Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-02-09 @ 5:03 AM
Study NCT ID:
NCT02327650
Status:
UNKNOWN
Last Update Posted:
2021-09-21
First Post:
2014-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Examine Whether or Not the Primary Causes of OA or RA Might be Bone Alterations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-20', 'studyFirstSubmitDate': '2014-12-21', 'studyFirstSubmitQcDate': '2014-12-24', 'lastUpdatePostDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The bone signal changes detected by MRI in OA and/or RA patients', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Progression of Rheumatoid Arthritis', 'Osteoarthritis of Multiple Joints']}, 'descriptionModule': {'briefSummary': 'Generally, osteoarthris (OA) is considered as primarily cartilage disease. However, as we and others have previously reported, a portion of OA might be caused primarily by bone alterations. In this study, we prospectively and retrospectively show that the bone altertations may affect OA primarily in all of the joints.\n\nIn addition, rheumatoid arthritis (RA) is a joint disease when immune system attacks synovium. Joint destruction occurrs continuously if suitable treatment is not performed. The etiology of RA is still largely unknown. As with OA, RA can be primarily damaged in bone, instead of cartilage. Here we prospectively and retrospectively show that the bone altertations may affect RA primarily in all of the joints.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The patients who have OA with accompaying joint pain or the patients who have RA with accompaying joint pain', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* RA and/or OA\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT02327650', 'briefTitle': 'To Examine Whether or Not the Primary Causes of OA or RA Might be Bone Alterations', 'organization': {'class': 'OTHER', 'fullName': 'Shinshu University'}, 'officialTitle': 'The Examinations Whether or Not the Primary Causes of Osteoarthritis or Rheumatoid Arthritis in Joints Might be Bone Alterations', 'orgStudyIdInfo': {'id': 'OA RA Bone Study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'RA and OA', 'description': 'Every 2 or 3 months, plain radiograph, blood and urinary tests, and MRI are performed in the painful joints of RA.', 'interventionNames': ['Procedure: The examinations for bones in joints of OA and RA patients']}], 'interventions': [{'name': 'The examinations for bones in joints of OA and RA patients', 'type': 'PROCEDURE', 'armGroupLabels': ['RA and OA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3908621', 'city': 'Matsumoto', 'state': 'Nagano', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Yukio Nakamura, MD, PhD', 'role': 'CONTACT', 'email': 'yxn14@aol.jp', 'phone': '+81-263-37-2659'}, {'name': 'Yukio Nakamura, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Yukio Nakamura', 'geoPoint': {'lat': 36.23333, 'lon': 137.96667}}, {'city': 'Matsumoto', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Yukio Nakamura', 'role': 'CONTACT', 'email': 'yxn14@aol.jp'}], 'facility': 'Yukio Nakamura', 'geoPoint': {'lat': 36.23333, 'lon': 137.96667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shinshu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Yukio Nakamura', 'investigatorAffiliation': 'Shinshu University'}}}}