OsteoporosisNCT00359047
Recognizing Osteoporosis and Its Consequences in Quebec (ROCQ) Programme
A study testing Documentation and Video in people with Osteoporosis, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Documentation and Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,830 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2003to Dec 2025
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
ROCQ is a patient health-management programme and prospective cohort study. Within the ROCQ programme, educational interventions to improve osteoporosis management will be evaluated using a randomized-control design. The programme is composed of a promotional campaign, three main phases and a 20-year follow-up.
At phase 1, 0 to 16 weeks after the fracture, participants with fragility and traumatic fractures will be recruited and will be asked information regarding their fracture.
At phase 2, 6 to 8 months after the fracture, all participants will complete questionnaires to evaluate demographic and clinical features, risk factors for osteoporosis, co-morbidities, status of diagnosis and treatment, and the EQ-5D. The current medical management of osteoporosis (or the care gap in diagnosis and treatment) will be measured using this questionnaire at phase 2. Once the phase 2 questionnaire has been completed, Only participants with fragility fractures will be randomized to one of the three following educational intervention groups: 1) the Educational Video Group, 2) the Documentation Group, or 3) the Control Group.
At phase 3, 12 to 14 months after randomization, the effectiveness of the interventions will be assessed by re-administering the questionnaires to participants who experienced a fragility fracture at baseline. The questionnaires evaluate the status of diagnosis and treatment of osteoporosis, modifiable risk factors and the health-related quality of life (EQ-5D). The impact of the interventions on the participants will be assessed by comparing diagnosis and treatments rates in each intervention arm.
If the long-term viability of the programme is secured, participants with fragility and traumatic fractures will be followed for a maximum period of 20 years using specific encoded personal data contained in the RAMQ and Quebec's drug plan databases.
- Conditions
- Osteoporosis
- Being tested
- Documentation, Video
- Keywords
- Osteoporosis, Fragility fracture, Women, Randomised control trial, Patient education, Diagnosis, Treatment
- Medical subject headings
- Osteoporosis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocumentationBehavioural
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
VideoBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Documentation | Experimental | Written educational material on osteoporosis for the participant and the physician. Receives: Behavioral: Documentation |
| Video | Experimental | A 15-minute educational video on osteoporosis as well as written documentation on osteoporosis for the participant and the physician. Receives: Behavioral: Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
The present diagnostic and treatment rates of osteoporosis 6 months after a fragility fracture
Measured: June 2007
The osteoporosis diagnostic rate and on the osteoporosis pharmacological treatment rate 12 months after the educational interventions
Measured: 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.
Measured: July 2009
Secondary outcomes (8)
Changes of modifiable risk factors for osteoporosis 12 months after the intervention
Measured: September 2009
Proportion of fragility versus traumatic fractures.
Measured: June 2007
Health care resource utilization associated with specific types of fragility fracture and recurrent fractures.
Measured: September 2010
Assess health utility index (EQ-5D) after a fragility fracture.
Measured: September 2010
Satisfaction with the process of care before and after implementing ROCQ's interventions.
Measured: June 2010
One-year mortality rate following a fragility fracture.
Measured: May 2009
Persistence to pharmacological treatment 12 months after the intervention
Measured: October 2009
Incidence of recurrent fracture and health care resources utilization between women who previously had a fragility fracture and those who had a traumatic fracture.
Measured: November 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2006 (estimated)
- Study startJun 2003
- Primary completionOct 2007
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,830 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Frosst Canada Ltd., Sanofi, Procter and Gamble, Amgen, Eli Lilly and Company, Novartis
- Responsible party
- Principal investigator, Jacques Brown, CHU de Quebec-Universite Laval
- Investigators
- Jacques P Brown, MD, Principal investigator, CHU de Quebec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00359047
- Sponsor's protocol ID
- CHUL 61.05.05
- Status last verified
- Nov 2017
- First submitted
- 28 Jul 2006
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17766187Bessette 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.
PubMed 19333675Beaudoin 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.
PubMed 24519745Bessette 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.
PubMed 21927921Bessette 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.
PubMed 21311871Bessette 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.
