Recognizing Osteoporosis and Its Consequences in Quebec (ROCQ) Programme
1 other identifier
interventional
2,830
1 country
1
Brief Summary
The aim of the ROCQ programme is to improve the use of evidence based osteoporosis diagnostic and treatment strategies for women 50 years and over who have suffered a fragility fracture. This objective will be achieved by concentrating on a realistic evaluation of the present diagnosis and treatment rate of osteoporosis following a fragility fracture and comparing it to an optimal situation (care gap) and proposing interventions that promote new approaches to treating osteoporosis by health professionals as well as providing targeted interventions for the patient. The efficacy of these interventions will be evaluated using a randomized control design.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2003
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
July 28, 2006
CompletedFirst Posted
Study publicly available on registry
August 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedNovember 21, 2017
November 1, 2017
4.3 years
July 28, 2006
November 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
The present diagnostic and treatment rates of osteoporosis 6 months after a fragility fracture
June 2007
The osteoporosis diagnostic rate and on the osteoporosis pharmacological treatment rate 12 months after the educational interventions
June 2007
The average 5-year, 10-year, 15-year, and 20-year probabilities of a fragility fracture by age, site of previous fragility fracture, and type of ROCQ intervention.
July 2009
Secondary Outcomes (8)
Changes of modifiable risk factors for osteoporosis 12 months after the intervention
September 2009
Proportion of fragility versus traumatic fractures.
June 2007
Health care resource utilization associated with specific types of fragility fracture and recurrent fractures.
September 2010
Assess health utility index (EQ-5D) after a fragility fracture.
September 2010
Satisfaction with the process of care before and after implementing ROCQ's interventions.
June 2010
- +3 more secondary outcomes
Study Arms (2)
Documentation
EXPERIMENTALWritten educational material on osteoporosis for the participant and the physician.
Video
EXPERIMENTALA 15-minute educational video on osteoporosis as well as written documentation on osteoporosis for the participant and the physician.
Interventions
Participants will receive written educational material for themselves as well as the Guidelines document for their physician (same written material as in the Educational Video Group). They will be asked to revisit their physician and provide written documentation inviting him/her to consider a complementary investigation and an adequate treatment according to the 2002 Clinical Practice Guidelines for the Diagnosis and Management of Osteoporosis in Canada
Participants will receive a 15-minute educational video on osteoporosis. They will also receive written educational material for themselves and a Guidelines document for their physician. They will be asked to revisit their physician and provide the written documentation inviting her/him to consider a complementary investigation and an adequate treatment according to the 2002 Clinical Practice Guidelines for the Diagnosis and Management of Osteoporosis in Canada. Should participants wish to obtain additional information on osteoporosis, they will be provided with a toll-free number (1-866-571-ROCQ) to contact
Eligibility Criteria
You may qualify if:
- Female, aged 50 years and over.
- Not residing in a long-term care hospital before the fracture.
- Able to understand the programme information and consent form.
- Must voluntarily accept to participate in this programme and sign the consent form.
- Participants must have a fragility or traumatic fracture of one of the following sites: wrist, forearm, humerus, scapula, clavicle, sternum, thoracic or lumbar vertebrae, pelvis, sacrum, hip, femur, proximal and distal tibia, fibula (including ankle), and foot.
- Participants must be able to answer the questionnaires via phone interviews
You may not qualify if:
- Unable to understand the purpose of the programme.
- Participants with a traumatic fracture of one of the following sites: cervical, skull and face, hand and finger, toe, metatarsus, and patella.
- Pathological fracture.
- Women currently participating in a clinical trial requiring them to take a medication for osteoporosis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CHU de Quebec-Universite Lavallead
- Merck Frosst Canada Ltd.collaborator
- Sanoficollaborator
- Procter and Gamblecollaborator
- Amgencollaborator
- Eli Lilly and Companycollaborator
- Novartiscollaborator
Study Sites (1)
CHUdeQuebec, CHUL
Québec, Quebec, G1V 4G2, Canada
Related Publications (6)
Bessette L, Ste-Marie LG, Jean S, Davison KS, Beaulieu M, Baranci M, Bessant J, Brown JP. Recognizing osteoporosis and its consequences in Quebec (ROCQ): background, rationale, and methods of an anti-fracture patient health-management programme. Contemp Clin Trials. 2008 Mar;29(2):194-210. doi: 10.1016/j.cct.2007.07.007. Epub 2007 Jul 24.
PMID: 17766187BACKGROUNDBessette L, Jean S, Davison KS, Roy S, Ste-Marie LG, Brown JP. Factors influencing the treatment of osteoporosis following fragility fracture. Osteoporos Int. 2009 Nov;20(11):1911-9. doi: 10.1007/s00198-009-0898-x. Epub 2009 Mar 31.
PMID: 19333675RESULTBeaudoin C, Bessette L, Jean S, Ste-Marie LG, Brown JP. The impact of educational interventions on modifiable risk factors for osteoporosis after a fragility fracture. Osteoporos Int. 2014 Jul;25(7):1821-30. doi: 10.1007/s00198-014-2618-4. Epub 2014 Feb 12.
PMID: 24519745RESULTBessette L, Jean S, Lapointe-Garant MP, Belzile EL, Davison KS, Ste-Marie LG, Brown JP. Direct medical costs attributable to peripheral fractures in Canadian post-menopausal women. Osteoporos Int. 2012 Jun;23(6):1757-68. doi: 10.1007/s00198-011-1785-9. Epub 2011 Sep 17.
PMID: 21927921RESULTBessette L, Davison KS, Jean S, Roy S, Ste-Marie LG, Brown JP. The impact of two educational interventions on osteoporosis diagnosis and treatment after fragility fracture: a population-based randomized controlled trial. Osteoporos Int. 2011 Dec;22(12):2963-72. doi: 10.1007/s00198-011-1533-1. Epub 2011 Feb 11.
PMID: 21311871RESULTBessette L, Ste-Marie LG, Jean S, Davison KS, Beaulieu M, Baranci M, Bessant J, Brown JP. The care gap in diagnosis and treatment of women with a fragility fracture. Osteoporos Int. 2008 Jan;19(1):79-86. doi: 10.1007/s00198-007-0426-9. Epub 2007 Jul 20.
PMID: 17641811RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacques P Brown, MD
CHU de Quebec
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical researcher
Study Record Dates
First Submitted
July 28, 2006
First Posted
August 1, 2006
Study Start
June 1, 2003
Primary Completion
October 1, 2007
Study Completion
December 1, 2025
Last Updated
November 21, 2017
Record last verified: 2017-11