Clinical trial NCT00359047: Recognizing Osteoporosis and Its Consequences in Quebec (ROCQ) Programme
Official title: Recognizing Osteoporosis and Its Consequences in Quebec (ROCQ) Programme
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteoporosis
Keywords: Osteoporosis
Fragility fracture
Women
Randomised control trial
Patient education
Diagnosis
Treatment
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
Collaborators: name: Merck Frosst Canada Ltd.
name: Sanofi
name: Procter and Gamble
name: Amgen
name: Eli Lilly and Company
name: Novartis
First posted: 2006-08-01
Enrollment: 2830
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The present diagnostic and treatment rates of osteoporosis 6 months after a fragility fracture
timeFrame: June 2007
measure: The osteoporosis diagnostic rate and on the osteoporosis pharmacological treatment rate 12 months after the educational interventions
timeFrame: June 2007
measure: 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.
timeFrame: July 2009
Secondary outcomes:
measure: Changes of modifiable risk factors for osteoporosis 12 months after the intervention
timeFrame: September 2009
measure: Proportion of fragility versus traumatic fractures.
timeFrame: June 2007
measure: Health care resource utilization associated with specific types of fragility fracture and recurrent fractures.
timeFrame: September 2010
measure: Assess health utility index (EQ-5D) after a fragility fracture.
timeFrame: September 2010
measure: Satisfaction with the process of care before and after implementing ROCQ's interventions.
timeFrame: June 2010
measure: One-year mortality rate following a fragility fracture.
timeFrame: May 2009
measure: Persistence to pharmacological treatment 12 months after the intervention
timeFrame: October 2009
measure: Incidence of recurrent fracture and health care resources utilization between women who previously had a fragility fracture and those who had a traumatic fracture.
timeFrame: November 2010
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: CHUdeQuebec, CHUL
Study officials:
affiliation: CHU de Quebec
name: Jacques P Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Bessette 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.
citation: Beaudoin 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.
citation: Bessette 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.
citation: Bessette 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.
citation: Bessette 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.