Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2026-02-25 @ 9:48 PM
Study NCT ID:
NCT01745068
Status:
UNKNOWN
Last Update Posted:
2018-10-29
First Post:
2012-12-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Partnership for Applied Research in Fracture Prevention Programs for the Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-10-17', 'releaseDate': '2019-09-23'}], 'estimatedResultsFirstSubmitDate': '2019-09-23'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 631}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-26', 'studyFirstSubmitDate': '2012-12-05', 'studyFirstSubmitQcDate': '2012-12-05', 'lastUpdatePostDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of secondary fragility fracture', 'timeFrame': '18 months post recruitment'}], 'secondaryOutcomes': [{'measure': 'Initiation of osteoporosis treatment by the primary care physician', 'timeFrame': 'At 6, 12, 18, and 60 months post recruitment', 'description': 'Osteoporosis treatment includes bisphosphonates or other effective osteoporosis drugs.'}, {'measure': 'Compliance with osteoporosis treatment.', 'timeFrame': 'At 6, 12, 18, and 60 months post recruitment', 'description': "The data collected from the participant will be validated with the participant's pharmacist through the medication possession ratio. The medication possession ratio is measured from the first to the last prescription, with the denominator being the duration from index to the exhaustion of the last prescription and the numerator being the days supplied over that period from first to last prescription and the numerator being the total number of days in the interval."}, {'measure': 'Time to first fall event', 'timeFrame': 'Within the first 18 months post recruitment'}, {'measure': 'Incidence of secondary fragility fractures.', 'timeFrame': 'At 24, 36, 48 and 60 months post recruitment'}, {'measure': 'Number of clinically significant fall events.', 'timeFrame': 'At 18, 24, 36, 48 and 60 months post recruitment'}, {'measure': 'Fall-related hospitalizations', 'timeFrame': 'At 18, 24, 36, 48 and 60 months post recruitment', 'description': "Fall-related hospitalizations will be recorded in the participant diary and at each telephone follow-up, and validated with the participant's hospital records."}, {'measure': 'Fragility fracture-related death', 'timeFrame': 'At 18, 24, 36, 48 and 60 months post recruitment', 'description': "Fragility fracture-related death will be confirmed from a provincial administrative database (Regie de l'assurance maladie du Quebec - RAMQ)."}, {'measure': "Participants' quality of life", 'timeFrame': 'At 18, 24, 36, 48 and 60 months post recruitment', 'description': 'Euro-QOL'}, {'measure': 'Practice of physical activities', 'timeFrame': 'At 6, 12, 18, 24, 36, 48 and 60 months post recruitment', 'description': 'CHAMPS'}, {'measure': 'Fragility fracture-related costs', 'timeFrame': 'At 18 and 60 months post recruitment', 'description': "Medical costs from the participant's hospital record include: medical assessment, prescription and non-prescription drugs; and resource use related to the management of the fragility fracture and/or long-term complications, including hospitalization. As well, lost days of work, annual income (if the participant is in the labour force), travel to the hospital and/or rehabilitation facilities, parking, and out-of-pocket expenses for drugs and rehabilitation devices (e.g. splint) will be compiled. Protocol-driven costs will be excluded, with the exception of the costs related to the participants' fall prevention program."}, {'measure': 'Admission to a long-term care facility', 'timeFrame': 'At 18, 24, 36, 48 and 60 months post recruitment'}, {'measure': "Participants' perceptions of care integration", 'timeFrame': 'At 12 months post intervention', 'description': "All participants' perceptions of care integration will be captured 12 months after the beginning of the intervention period, or following an early withdrawal from the study."}, {'measure': "Intervention participant's satisfaction with the fragility fracture prevention program", 'timeFrame': 'At 12 months post intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['fragility fracture', 'osteoporosis', 'fall prevention', 'integrated program', 'interorganizational collaboration', 'Canada', 'controlled clinical trial', 'evaluation'], 'conditions': ['Osteoporosis With Current Fragility Fracture']}, 'referencesModule': {'references': [{'pmid': '23343392', 'type': 'DERIVED', 'citation': 'Gaboury I, Corriveau H, Boire G, Cabana F, Beaulieu MC, Dagenais P, Gosselin S, Bogoch E, Rochette M, Filiatrault J, Laforest S, Jean S, Fansi A, Theriault D, Burnand B. Partnership for fragility bone fracture care provision and prevention program (P4Bones): study protocol for a secondary fracture prevention pragmatic controlled trial. Implement Sci. 2013 Jan 24;8:10. doi: 10.1186/1748-5908-8-10.'}]}, 'descriptionModule': {'briefSummary': "During their lifetime, approximately 50% of Canadian women and 30% of Canadian men will experience at least one fracture due to bone fragility (FF). Evidence is growing regarding prevention programs' effectiveness to prevent falls, but prevention of fractures through fall prevention programs has enjoyed limited success. Falls prevention programs and post-fracture screening programs leading to pharmacological treatment are very different strategies, with a shared ultimate goal. Coordination between those who repair fractures and those who manage the patient to prevent the next fracture is critical. The overarching aim of this proposal is to generate evidence-based knowledge about the effectiveness and cost-effectiveness of an integrated FF prevention program, as well as a portrait of the barriers and facilitating factors for such programs. More