Osteoporosis Clinical Trial
Official title:
Recognizing Osteoporosis and Its Consequences in Quebec (ROCQ) Programme
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.
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.
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