Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-03-02 @ 4:00 PM
Study NCT ID:
NCT02066805
Status:
COMPLETED
Last Update Posted:
2015-05-29
First Post:
2014-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Estimation of Off-Label Use of XGEVA® (Denosumab) Using Population-Based Databases in Denmark
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-27', 'studyFirstSubmitDate': '2014-02-13', 'studyFirstSubmitQcDate': '2014-02-19', 'lastUpdatePostDateStruct': {'date': '2015-05-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'on or off label individual prescription type', 'timeFrame': '12 months', 'description': 'Yes/no regarding whether an individual prescription was on (or off) label'}, {'measure': 'on or off label patient treatment', 'timeFrame': '12 months', 'description': 'Yes/no regarding whether the patient was treated on (or off) label'}], 'secondaryOutcomes': [{'measure': 'type of off-label use', 'timeFrame': '12 months', 'description': 'XGEVA prescription for each type of off-label use'}, {'measure': 'off-label use stratified by administering department', 'timeFrame': '12 months', 'description': 'Prescriptions that are for off-label use stratified by department that administers treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['XGEVA Off-label Use']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate off-label XGEVA use in Denmark using data linked from registries and other sources in Northern Jutland Region and Copenhagen. This will allow for accurate assessment of prescriptions and diagnoses, especially those related to cancer patients during the first year post the initial market availability of XGEVA.'}, 'eligibilityModule': {'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include 108-200 patients who receive a prescription in secondary care of XGEVA during the first year after the initial market availability. These patients will be identified from the Danish National Registry of Patients and other sources in the Northern Jutland Region and Copenhagen.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe study will include patients with a prescription for XGEVA® given in secondary care with a minimum of 108 XGEVA users, in the Northern Jutland Region and Copenhagen during the first 1-year post XGEVA market availability, defined as 12 months after RADS opinion on 24th January 2013 or after the minimum sample has been achieved.\n\nExclusion Criteria:\n\nn/a'}, 'identificationModule': {'nctId': 'NCT02066805', 'briefTitle': 'Estimation of Off-Label Use of XGEVA® (Denosumab) Using Population-Based Databases in Denmark', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'Estimation of Off-Label Use of XGEVA® (Denosumab) Using Population-Based Databases in Denmark', 'orgStudyIdInfo': {'id': '20101335'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'interventionNames': ['Drug: Database assessment of off-label XGEVA use']}], 'interventions': [{'name': 'Database assessment of off-label XGEVA use', 'type': 'DRUG', 'description': 'No intervention is planned during this study as it involves analyses of patient electronic records from Northern Jutland Region and Copenhagen', 'armGroupLabels': ['Cohort 1']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Aarhus', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}