Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-03-11 @ 9:13 PM
Study NCT ID:
NCT00486369
Status:
COMPLETED
Last Update Posted:
2007-06-14
First Post:
2007-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SMC021A - Absorption, Efficacy and Tolerance in Patients With Osteoarthritis. A Placebo-Controlled 14-Days Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C028815', 'term': 'salmon calcitonin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-06', 'lastUpdateSubmitDate': '2007-06-13', 'studyFirstSubmitDate': '2007-06-13', 'studyFirstSubmitQcDate': '2007-06-13', 'lastUpdatePostDateStruct': {'date': '2007-06-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'secondaryOutcomes': [{'measure': 'Changes in Urine CTX-I and CTX-II'}, {'measure': 'Changes in serum osteocalcin and serum CTX-I'}, {'measure': 'Number of adverse events'}]}, 'conditionsModule': {'keywords': ['Osteoarthritis, oral salmon calcitonin, tolerability, biomarkers'], 'conditions': ['Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '20565725', 'type': 'DERIVED', 'citation': 'Karsdal MA, Byrjalsen I, Bay-Jensen AC, Henriksen K, Riis BJ, Christiansen C. Biochemical markers identify influences on bone and cartilage degradation in osteoarthritis--the effect of sex, Kellgren-Lawrence (KL) score, body mass index (BMI), oral salmon calcitonin (sCT) treatment and diurnal variation. BMC Musculoskelet Disord. 2010 Jun 17;11:125. doi: 10.1186/1471-2474-11-125.'}, {'pmid': '19747581', 'type': 'DERIVED', 'citation': 'Karsdal MA, Byrjalsen I, Henriksen K, Riis BJ, Lau EM, Arnold M, Christiansen C. The effect of oral salmon calcitonin delivered with 5-CNAC on bone and cartilage degradation in osteoarthritic patients: a 14-day randomized study. Osteoarthritis Cartilage. 2010 Feb;18(2):150-9. doi: 10.1016/j.joca.2009.08.004. Epub 2009 Sep 1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to expose patients with OA to calcitonin and to determine plasma calcitonin levels after administration of 0.6 mg and 0.8 mg oral calcitonin. Also the purpose is to assess the effect of different doses of oral calcitonin (0.6 mg and 0.8 mg oral) compared to placebo on serum CTX-I and CTX-II. Finally to assess the tolerance profile of different doses/formulations of oral calcitonin compared to placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '52 Years', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Medical history and symptoms of knee osteoarthritis\n\nExclusion Criteria:\n\n* Any other disease or medication affecting the bone or cartilage.\n* Any clinical signs or laboratory evidence diseases, which in the Investigator's opinion would preclude the participant from adhering to the Protocol or completing the trial."}, 'identificationModule': {'nctId': 'NCT00486369', 'briefTitle': 'SMC021A - Absorption, Efficacy and Tolerance in Patients With Osteoarthritis. A Placebo-Controlled 14-Days Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nordic Bioscience A/S'}, 'officialTitle': 'SMC021A - Absorption, Efficacy and Tolerance in Patients With Osteoarthritis. A Placebo-Controlled 14-Days Study.', 'orgStudyIdInfo': {'id': 'CSMC021C2102'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Oral salmon calcitonin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2750', 'city': 'Ballerup Municipality', 'country': 'Denmark', 'facility': 'CCBR A/S', 'geoPoint': {'lat': 55.73165, 'lon': 12.36328}}], 'overallOfficials': [{'name': 'Bente J Riis, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Nordic Bioscience A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nordic Bioscience A/S', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Novartis', 'class': 'INDUSTRY'}]}}}