Osteoporosis With Current Fragility FractureOPTI-FRACNCT01745068
Partnership for Applied Research in Fracture Prevention Programs for the Elderly
A study testing Integrated program in people with Osteoporosis With Current Fragility Fracture, run by Université de Sherbrooke at 10 sites in Canada.
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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoporosis With Current Fragility Fracture
- What is being tested?
- Integrated program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 631 participants
- Where
- 10 sitesCanada
- Study dates
- Jan 2013to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Canada10 sites
Centre hospitalier Hôtel-Dieu d'Amos
Amos, Quebec, J9T 2S2
CSSS du Roché Percé (Centre hospitalier de Chandler)
Chandler, Quebec, G0C 1K0
Hôpital de Hull
Gatineau, Quebec, J8Y 1W7
Hôpital Charles Lemoyne
Greenfield Park, Quebec, J4V 2H1
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
Hôpital Jean-Talon
Montreal, Quebec, H2E1S6
Hôpital Sacré-Coeur de Montréal
Montreal, Quebec, H4J 1C5
Centre hospitalier régional de Lanaudière
Saint-Charles-Borromée, Quebec, J6E 6J2
CSSS de St-Jérôme (Hôpital régional de St-Jérôme)
Saint-Jérôme, Quebec, J7Z 5T3
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H5N4
About this study
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.
- Being tested
- Integrated program
- Keywords
- fragility fracture, osteoporosis, fall prevention, integrated program, interorganizational collaboration, Canada, controlled clinical trial, evaluation
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Not described |
| 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. Receives: Other: Integrated program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of secondary fragility fracture
Measured: 18 months post recruitment
Secondary outcomes (13)
Initiation of osteoporosis treatment by the primary care physician
Osteoporosis treatment includes bisphosphonates or other effective osteoporosis drugs.
Measured: At 6, 12, 18, and 60 months post recruitment
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.
Measured: At 6, 12, 18, and 60 months post recruitment
Time to first fall event
Measured: Within the first 18 months post recruitment
Incidence of secondary fragility fractures.
Measured: At 24, 36, 48 and 60 months post recruitment
Number of clinically significant fall events.
Measured: At 18, 24, 36, 48 and 60 months post recruitment
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.
Measured: At 18, 24, 36, 48 and 60 months post recruitment
Fragility fracture-related death
Fragility fracture-related death will be confirmed from a provincial administrative database (Regie de l'assurance maladie du Quebec - RAMQ).
Measured: At 18, 24, 36, 48 and 60 months post recruitment
Participants' quality of life
Euro-QOL
Measured: At 18, 24, 36, 48 and 60 months post recruitment
Practice of physical activities
CHAMPS
Measured: At 6, 12, 18, 24, 36, 48 and 60 months post recruitment
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.
Measured: At 18 and 60 months post recruitment
Admission to a long-term care facility
Measured: At 18, 24, 36, 48 and 60 months post recruitment
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.
Measured: At 12 months post intervention
Intervention participant's satisfaction with the fragility fracture prevention program
Measured: At 12 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionNov 2016
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoporosis With Current Fragility FractureStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 631 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Ministere de la Sante et des Services Sociaux, Merck Sharp & Dohme LLC, Novartis, Amgen, CSSS-IUGS Estrie
- Responsible party
- Principal investigator, Isabelle Gaboury, Université de Sherbrooke
- Investigators
- Isabelle Gaboury, PhD, Principal investigator, Université de SherbrookeHélène Corriveau, PhD pht, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01745068
- Sponsor's protocol ID
- CIHR grant # 267395
- Acronym
- OPTI-FRAC
- Status last verified
- Oct 2018
- First submitted
- 5 Dec 2012
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23343392
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partnership for Applied Research in Fracture Prevention Programs for the Elderly
- ClinicalTrials.gov ID
- NCT01745068
- Acronym / sponsor ID
- OPTI-FRAC / CIHR grant # 267395
- Keywords
- fragility fracture, osteoporosis, fall prevention, integrated program, interorganizational collaboration, Canada, controlled clinical trial, evaluation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 631 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Ministere de la Sante et des Services Sociaux, Merck Sharp & Dohme LLC, Novartis, Amgen, CSSS-IUGS Estrie
- Study start
- Jan 2013
- Primary completion
- Nov 2016 (actual)
- Study completion
- Jun 2019 (estimated)
- First posted
- 7 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | – |
| Integrated program | Experimental | Other: Integrated programParticipants 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated programEach 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. | Other | Integrated program |
Primary outcome
Incidence of secondary fragility fracture
Time frame: 18 months post recruitment
13 secondary outcomes
Initiation of osteoporosis treatment by the primary care physician
Time frame: At 6, 12, 18, and 60 months post recruitment
Compliance with osteoporosis treatment.
Time frame: At 6, 12, 18, and 60 months post recruitment
Time to first fall event
Time frame: Within the first 18 months post recruitment
Incidence of secondary fragility fractures.
Time frame: At 24, 36, 48 and 60 months post recruitment
Number of clinically significant fall events.
Time frame: At 18, 24, 36, 48 and 60 months post recruitment
Fall-related hospitalizations
Time frame: At 18, 24, 36, 48 and 60 months post recruitment
Fragility fracture-related death
Time frame: At 18, 24, 36, 48 and 60 months post recruitment
Participants' quality of life
Time frame: At 18, 24, 36, 48 and 60 months post recruitment
Practice of physical activities
Time frame: At 6, 12, 18, 24, 36, 48 and 60 months post recruitment
Fragility fracture-related costs
Time frame: At 18 and 60 months post recruitment
Admission to a long-term care facility
Time frame: At 18, 24, 36, 48 and 60 months post recruitment
Participants' perceptions of care integration
Time frame: At 12 months post intervention
Intervention participant's satisfaction with the fragility fracture prevention program
Time frame: At 12 months post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- Derived from this study: PubMed 23343392Gaboury 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Gaboury, PhD principal investigator
Université de Sherbrooke
Hélène Corriveau, PhD pht principal investigator
Université de Sherbrooke
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated program in people with Osteoporosis With Current Fragility Fracture, run by Université de Sherbrooke at 10 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of secondary fragility fracture (time frame: 18 months post recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01745068, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2018; AzTrials last refreshed its copy on 2 Nov 2026.