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FORCE (Falls, Fracture, and Osteoporosis Risk Control Evaluation) Study

Primary Purpose

Osteoporosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Falls, Fractures & Osteoporosis Risk Assessment & Management
Sponsored by
Group Health Centre
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 55 years of age or older
  • independent living within the city of Sault Ste. Marie, Ontario, Canada
  • capable of providing informed consent

Exclusion Criteria:

  • not at risk for falls
  • unable to give informed consent

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Fall risk management, assessment and management of gate, strength and balance deficits, completion of medication review, including postural hypotension and psychotropic medications as well as the assessment and management of environmental risk factors.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 24, 2007
    Last Updated
    April 24, 2007
    Sponsor
    Group Health Centre
    Collaborators
    Sault Area Hospital, Algoma Community Care Access Centre, Pharma Companies Alliance (Aventis and Proctor & Gamble), Merck Frosst Canada Ltd., Eli Lilly and Company, The Green Shield Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00465387
    Brief Title
    FORCE (Falls, Fracture, and Osteoporosis Risk Control Evaluation) Study
    Official Title
    Falls, Fracture, and Osteoporosis Risk Control Evaluation (FORCE) Study: A Randomized Controlled Trial With Community Partnerships in Northern Ontario
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    January 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Group Health Centre
    Collaborators
    Sault Area Hospital, Algoma Community Care Access Centre, Pharma Companies Alliance (Aventis and Proctor & Gamble), Merck Frosst Canada Ltd., Eli Lilly and Company, The Green Shield Foundation

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Falls and osteoporosis-related fractures cause substantial morbidity and mortality in the elderly, and are an increasingly important public health concern. A comprehensive multidisciplinary and integrated community-based approach is needed to identify and manage the population at highest risk of these complications. Unfortunately, current gaps in continuity of care and health intervention result in a sub-optimal state of health service for these individuals. The Falls, Fracture and Osteoporosis Risk Control and Evaluation (FORCE) Study is a two-year randomized controlled trial evaluated on the effect of coordinated community-based, multidisciplinary approach for fall and fracture prevention in Sault Ste. Marie.
    Detailed Description
    The FORCE partners are a broad collaboration of interested consumers, stakeholders and providers, led by the Algoma Health Unit (AHU) and the Group Health Centre (GHC) - a community-based, not-for-profit, multidisciplinary health organization. Other partners include the multi-agency, consumer-orientated Algoma District Slips, Trips and Falls Committee, the Sault Area Hospital (SAH), the Algoma Community Care Access Centre (ACCAC), and Pharma Companies Alliance (Aventis and Proctor & Gamble), Merck Frosst and Lilly. The Green Shield Foundation has also provided sponsorship.The results of this study might directly benefit up to eight thousand seniors in the district by providing the impetus to integrated, evidence-based health services. Qualitative and quantitative research during this time will also be a unique opportunity to identify the modifiable barriers to the continuity and quality of care in this high-risk population. By involving the community, the project will also educate those at future risk and hopefully prevent disease and complications. Evaluation and research should provide nationally suggestions for better health service delivery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoporosis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    400 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    Falls, Fractures & Osteoporosis Risk Assessment & Management
    Primary Outcome Measure Information:
    Title
    Fall risk management, assessment and management of gate, strength and balance deficits, completion of medication review, including postural hypotension and psychotropic medications as well as the assessment and management of environmental risk factors.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 55 years of age or older independent living within the city of Sault Ste. Marie, Ontario, Canada capable of providing informed consent Exclusion Criteria: not at risk for falls unable to give informed consent
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Patricia M. Ciaschini, MD, FRCPC
    Organizational Affiliation
    Group Health Centre, Sault Ste. Marie, ON, Canada
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Sharon E. Straus, MD MSc FRCPC
    Organizational Affiliation
    University of Toronto, ON, Canada
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20799973
    Citation
    Ciaschini PM, Straus SE, Dolovich LR, Goeree RA, Leung KM, Woods CR, Zimmerman GM, Majumdar SR, Spadafora S, Fera LA, Lee HN. Community based intervention to optimize osteoporosis management: randomized controlled trial. BMC Geriatr. 2010 Aug 27;10:60. doi: 10.1186/1471-2318-10-60.
    Results Reference
    derived
    PubMed Identifier
    18983670
    Citation
    Ciaschini PM, Straus SE, Dolovich LR, Goeree RA, Leung KM, Woods CR, Zimmerman GM, Majumdar SR, Spadafora S, Fera LA, Lee HN. Community-based randomised controlled trial evaluating falls and osteoporosis risk management strategies. Trials. 2008 Nov 4;9:62. doi: 10.1186/1745-6215-9-62.
    Results Reference
    derived
    Links:
    URL
    http://www.ghc.on.ca
    Description
    Group Health Centre website

    Learn more about this trial

    FORCE (Falls, Fracture, and Osteoporosis Risk Control Evaluation) Study

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