Educational Interventions for Osteoporosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests new methods to educate women about osteoporosis, a condition where bones weaken and are more prone to fractures. It aims to improve the use of osteoporosis treatments for women over 50 who have experienced a bone break from a minor fall or bump. Participants will receive either written materials (Documentation) or a video (Mindfulness-Based Cognitive Therapy, MBCT), along with written information, to assist them and their doctors in making better treatment decisions. Women who have recently experienced a bone break in areas such as the wrist, hip, or spine and can participate in phone interviews are well-suited for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative educational approaches that could enhance osteoporosis care for many women.
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 prior data suggests that these educational interventions are safe for participants?
Research has shown that educational tools like videos and written materials are generally very safe, with no evidence indicating harm to participants. This trial aims to use educational resources to help women over 50 better understand and manage osteoporosis after a bone fracture. The treatments being tested include reading materials and videos. Unlike medications or surgeries, these methods do not involve any physical risks. In summary, the educational methods in this trial are well-tolerated and have no known safety concerns.12
Why are researchers excited about this trial?
Researchers are excited about these educational interventions for osteoporosis because they aim to enhance both patient and physician understanding of the condition, which is a fresh approach compared to standard drug treatments like bisphosphonates or hormone therapy. The interventions include written documentation and a 15-minute video, offering a more engaging way to learn about osteoporosis. This educational method could empower patients with knowledge, potentially leading to better disease management and decision-making without relying solely on medication. By improving education, these interventions may complement existing treatments and lead to better overall outcomes for those affected by osteoporosis.
What evidence suggests that this trial's educational interventions could be effective for osteoporosis?
This trial will compare two educational interventions for osteoporosis: written documentation and a video. Studies have shown that educational programs can enhance understanding and management of osteoporosis. Research indicates that clear educational materials, such as videos or written guides, often improve patients' knowledge of their condition. This improved understanding can lead to better adherence to treatment plans. A review suggests that incorporating learning science principles into educational materials can effectively increase knowledge about osteoporosis. Consequently, these tools might help women who have had fractures better understand osteoporosis and adhere more closely to their treatment plans.23456
Who Is on the Research Team?
Jacques P Brown, MD
Principal Investigator
CHU de Quebec
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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