PubMed 17641811
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recognizing Osteoporosis and Its Consequences in Quebec (ROCQ) Programme
- ClinicalTrials.gov ID
- NCT00359047
- Acronym / sponsor ID
- CHUL 61.05.05
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis, Fragility fracture, Women, Randomised control trial, Patient education, Diagnosis, Treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,830 participants (actual)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Collaborators
- Merck Frosst Canada Ltd., Sanofi, Procter and Gamble, Amgen, Eli Lilly and Company, Novartis
- Study start
- Jun 2003
- Primary completion
- Oct 2007 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 1 Aug 2006 (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.
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.
Detailed description
ROCQ is a patient health-management programme and prospective cohort study. Within the ROCQ programme, educational interventions to improve osteoporosis management will be evaluated using a randomized-control design. The programme is composed of a promotional campaign, three main phases and a 20-year follow-up.
At phase 1, 0 to 16 weeks after the fracture, participants with fragility and traumatic fractures will be recruited and will be asked information regarding their fracture.
At phase 2, 6 to 8 months after the fracture, all participants will complete questionnaires to evaluate demographic and clinical features, risk factors for osteoporosis, co-morbidities, status of diagnosis and treatment, and the EQ-5D. The current medical management of osteoporosis (or the care gap in diagnosis and treatment) will be measured using this questionnaire at phase 2. Once the phase 2 questionnaire has been completed, Only participants with fragility fractures will be randomized to one of the three following educational intervention groups: 1) the Educational Video Group, 2) the Documentation Group, or 3) the Control Group.
At phase 3, 12 to 14 months after randomization, the effectiveness of the interventions will be assessed by re-administering the questionnaires to participants who experienced a fragility fracture at baseline. The questionnaires evaluate the status of diagnosis and treatment of osteoporosis, modifiable risk factors and the health-related quality of life (EQ-5D). The impact of the interventions on the participants will be assessed by comparing diagnosis and treatments rates in each intervention arm.
If the long-term viability of the programme is secured, participants with fragility and traumatic fractures will be followed for a maximum period of 20 years using specific encoded personal data contained in the RAMQ and Quebec's drug plan databases.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Documentation | Experimental | Behavioral: DocumentationWritten educational material on osteoporosis for the participant and the physician. |
| Video | Experimental | Behavioral: VideoA 15-minute educational video on osteoporosis as well as written documentation on osteoporosis for the participant and the physician. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| DocumentationParticipants 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 | Behavioural | Documentation |
| VideoParticipants 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 | Behavioural | Video |
Primary outcome
The present diagnostic and treatment rates of osteoporosis 6 months after a fragility fracture
Time frame: June 2007
The osteoporosis diagnostic rate and on the osteoporosis pharmacological treatment rate 12 months after the educational interventions
Time frame: 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.
Time frame: July 2009
8 secondary outcomes
Changes of modifiable risk factors for osteoporosis 12 months after the intervention
Time frame: September 2009
Proportion of fragility versus traumatic fractures.
Time frame: June 2007
Health care resource utilization associated with specific types of fragility fracture and recurrent fractures.
Time frame: September 2010
Assess health utility index (EQ-5D) after a fragility fracture.
Time frame: September 2010
Satisfaction with the process of care before and after implementing ROCQ's interventions.
Time frame: June 2010
One-year mortality rate following a fragility fracture.
Time frame: May 2009
Persistence to pharmacological treatment 12 months after the intervention
Time frame: October 2009
Incidence of recurrent fracture and health care resources utilization between women who previously had a fragility fracture and those who had a traumatic fracture.
Time frame: November 2010
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2017.
- Background: PubMed 17766187Bessette 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.
- Results publication: PubMed 19333675Bessette 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.
- Results publication: PubMed 24519745Beaudoin 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.
- Results publication: PubMed 21927921Bessette 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.
- Results publication: PubMed 21311871Bessette 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.
- Results publication: PubMed 17641811Bessette 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.
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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.
Jacques P Brown, MD principal investigator
CHU de Quebec
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Documentation and Video in people with Osteoporosis, run by CHU de Quebec-Universite Laval at 1 site 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 6 inclusion and 4 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 21 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The present diagnostic and treatment rates of osteoporosis 6 months after a fragility fracture (time frame: June 2007). The study lists 3 primary outcomes in all. 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 NCT00359047, which also lists 6 linked publications.
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 21 Nov 2017.