Recognizing Osteoporosis and Its Consequences in Quebec (ROCQ) Programme

Osteoporosis Clinical Trial

Official title:

Recognizing Osteoporosis and Its Consequences in Quebec (ROCQ) Programme

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00359047
• Other study ID #: CHUL 61.05.05
• Status: Active, not recruiting
• Phase: N/A
• First received: July 28, 2006
• Last updated: November 17, 2017
• Start date: June 2003
• Est. completion date: December 2025

Study information

• Verified date: November 2017
• Source: CHU de Quebec-Universite Laval
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2830
• Est. completion date: December 2025
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoporosis

Intervention

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
• 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

Locations

Country	Name	City	State
Canada	CHUdeQuebec, CHUL	Quebec

Sponsors (7)

Lead Sponsor	Collaborator
CHU de Quebec-Universite Laval	Amgen, Eli Lilly and Company, Merck Frosst Canada Ltd., Novartis, Procter and Gamble, Sanofi

Country where clinical trial is conducted

Canada, 

References & Publications (6)

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 1 — View 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):29 — View 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. — View 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. Ep — View 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. Epub 2007 Jul 24. — View 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. Epub 2007 Jul 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The present diagnostic and treatment rates of osteoporosis 6 months after a fragility fracture		June 2007
Primary	The osteoporosis diagnostic rate and on the osteoporosis pharmacological treatment rate 12 months after the educational interventions		June 2007
Primary	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	Changes of modifiable risk factors for osteoporosis 12 months after the intervention		September 2009
Secondary	Proportion of fragility versus traumatic fractures.		June 2007
Secondary	Health care resource utilization associated with specific types of fragility fracture and recurrent fractures.		September 2010
Secondary	Assess health utility index (EQ-5D) after a fragility fracture.		September 2010
Secondary	Satisfaction with the process of care before and after implementing ROCQ's interventions.		June 2010
Secondary	One-year mortality rate following a fragility fracture.		May 2009
Secondary	Persistence to pharmacological treatment 12 months after the intervention		October 2009
Secondary	Incidence of recurrent fracture and health care resources utilization between women who previously had a fragility fracture and those who had a traumatic fracture.		November 2010