Partnership for Applied Research in Fracture Prevention Programs for the Elderly

NCT01745068 | Unknown

• 1 other identifier: CIHR grant # 267395
• Study Type: interventional
• Target: 631
• Locations: 1 country
• Sites: 10

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

Keywords

fragility fracture; osteoporosis; fall prevention; integrated program; interorganizational collaboration; Canada; controlled clinical trial; evaluation

Outcome Measures

Primary Outcomes (1)

• Incidence of secondary fragility fracture

  18 months post recruitment

Secondary Outcomes (13)

• Initiation of osteoporosis treatment by the primary care physician

  At 6, 12, 18, and 60 months post recruitment

• Compliance with osteoporosis treatment.

  At 6, 12, 18, and 60 months post recruitment

• Time to first fall event

  Within the first 18 months post recruitment

• Incidence of secondary fragility fractures.

  At 24, 36, 48 and 60 months post recruitment

• Number of clinically significant fall events.

  At 18, 24, 36, 48 and 60 months post recruitment

Study Arms (2)

Control group

NO INTERVENTION

Integrated program

EXPERIMENTAL

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

Interventions

Integrated program 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.

Integrated program

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Ministere de la Sante et des Services Sociaux: collaborator
• Merck Sharp & Dohme LLC: collaborator
• Novartis: collaborator
• Amgen: collaborator
• CSSS-IUGS Estrie: collaborator

Study Sites (10)

Centre hospitalier Hôtel-Dieu d'Amos

Amos, Quebec, J9T 2S2, Canada

Location

CSSS du Roché Percé (Centre hospitalier de Chandler)

Chandler, Quebec, G0C 1K0, Canada

Location

Hôpital de Hull

Gatineau, Quebec, J8Y 1W7, Canada

Location

Hôpital Charles Lemoyne

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

Hôpital Jean-Talon

Montreal, Quebec, H2E1S6, Canada

Location

Hôpital Sacré-Coeur de Montréal

Montreal, Quebec, H4J 1C5, Canada

Location

Centre hospitalier régional de Lanaudière

Saint-Charles-Borromée, Quebec, J6E 6J2, Canada

Location

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

Saint-Jérôme, Quebec, J7Z 5T3, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H5N4, Canada

Location

Related Publications (1)

• 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.

  PMID: 23343392 DERIVED

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Isabelle Gaboury, PhD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

• Hélène Corriveau, PhD pht

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: December 5, 2012
• First Posted: December 7, 2012
• Study Start: January 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: June 1, 2019
• Last Updated: October 29, 2018

Record last verified: 2018-10

Locations

CA (10)