Partnership for Applied Research in Fracture Prevention Programs for the Elderly

NCT ID: NCT01745068

Last Updated: 2018-10-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 631 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2019-06-30

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.

Conditions

Osteoporosis With Current Fragility Fracture

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Integrated program

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility 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 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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Ministere de la Sante et des Services Sociaux

OTHER

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Novartis

INDUSTRY

Sponsor Role: collaborator

Amgen

INDUSTRY

Sponsor Role: collaborator

CSSS-IUGS Estrie

UNKNOWN

Sponsor Role: collaborator

Université de Sherbrooke

OTHER

Sponsor Role: lead

Responsible Party

Isabelle Gaboury

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Isabelle Gaboury, PhD

Role: PRINCIPAL_INVESTIGATOR

Université de Sherbrooke

Hélène Corriveau, PhD pht

Role: PRINCIPAL_INVESTIGATOR

Université de Sherbrooke

Locations

Centre hospitalier Hôtel-Dieu d'Amos

Amos, Quebec, Canada

CSSS du Roché Percé (Centre hospitalier de Chandler)

Chandler, Quebec, Canada

Hôpital de Hull

Gatineau, Quebec, Canada

Hôpital Charles Lemoyne

Greenfield Park, Quebec, Canada

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Hôpital Jean-Talon

Montreal, Quebec, Canada

Hôpital Sacré-Coeur de Montréal

Montreal, Quebec, Canada

Centre hospitalier régional de Lanaudière

Saint-Charles-Borromée, Quebec, Canada

CSSS de St-Jérôme (Hôpital régional de St-Jérôme)

Saint-Jérôme, Quebec, Canada

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Countries

Canada

References

Gaboury I, Corriveau H, Boire G, Cabana F, Beaulieu MC, Dagenais P, Gosselin S, Bogoch E, Rochette M, Filiatrault J, Laforest S, Jean S, Fansi A, Theriault D, Burnand B. Partnership for fragility bone fracture care provision and prevention program (P4Bones): study protocol for a secondary fracture prevention pragmatic controlled trial. Implement Sci. 2013 Jan 24;8:10. doi: 10.1186/1748-5908-8-10.

Reference Type: DERIVED

PMID: 23343392 (View on PubMed)

Other Identifiers

CIHR grant # 267395

Identifier Type: -

Identifier Source: org_study_id