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

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ClinicalTrials.gov Identifier: NCT00465387
Recruitment Status : Completed
First Posted : April 25, 2007
Last Update Posted : April 25, 2007
Sponsor:
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
Information provided by:
Group Health Centre

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.

Condition or disease Intervention/treatment Phase
Osteoporosis Behavioral: Falls, Fractures & Osteoporosis Risk Assessment & Management Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Falls, Fracture, and Osteoporosis Risk Control Evaluation (FORCE) Study: A Randomized Controlled Trial With Community Partnerships in Northern Ontario
Study Start Date : March 2003
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. 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.


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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 ClinicalTrials.gov identifier (NCT number): NCT00465387


Sponsors and Collaborators
Group Health Centre
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
Investigators
Principal Investigator: Patricia M. Ciaschini, MD, FRCPC Group Health Centre, Sault Ste. Marie, ON, Canada
Principal Investigator: Sharon E. Straus, MD MSc FRCPC University of Toronto, ON, Canada