumbar Spine and total hip bone mineral density', 'timeFrame': 'throughout study'}]}, 'conditionsModule': {'conditions': ['Osteoporosis']}, 'referencesModule': {'references': [{'pmid': '22794117', 'type': 'DERIVED', 'citation': 'Shiraki M, Saito H, Matsumoto T. Eldecalcitol normalizes bone turnover markers regardless of their pre-treatment levels. Curr Med Res Opin. 2012 Sep;28(9):1547-52. doi: 10.1185/03007995.2012.712506. Epub 2012 Aug 23.'}, {'pmid': '21784190', 'type': 'DERIVED', 'citation': 'Matsumoto T, Ito M, Hayashi Y, Hirota T, Tanigawara Y, Sone T, Fukunaga M, Shiraki M, Nakamura T. A new active vitamin D3 analog, eldecalcitol, prevents the risk of osteoporotic fractures--a randomized, active comparator, double-blind study. Bone. 2011 Oct;49(4):605-12. doi: 10.1016/j.bone.2011.07.011. Epub 2011 Jul 19.'}]}, 'descriptionModule': {'briefSummary': 'A prospective, randomized, double-blind study to compare the effect of ED-71 with that of alfacalcidol on fracture incidence'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Osteoporotic patients who meet any of the following condition:\n\n 1. with at least one fragility fracture,\n 2. above 70 year-old with bone mineral density below 70% young adult mean,\n 3. with bone mineral density below 60% young adult mean\n* Women three years or more after menopause or men\n\nExclusion Criteria:\n\n* Current disorders such as primary hyperparathyroidism, Cushing's syndrome,gonadal insufficiency, poorly controlled diabetes mellitus or other causes of secondary osteoporosis\n* A history or suspicion of active urolithiasis at any time\n* Use of bisphosphonates in the past 12 months\n* Use of medications known to affect bone in the past 2 months\n* Abnormal serum calcium, urinary calcium, serum creatinine or liver function tests"}, 'identificationModule': {'nctId': 'NCT00144456', 'briefTitle': 'A New Active Vitamin D, ED-71 for Osteoporosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chugai Pharmaceutical'}, 'officialTitle': 'A Prospective, Randomized, Double-blind Study to Compare the Effect of ED-71 With That of Alfacalcidol on Fracture Incidence in Osteoporotic Patients', 'orgStudyIdInfo': {'id': 'ED-209JP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: ED-71', 'Drug: Alfacalcidol placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Alfacalcidol', 'Drug: ED-71 placebo']}], 'interventions': [{'name': 'ED-71', 'type': 'DRUG', 'description': '0.75μg/day(p.o.)for 144 weeks', 'armGroupLabels': ['1']}, {'name': 'Alfacalcidol', 'type': 'DRUG', 'description': '1.0μg/day(p.o.)for 144 weeks', 'armGroupLabels': ['2']}, {'name': 'ED-71 placebo', 'type': 'DRUG', 'description': '0 μg/day(p.o.)for 144 weeks', 'armGroupLabels': ['2']}, {'name': 'Alfacalcidol placebo', 'type': 'DRUG', 'description': '0 μg/day(p.o.)for 144 weeks', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Toshio Matsumoto, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Medicine and Bioregulatory Sciences, Universitof Tokushima Graduate School of Health Bioscience'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chugai Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}