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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01745068
Recruitment Status : Unknown
Verified October 2018 by Isabelle Gaboury, Université de Sherbrooke.
Recruitment status was:  Active, not recruiting
First Posted : December 7, 2012
Last Update Posted : October 29, 2018
Canadian Institutes of Health Research (CIHR)
Ministere de la Sante et des Services Sociaux
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Isabelle Gaboury, Université de Sherbrooke

Brief Summary:
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 or disease Intervention/treatment Phase
Osteoporosis With Current Fragility Fracture Other: Integrated program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 631 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Partnership for Applied Research in Fracture Prevention Programs for the Elderly
Study Start Date : January 2013
Actual Primary Completion Date : November 2016
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Incidence of secondary fragility fracture [ Time Frame: 18 months post recruitment ]

Secondary Outcome Measures :
  1. Initiation of osteoporosis treatment by the primary care physician [ Time Frame: At 6, 12, 18, and 60 months post recruitment ]
    Osteoporosis treatment includes bisphosphonates or other effective osteoporosis drugs.

  2. Compliance with osteoporosis treatment. [ Time Frame: At 6, 12, 18, and 60 months post recruitment ]
    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.

  3. Time to first fall event [ Time Frame: Within the first 18 months post recruitment ]
  4. Incidence of secondary fragility fractures. [ Time Frame: At 24, 36, 48 and 60 months post recruitment ]
  5. Number of clinically significant fall events. [ Time Frame: At 18, 24, 36, 48 and 60 months post recruitment ]
  6. Fall-related hospitalizations [ Time Frame: At 18, 24, 36, 48 and 60 months post recruitment ]
    Fall-related hospitalizations will be recorded in the participant diary and at each telephone follow-up, and validated with the participant's hospital records.

  7. Fragility fracture-related death [ Time Frame: At 18, 24, 36, 48 and 60 months post recruitment ]
    Fragility fracture-related death will be confirmed from a provincial administrative database (Regie de l'assurance maladie du Quebec - RAMQ).

  8. Participants' quality of life [ Time Frame: At 18, 24, 36, 48 and 60 months post recruitment ]

  9. Practice of physical activities [ Time Frame: At 6, 12, 18, 24, 36, 48 and 60 months post recruitment ]

  10. Fragility fracture-related costs [ Time Frame: At 18 and 60 months post recruitment ]
    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.

  11. Admission to a long-term care facility [ Time Frame: At 18, 24, 36, 48 and 60 months post recruitment ]
  12. Participants' perceptions of care integration [ Time Frame: At 12 months post intervention ]
    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.

  13. Intervention participant's satisfaction with the fragility fracture prevention program [ Time Frame: At 12 months post intervention ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 three 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01745068

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Canada, Quebec
Centre hospitalier Hôtel-Dieu d'Amos
Amos, Quebec, Canada, J9T 2S2
CSSS du Roché Percé (Centre hospitalier de Chandler)
Chandler, Quebec, Canada, G0C 1K0
Hôpital de Hull
Gatineau, Quebec, Canada, J8Y 1W7
Hôpital Charles Lemoyne
Greenfield Park, Quebec, Canada, J4V 2H1
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada, H1T 2M4
Hôpital Jean-Talon
Montreal, Quebec, Canada, H2E1S6
Hôpital Sacré-Coeur de Montréal
Montreal, Quebec, Canada, H4J 1C5
Centre hospitalier régional de Lanaudière
Saint-Charles-Borromée, Quebec, Canada, J6E 6J2
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H5N4
CSSS de St-Jérôme (Hôpital régional de St-Jérôme)
St-Jérôme, Quebec, Canada, J7Z 5T3
Sponsors and Collaborators
Université de Sherbrooke
Canadian Institutes of Health Research (CIHR)
Ministere de la Sante et des Services Sociaux
Merck Sharp & Dohme Corp.
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Principal Investigator: Isabelle Gaboury, PhD Université de Sherbrooke
Principal Investigator: Hélène Corriveau, PhD pht Université de Sherbrooke
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Isabelle Gaboury, Assistant professor, Université de Sherbrooke Identifier: NCT01745068    
Other Study ID Numbers: CIHR grant # 267395
First Posted: December 7, 2012    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018
Keywords provided by Isabelle Gaboury, Université de Sherbrooke:
fragility fracture
fall prevention
integrated program
interorganizational collaboration
controlled clinical trial
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases