Partnership for Applied Research in Fracture Prevention Programs for the Elderly

Osteoporosis With Current Fragility Fracture Clinical Trial

— OPTI-FRAC  

Official title:

Partnership for Applied Research in Fracture Prevention Programs for the Elderly

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01745068
• Other study ID #: CIHR grant # 267395
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2013
• Est. completion date: June 2019

Study information

• Verified date: October 2018
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 631
• Est. completion date: June 2019
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Osteoporosis
• Osteoporosis With Current Fragility Fracture

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	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 Jean-Talon	Montreal	Quebec
Canada	Hôpital Maisonneuve-Rosemont	Montreal	Quebec
Canada	Hôpital Sacré-Coeur de Montréal	Montreal	Quebec
Canada	Centre hospitalier régional de Lanaudière	Saint-Charles-Borromée	Quebec
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec
Canada	CSSS de St-Jérôme (Hôpital régional de St-Jérôme)	St-Jérôme	Quebec

Sponsors (7)

Lead Sponsor	Collaborator
Université de Sherbrooke	Amgen, Canadian Institutes of Health Research (CIHR), CSSS-IUGS Estrie, Merck Sharp & Dohme Corp., Ministere de la Sante et des Services Sociaux, Novartis

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of secondary fragility fracture		18 months post recruitment
Secondary	Initiation of osteoporosis treatment by the primary care physician	Osteoporosis treatment includes bisphosphonates or other effective osteoporosis drugs.	At 6, 12, 18, and 60 months post recruitment
Secondary	Compliance with osteoporosis treatment.	The data collected from the participant will be validated with the participant's pharmacist through the medication possession ratio. The medication possession ratio is measured from the first to the last prescription, with the denominator being the duration from index to the exhaustion of the last prescription and the numerator being the days supplied over that period from first to last prescription and the numerator being the total number of days in the interval.	At 6, 12, 18, and 60 months post recruitment
Secondary	Time to first fall event		Within the first 18 months post recruitment
Secondary	Incidence of secondary fragility fractures.		At 24, 36, 48 and 60 months post recruitment
Secondary	Number of clinically significant fall events.		At 18, 24, 36, 48 and 60 months post recruitment
Secondary	Fall-related hospitalizations	Fall-related hospitalizations will be recorded in the participant diary and at each telephone follow-up, and validated with the participant's hospital records.	At 18, 24, 36, 48 and 60 months post recruitment
Secondary	Fragility fracture-related death	Fragility fracture-related death will be confirmed from a provincial administrative database (Regie de l'assurance maladie du Quebec - RAMQ).	At 18, 24, 36, 48 and 60 months post recruitment
Secondary	Participants' quality of life	Euro-QOL	At 18, 24, 36, 48 and 60 months post recruitment
Secondary	Practice of physical activities	CHAMPS	At 6, 12, 18, 24, 36, 48 and 60 months post recruitment
Secondary	Fragility fracture-related costs	Medical costs from the participant's hospital record include: medical assessment, prescription and non-prescription drugs; and resource use related to the management of the fragility fracture and/or long-term complications, including hospitalization. As well, lost days of work, annual income (if the participant is in the labour force), travel to the hospital and/or rehabilitation facilities, parking, and out-of-pocket expenses for drugs and rehabilitation devices (e.g. splint) will be compiled. Protocol-driven costs will be excluded, with the exception of the costs related to the participants' fall prevention program.	At 18 and 60 months post recruitment
Secondary	Admission to a long-term care facility		At 18, 24, 36, 48 and 60 months post recruitment
Secondary	Participants' perceptions of care integration	All participants' perceptions of care integration will be captured 12 months after the beginning of the intervention period, or following an early withdrawal from the study.	At 12 months post intervention
Secondary	Intervention participant's satisfaction with the fragility fracture prevention program		At 12 months post intervention