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

Osteoporosis Clinical Trial

Official title:

Falls, Fracture, and Osteoporosis Risk Control Evaluation (FORCE) Study: A Randomized Controlled Trial With Community Partnerships in Northern Ontario

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00465387
• Other study ID #: FORCE1234
• Status: Completed
• Phase: N/A
• First received: April 24, 2007
• Last updated: April 24, 2007
• Start date: March 2003
• Est. completion date: January 2006

Study information

• Verified date: April 2007
• Source: Group Health Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Behavioral:
• Falls, Fractures & Osteoporosis Risk Assessment & Management

Locations

Country	Name	City	State
n/a

Sponsors (7)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.

External Links

•   Group Health Centre website