Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-24 @ 9:15 PM
NCT ID:
NCT03967704
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03967704
Study Brief:
Protocol Section:
NCT03967704