Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-31 @ 2:37 PM
Study NCT ID:
NCT01803360
Status:
UNKNOWN
Last Update Posted:
2013-03-14
First Post:
2013-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of Neridronate to Treat Painful Osteoarthritis of the Knee With Bone Marrow Lesions.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C053389', 'term': '6-amino-1-hydroxyhexane-1,1-diphosphonate'}]}}, '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': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-03-13', 'studyFirstSubmitDate': '2013-03-01', 'studyFirstSubmitQcDate': '2013-03-01', 'lastUpdatePostDateStruct': {'date': '2013-03-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'knee pain reduction', 'timeFrame': '60 days', 'description': 'to assess the efficacy in terms of proportion of patients with a 50% reduction in pain intensity compared to baseline measured by VAS 100 mm scale recorded at the last visit (day 60)'}], 'secondaryOutcomes': [{'measure': 'Bone marrow lesions reduction', 'timeFrame': '60 days'}]}, 'conditionsModule': {'conditions': ['Osteoarthritis, Knee']}, 'referencesModule': {'references': [{'pmid': '25998450', 'type': 'DERIVED', 'citation': 'Varenna M, Zucchi F, Failoni S, Becciolini A, Berruto M. Intravenous neridronate in the treatment of acute painful knee osteoarthritis: a randomized controlled study. Rheumatology (Oxford). 2015 Oct;54(10):1826-32. doi: 10.1093/rheumatology/kev123. Epub 2015 May 20.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether neridronate is effective in the treatment of pain related to bone marrow oedema in patients with osteoarthritis of the knee.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of knee Osteoarthritis (ACR criteria)\n* Radiographic diagnosis of knee Osteoarthritis (Kellgren/Lawrence scale \\>=2)\n* \\>4 weeks but \\<3 months pain, reported as \\>30 mm on a 100 mm VAS scale\n* bone marrow oedema of the affected knee on magnetic resonance\n\nExclusion Criteria:\n\n* inflammatory arthritis\n* aseptic osteonecrosis of the knee\n* previous or current treatment with Bisphosphonates\n* serum calcium or creatinine abnormalities'}, 'identificationModule': {'nctId': 'NCT01803360', 'briefTitle': 'Efficacy Study of Neridronate to Treat Painful Osteoarthritis of the Knee With Bone Marrow Lesions.', 'organization': {'class': 'OTHER', 'fullName': 'ASST Gaetano Pini-CTO'}, 'officialTitle': 'A Randomized, Double-blind, Placebo Controlled Trial to Assess the Efficacy of Neridronate 100 mg -4 i.v. Infusions- in Patients With Painful Osteoarthritis of the Knee With Bone Marrow Lesions.', 'orgStudyIdInfo': {'id': 'NERI-OA-2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neridronate', 'description': 'Neridronate 100 mg solution for infusion: 4 intravenous administrations in a course of 10 days treatment', 'interventionNames': ['Drug: Neridronate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Saline solution for infusion: 4 intravenous administrations in a course of 10 days treatment'}], 'interventions': [{'name': 'Neridronate', 'type': 'DRUG', 'description': 'Neridronate 100 mg solution for infusion: 4 intravenous administrations in a course of 10 days treatment', 'armGroupLabels': ['Neridronate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20122', 'city': 'Milan', 'state': 'MI', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Massimo Varenna', 'role': 'CONTACT', 'email': 'varenna@gpini.it', 'phone': '00390258296897'}, {'name': 'Massimo Varenna', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Istituto Ortopedico Gaetano Pini', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'centralContacts': [{'name': 'Massimo Varenna', 'role': 'CONTACT', 'email': 'varenna@gpini.it', 'phone': '00390258296897'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ASST Gaetano Pini-CTO', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Massimo Varenna', 'investigatorAffiliation': 'ASST Gaetano Pini-CTO'}}}}