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Recognizing Osteoporosis and Its Consequences in Quebec (ROCQ) Programme

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ClinicalTrials.gov Identifier: NCT00359047
Recruitment Status : Active, not recruiting
First Posted : August 1, 2006
Last Update Posted : November 21, 2017
Sponsor:
Collaborators:
Merck Frosst Canada Ltd.
Sanofi
Procter and Gamble
Amgen
Eli Lilly and Company
Novartis
Information provided by (Responsible Party):
Jacques Brown, CHU de Quebec-Universite Laval

Tracking Information
First Submitted Date  ICMJE July 28, 2006
First Posted Date  ICMJE August 1, 2006
Last Update Posted Date November 21, 2017
Study Start Date  ICMJE June 2003
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2008)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 28, 2006)
  • The present diagnostic and treatment rates of osteoporosis 6 months after a fragility fracture
  • The osteoporosis diagnostic rate and on the osteoporosis pharmacological treatment rate 12 months after the educational interventions
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2006)
  • Changes of modifiable risk factors for osteoporosis 12 months after the intervention
  • Incidence of fragility fractures in women 50 years and over
  • Proportion of fragility versus traumatic fractures.
  • Health care resource utilization associated with specific types of fragility fracture and recurrent fractures.
  • Assess health utility index (EQ-5D) after a fragility fracture.
  • Satisfaction with the process of care before and after implementing ROCQ's interventions.
  • One-year mortality rate following a fragility fracture.
  • Persistence to pharmacological treatment 12 months after the intervention
  • Incidence of recurrent fracture and health care resources utilization between women who previously had a fragility fracture and those who had a traumatic fracture.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Recognizing Osteoporosis and Its Consequences in Quebec (ROCQ) Programme
Official Title  ICMJE Recognizing Osteoporosis and Its Consequences in Quebec (ROCQ) Programme
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Osteoporosis
Intervention  ICMJE
  • Behavioral: Documentation
    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
  • Behavioral: Video
    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 Arms  ICMJE
  • Experimental: Documentation
    Written educational material on osteoporosis for the participant and the physician.
    Intervention: Behavioral: Documentation
  • Experimental: Video
    A 15-minute educational video on osteoporosis as well as written documentation on osteoporosis for the participant and the physician.
    Intervention: Behavioral: Video
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 15, 2008)
2830
Original Enrollment  ICMJE
 (submitted: July 28, 2006)
3000
Estimated Study Completion Date  ICMJE December 2025
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00359047
Other Study ID Numbers  ICMJE CHUL 61.05.05
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jacques Brown, CHU de Quebec-Universite Laval
Study Sponsor  ICMJE CHU de Quebec-Universite Laval
Collaborators  ICMJE
  • Merck Frosst Canada Ltd.
  • Sanofi
  • Procter and Gamble
  • Amgen
  • Eli Lilly and Company
  • Novartis
Investigators  ICMJE
Principal Investigator: Jacques P Brown, MD CHU de Quebec
PRS Account CHU de Quebec-Universite Laval
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP