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Partnership for Applied Research in Fracture Prevention Programs for the Elderly (OPTI-FRAC)

This study is not yet open for participant recruitment.
Verified January 2013 by Universitaire de Sherbrooke
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Ministry of Health, Quebec
Merck
Novartis
Amgen
CSSS-IUGS Estrie
Information provided by (Responsible Party):
Isabelle Gaboury, Universitaire de Sherbrooke
ClinicalTrials.gov Identifier:
NCT01745068
First received: December 5, 2012
Last updated: January 16, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Osteoporosis With Current Fragility Fracture
 Other: Integrated program

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Partnership for Applied Research in Fracture Prevention Programs for the Elderly

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universitaire de Sherbrooke:

Primary Outcome Measures:
  • Incidence of secondary fragility fracture [ Time Frame: 18 months post recruitment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Initiation of osteoporosis treatment by the primary care physician [ Time Frame: At 6, 12, 18, and 60 months post recruitment ] [ Designated as safety issue: No ]
    Osteoporosis treatment includes bisphosphonates or other effective osteoporosis drugs.

  • Compliance with osteoporosis treatment. [ Time Frame: At 6, 12, 18, and 60 months post recruitment ] [ Designated as safety issue: No ]
    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.

  • Time to first fall event [ Time Frame: Within the first 18 months post recruitment ] [ Designated as safety issue: No ]
  • Incidence of secondary fragility fractures. [ Time Frame: At 24, 36, 48 and 60 months post recruitment ] [ Designated as safety issue: No ]
  • Number of clinically significant fall events. [ Time Frame: At 18, 24, 36, 48 and 60 months post recruitment ] [ Designated as safety issue: No ]
  • Fall-related hospitalizations [ Time Frame: At 18, 24, 36, 48 and 60 months post recruitment ] [ Designated as safety issue: No ]
    Fall-related hospitalizations will be recorded in the participant diary and at each telephone follow-up, and validated with the participant's hospital records.

  • Fragility fracture-related death [ Time Frame: At 18, 24, 36, 48 and 60 months post recruitment ] [ Designated as safety issue: No ]
    Fragility fracture-related death will be confirmed from a provincial administrative database (Regie de l'assurance maladie du Quebec - RAMQ).

  • Participants' quality of life [ Time Frame: At 18, 24, 36, 48 and 60 months post recruitment ] [ Designated as safety issue: No ]
    Euro-QOL

  • Practice of physical activities [ Time Frame: At 6, 12, 18, 24, 36, 48 and 60 months post recruitment ] [ Designated as safety issue: No ]
    CHAMPS

  • Fragility fracture-related costs [ Time Frame: At 18 and 60 months post recruitment ] [ Designated as safety issue: No ]
    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.

  • Admission to a long-term care facility [ Time Frame: At 18, 24, 36, 48 and 60 months post recruitment ] [ Designated as safety issue: No ]
  • Participants' perceptions of care integration [ Time Frame: At 12 months post intervention ] [ Designated as safety issue: No ]
    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.

  • Intervention participant's satisfaction with the fragility fracture prevention program [ Time Frame: At 12 months post intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 3192
Study Start Date: January 2013
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group
Experimental: Integrated program
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.
 Other: Integrated program
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 50 years of age and over
  • must have a primary care physician
  • must be able to follow simple instructions
  • must have sustained a fragility fracture within two months of the recruitment date.

Exclusion Criteria:

  • severe kidney insufficiency (grade 4 or 5)
  • advanced stage of cancer
  • fracture to sites not commonly associated with osteoporosis such as toe, finger, hand, foot, ankle, patella, head, and cervical spine.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01745068

Contacts
Contact: Valérie Trembaly-Boudreault, MSc 8198206868 ext 45684 valerie.tremblay-boudreault@usherbrooke.ca

Locations
Canada, Quebec
Centre hospitalier Hôtel-Dieu d'Amos Not yet recruiting
Amos, Quebec, Canada, J9T 2S2
Principal Investigator: To be determined            
Hôpital de Hull Not yet recruiting
Gatineau, Quebec, Canada, J8Y 1W7
Principal Investigator: To be determined            
Hôpital Charles Lemoyne Not yet recruiting
Greenfield Park, Quebec, Canada, J4V 2H1
Principal Investigator: Nathaly Gaudreault, PhD            
Hôpital Santa Cabrini Not yet recruiting
Montreal, Quebec, Canada, H1T 1P7
Principal Investigator: Pascal-André Vendittoli, MD, MSc            
Hôpital Sacré-Coeur de Montréal Not yet recruiting
Montreal, Quebec, Canada, H4J 1C5
Principal Investigator: Julio C Fernandes, MD            
Hôpital Jean-Talon Not yet recruiting
Montreal, Quebec, Canada, H2E1S6
Principal Investigator: Julio C Fernandes, MD            
Hôpital Maisonneuve-Rosemont Not yet recruiting
Montreal, Quebec, Canada, H1T 2M4
Principal Investigator: Pascal André Vendittoli, MD, MSc            
Centre hospitalier régional de Lanaudière Not yet recruiting
Saint-Charles-Borromée, Quebec, Canada, J6E 6J2
Principal Investigator: To be determined            
Hôpital et Centre d'hébergement de Sept-îles Not yet recruiting
Sept-Îles, Quebec, Canada, G4R 3N7
Principal Investigator: To be determined            
Centre Hospitalier Universitaire de Sherbrooke Not yet recruiting
Sherbrooke, Quebec, Canada, J1H5N4
Principal Investigator: Gilles Boire, MD            
Sub-Investigator: Francois Cabana, MD            
Centre hospitalier régional de Trois-Rivières-Sainte Marie Not yet recruiting
Trois-Rivières, Quebec, Canada, G8Z 3R9
Principal Investigator: To be determined            
Sponsors and Collaborators
Universitaire de Sherbrooke
Canadian Institutes of Health Research (CIHR)
Ministry of Health, Quebec
Merck
Novartis
Amgen
CSSS-IUGS Estrie
Investigators
Principal Investigator: Isabelle Gaboury, PhD Universitaire de Sherbrooke
Principal Investigator: Hélène Corriveau, PhD pht Universitaire de Sherbrooke
  More Information

No publications provided by Universitaire de Sherbrooke

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Isabelle Gaboury, Assistant professor, Universitaire de Sherbrooke
ClinicalTrials.gov Identifier: NCT01745068     History of Changes
Other Study ID Numbers: CIHR grant # 267395
Study First Received: December 5, 2012
Last Updated: January 16, 2013
Health Authority: Canada: Health Canada

Keywords provided by Universitaire de Sherbrooke:
fragility fracture
osteoporosis
fall prevention
integrated program
 interorganizational collaboration
Canada
controlled clinical trial
evaluation

Additional relevant MeSH terms:
Fractures, Bone
Osteoporosis
Wounds and Injuries
 Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 19, 2013