Optimization of Follow-up of Patients With Symptomatic Recent Osteoporotic Vertebral Fracture (NCT03967704) | Clinical Trial Compass
CompletedNot Applicable
Optimization of Follow-up of Patients With Symptomatic Recent Osteoporotic Vertebral Fracture
France39 participantsStarted 2019-01-08
Plain-language summary
The management of osteoporotic fractures has recently changed with the emergence of new programs dedicated to the diagnosis and treatment of osteoporosis. For example, the Fracture Network of the Paris Saint-Joseph Hospital Group, created in 2015, identifies and ensures the care of patients who have consulted emergency rooms for osteoporotic fractures. Within this sector, the vertebral fracture (VF) appears to be the most frequent (22.4%) ahead of other fracture sites, confirming the results of other studies that consider VF as a real public health problem.
Osteoporotic vertebral fractures (OVF) have certain specificities compared to other osteoporotic fractures, encouraging particular interest.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient \> 18 years old
* Patient consulting or hospitalized in the rheumatology department at the GHPSJ for recent and symptomatic osteoporotic spinal or lumbar fracture Recentness is defined either by anamnestic event existence (example: fall) to date the fracture less than 4 months old, or by MRI or CT signs existence of attesting to recent nature of the fracture: hypersignal T2 stir \& hyposignal T1 on MRI, presence of a cleft on the CT, on imaging less than 4 months old.
Symptomatic is defined as spinal pain existence in relation to the vertebral fracture, not attributable to any cause other than the fracture.
* Patient affiliated to a health insurance plan
* Patient capable of giving free, informed and express consent
Exclusion Criteria:
* Patient with fractures occurring on metastatic spine
* Patient with unstable VF, requiring rapid orthopedic management
* Patient with a history of cementoplasty on dorsal or lumbar spine
* Patients transferred to another hospital after transition to SAU
* Homeless patient
* Patient not residing in Ile-de-France
* Patient who is bedridden or has one or more severe co-morbidity(s) that puts fractured osteoporosis in background
* Patient deprived of liberty
* Patient under guardianship or curators
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assess life quality of patients with osteoporotic VF 12 months after symptomatic vertebral fracture diagnosis: Quality of life questionnaires (QUALEFFO-41)