specifically, the objectives are: 1) to combine existing fall prevention and post-fracture management programs in the province of Quebec into integrated FF prevention programs; 2) to compare the performance of these integrated programs to control sites, using a pragmatic study design; 3) to identify barriers as well as factors that improve effectiveness across different implementation milieu; and 4) to develop and engage in active knowledge transfer activities in Quebec regions where integrated FF prevention programs are neither adequately nor successfully implemented. Drawing upon the literature on integrated healthcare, fall and fracture prevention, we hypothesize that an integrated FF program can reduce the risk of a subsequent fracture by at least 30% in the population of interest. The proposed team is poised to develop new interdisciplinary collaborations among healthcare practitioners and decision makers involved in the prevention of FFs. The program is built upon existing healthcare and structures and programs and in turn, will truly measure the effectiveness of an integrated FF prevention program. The results will ultimately lead to improvements in the existing knowledge base, address policy-relevant and health systems problems, and assist in the design and implementation of FFs prevention programs."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 50 years of age and over\n* must have a primary care physician\n* must be able to follow simple instructions\n* must have sustained a fragility fracture within three months of the recruitment date.\n\nExclusion Criteria:\n\n* severe kidney insufficiency (grade 4 or 5)\n* advanced stage of cancer\n* fracture to sites not commonly associated with osteoporosis such as toe, finger, hand, foot, ankle, patella, head, and cervical spine.'}, 'identificationModule': {'nctId': 'NCT01745068', 'acronym': 'OPTI-FRAC', 'briefTitle': 'Partnership for Applied Research in Fracture Prevention Programs for the Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Université de Sherbrooke'}, 'officialTitle': 'Partnership for Applied Research in Fracture Prevention Programs for the Elderly', 'orgStudyIdInfo': {'id': 'CIHR grant # 267395'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group'}, {'type': 'EXPERIMENTAL', 'label': 'Integrated program', 'description': 'Participants will be involved in an integrated interorganisational fragility fracture prevention program, which combines both post-fracture management as well as fall prevention strategies. The intervention will last up to 18 months.', 'interventionNames': ['Other: Integrated program']}], 'interventions': [{'name': 'Integrated program', 'type': 'OTHER', 'description': "Each participant's primary care physician will receive written information containing a presumed osteoporosis diagnosis, investigations to be performed, correct interpretation of any bone densitometry results in the context of a fragility fracture, and treatment options. The study coordinator will be responsible for orienting the participant to an appropriate local fall prevention program.", 'armGroupLabels': ['Integrated program']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'J9T 2S2', 'city': 'Amos', 'state': 'Quebec', 'country': 'Canada', 'facility': "Centre hospitalier Hôtel-Dieu d'Amos", 'geoPoint': {'lat': 48.56688, 'lon': -78.11624}}, {'zip': 'G0C 1K0', 'city': 'Chandler', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CSSS du Roché Percé (Centre hospitalier de Chandler)', 'geoPoint': {'lat': 48.34935, 'lon': -64.67926}}, {'zip': 'J8Y 1W7', 'city': 'Gatineau', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hôpital de Hull', 'geoPoint': {'lat': 45.47723, 'lon': -75.70164}}, {'zip': 'J4V 2H1', 'city': 'Greenfield Park', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hôpital Charles Lemoyne', 'geoPoint': {'lat': 45.48649, 'lon': -73.46223}}, {'zip': 'H1T 2M4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hôpital Maisonneuve-Rosemont', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2E1S6', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hôpital Jean-Talon', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H4J 1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hôpital Sacré-Coeur de Montréal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'J6E 6J2', 'city': 'Saint-Charles-Borromée', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre hospitalier régional de Lanaudière', 'geoPoint': {'lat': 46.05007, 'lon': -73.46586}}, {'zip': 'J7Z 5T3', 'city': 'Saint-Jérôme', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CSSS de St-Jérôme (Hôpital régional de St-Jérôme)', 'geoPoint': {'lat': 45.78036, 'lon': -74.00365}}, {'zip': 'J1H5N4', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre Hospitalier Universitaire de Sherbrooke', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}], 'overallOfficials': [{'name': 'Isabelle Gaboury, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Sherbrooke'}, {'name': 'Hélène Corriveau, PhD pht', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Sherbrooke'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Sherbrooke', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}, {'name': 'Ministere de la Sante et des Services Sociaux', 'class': 'OTHER'}, {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, {'name': 'Novartis', 'class': 'INDUSTRY'}, {'name': 'Amgen', 'class': 'INDUSTRY'}, {'name': 'CSSS-IUGS Estrie', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Isabelle Gaboury', 'investigatorAffiliation': 'Université de Sherbrooke'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-09-23', 'type': 'RELEASE'}, {'date': '2019-10-17', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Isabelle Gaboury, Associate Professor, Université de Sherbrooke'}}}}