Ignite Creation Date:
2025-12-24 @ 9:39 PM
Ignite Modification Date:
2026-02-21 @ 3:30 PM
Study NCT ID:
NCT00994032
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
2009-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life After Vertebroplasty Versus Conservative Treatment in Patients With Painful Osteoporotic Vertebral Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016103', 'term': 'Spinal Fractures'}, {'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D001416', 'term': 'Back Pain'}], 'ancestors': [{'id': 'D013124', 'term': 'Spinal Injuries'}, {'id': 'D019567', 'term': 'Back Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2011-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-22', 'studyFirstSubmitDate': '2009-10-13', 'studyFirstSubmitQcDate': '2009-10-13', 'lastUpdatePostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact into quality of life with the Qualeffo-41 test', 'timeFrame': 'Baseline, 2 weeks, 2 months, 6 months and 1 year'}], 'secondaryOutcomes': [{'measure': 'Analyze pain alleviation with the Analog Visual Scale', 'timeFrame': 'Baseline, 2 weeks, 2 months, 6 months and 1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['vertebroplasty', 'disability evaluation', 'outcome assessment', 'pain measurement'], 'conditions': ['Spinal Fracture', 'Osteoporosis', 'Back Pain']}, 'referencesModule': {'references': [{'pmid': '22513649', 'type': 'DERIVED', 'citation': 'Blasco J, Martinez-Ferrer A, Macho J, San Roman L, Pomes J, Carrasco J, Monegal A, Guanabens N, Peris P. Effect of vertebroplasty on pain relief, quality of life, and the incidence of new vertebral fractures: a 12-month randomized follow-up, controlled trial. J Bone Miner Res. 2012 May;27(5):1159-66. doi: 10.1002/jbmr.1564.'}], 'seeAlsoLinks': [{'url': 'http://www.iofbonehealth.org/', 'label': 'International Osteoporosis Foundation'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether percutaneous vertebroplasty is able to improve long-term quality of life in patients with pain secondary to osteoporotic vertebral fractures, compared to conventional medical treatment.', 'detailedDescription': 'Osteoporotic vertebral fractures are associated with pain and severe disability in a high percentage of patients. Vertebroplasty has become the treatment of choice to alleviate pain in those patients who have not responded to medical treatment.Although several case series and non-randomized studies have shown the effectiveness of vertebroplasty in alleviating pain secondary to osteoporotic vertebral fractures, the long-term effect of this treatment has not been compared to standard medical treatment in a randomized study.\n\nIn our study we have analyzed the long-term effect of vertebroplasty in terms of quality of life in patients with painful osteoporotic vertebral fractures, randomizing them into two arms: percutaneous vertebroplasty or conventional medical treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Painful (pain intensity of at least 4 on a scale from 0 to 10) osteoporotic vertebral fracture between levels T4 and L5\n* Fragility; i.e. fracture not in relation with significant trauma\n* Recent fracture, pain beginning not earlier than 1 year before inclusion\n\nExclusion Criteria:\n\n* No vertebral edema on STIR MR images\n* Uncorrectable bleeding diatheses\n* Active infection\n* Substantial retropulsion of bony fragments\n* Non-osteoporotic fracture\n* Concomitant neoplasm'}, 'identificationModule': {'nctId': 'NCT00994032', 'briefTitle': 'Quality of Life After Vertebroplasty Versus Conservative Treatment in Patients With Painful Osteoporotic Vertebral Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'officialTitle': 'Analysis of the Impact in the Quality of Life of Patients With Pain Secondary to Osteoporotic Vertebral Fractures Receiving Conservative Treatment Versus Percutaneous Vertebroplasty', 'orgStudyIdInfo': {'id': 'HCPB-VP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'vertebroplasty', 'interventionNames': ['Procedure: percutaneous injection of cement into the vertebral body']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Medical Treatment', 'interventionNames': ['Other: Medical treatment']}], 'interventions': [{'name': 'percutaneous injection of cement into the vertebral body', 'type': 'PROCEDURE', 'description': 'percutaneous injection of cement into the vertebral body', 'armGroupLabels': ['vertebroplasty']}, {'name': 'Medical treatment', 'type': 'OTHER', 'description': 'standard antalgic medical treatment', 'armGroupLabels': ['Medical Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Hospital Clinic of Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Jordi Blasco, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clinic of Barcelona'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sociedad Española de Radiologia Medica', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'JORDI BLASCO ANDALUZ', 'investigatorAffiliation': 'Hospital Clinic of Barcelona'}}}}