Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2026-01-01 @ 4:08 AM
Study NCT ID:
NCT01063504
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2010-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Teriparatide for Improved Knee Prosthesis Fixation
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': 'D019379', 'term': 'Teriparatide'}], 'ancestors': [{'id': 'D010281', 'term': 'Parathyroid Hormone'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-17', 'studyFirstSubmitDate': '2010-02-04', 'studyFirstSubmitQcDate': '2010-02-04', 'lastUpdatePostDateStruct': {'date': '2013-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Migration as measured by RSA maximal total point motion.', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Osteoarthritis of the Knee']}, 'descriptionModule': {'briefSummary': 'The investigators will study how well knee joint prostheses become fixed to the bone when patients get teriparatide, compared to placebo. Measurements will use high resolution 3D radiography (radiostereometry, RSA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Osteoarthritis of the knee planned for prosthesis surgery\n\nExclusion Criteria:\n\n* Poor health, drugs affecting bone metabolism.'}, 'identificationModule': {'nctId': 'NCT01063504', 'briefTitle': 'Teriparatide for Improved Knee Prosthesis Fixation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Linkoeping'}, 'orgStudyIdInfo': {'id': 'PTHKnee'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Teriparatide 20 microgram daily for 2 months', 'interventionNames': ['Drug: teriparatide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: teriparatide']}], 'interventions': [{'name': 'teriparatide', 'type': 'DRUG', 'armGroupLabels': ['Placebo', 'Teriparatide 20 microgram daily for 2 months']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Motala', 'country': 'Sweden', 'facility': 'Motala hospital', 'geoPoint': {'lat': 58.53706, 'lon': 15.03649}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Linkoeping', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Per Aspenberg', 'investigatorAffiliation': 'University Hospital, Linkoeping'}}}}