Educational Interventions for Osteoporosis
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are already in a trial that requires you to take osteoporosis medication, you cannot participate in this one.
What data supports the effectiveness of the treatment Documentation, Video, Mindfulness-Based Cognitive Therapy, MBCT for osteoporosis?
Research shows that patient education, including mindfulness and medical yoga, can improve pain and quality of life in people with spinal osteoporosis. Additionally, complex interventions that include education and follow-up significantly increase osteoporosis investigations and treatment initiation.12345
Is patient education for osteoporosis safe for humans?
How does the educational intervention for osteoporosis differ from other treatments?
This educational intervention is unique because it focuses on increasing knowledge about osteoporosis, promoting self-care, and encouraging healthy behaviors like proper calcium and vitamin D intake, rather than relying on medication. It involves group or individual sessions that empower participants to manage their condition through lifestyle changes and improved understanding of the disease.7891011
What is the purpose of this trial?
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.
Research Team
Jacques P Brown, MD
Principal Investigator
CHU de Quebec
Eligibility Criteria
This trial is for women aged 50 or older who have had a fragility fracture, can understand the study information and consent form, agree to participate voluntarily, and are able to complete questionnaires over the phone. It excludes those already in a clinical trial for osteoporosis medication, unable to grasp the programme's purpose, or with fractures due to severe trauma or disease.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Phase 1
Participants with fragility and traumatic fractures are recruited and asked information regarding their fracture
Phase 2
Participants complete questionnaires to evaluate demographic and clinical features, risk factors for osteoporosis, co-morbidities, status of diagnosis and treatment, and the EQ-5D
Phase 3
Effectiveness of the interventions is assessed by re-administering the questionnaires to participants who experienced a fragility fracture at baseline
Follow-up
Participants with fragility and traumatic fractures will be followed for a maximum period of 20 years using specific encoded personal data
Treatment Details
Interventions
- Documentation
- Video
Find a Clinic Near You
Who Is Running the Clinical Trial?
CHU de Quebec-Universite Laval
Lead Sponsor
Merck Frosst Canada Ltd.
Industry Sponsor
Amgen
Industry Sponsor
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London
Eli Lilly and Company
Industry Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University
Sanofi
Industry Sponsor
Paul Hudson
Sanofi
Chief Executive Officer since 2019
Degree in Economics from Manchester Metropolitan University
Christopher Corsico
Sanofi
Chief Medical Officer
MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University
Procter and Gamble
Industry Sponsor
Marc Pritchard
Procter and Gamble
Chief Marketing Officer since 2008
B.S. in Finance from Indiana University, Bloomington
Jon R. Moeller
Procter and Gamble
Chief Executive Officer since 2021
MBA from Cornell University, B.S. in Biology from Cornell University
Novartis
Industry Sponsor
Vasant Narasimhan
Novartis
Chief Executive Officer since 2018
MD from Harvard Medical School, Bachelor's in Biological Sciences from University of Chicago, Master's in Public Policy from John F. Kennedy School of Government
Shreeram Aradhye
Novartis
Chief Medical Officer since 2022
MD from Yale University, MSc in Clinical Epidemiology from University of Pennsylvania