The Osteoporotic Fracture Classification-based Scoring System for Treatment Decision in Thoracolu… (NCT07027306) | Clinical Trial Compass
RecruitingNot Applicable
The Osteoporotic Fracture Classification-based Scoring System for Treatment Decision in Thoracolumbar Osteoporotic Fractures
United States, Argentina, Brazil648 participantsStarted 2026-03-10
Plain-language summary
This is an international multicenter prospective observational study. Patients with radiologically confirmed, symptomatic, single- or multilevel contiguous TL (from T1 to L5) fractures as a result of primary osteoporosis will be recruited from participating clinics/hospitals (ie, study sites). Fractures included are insufficiency fractures (confirmed by magnetic resonance imaging \[MRI\]) and traumatic fractures (low-energy trauma, confirmed by computed tomography \[CT\] or MRI).
Who can participate
Age range50 Years
SexALL
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:
* Postmenopausal women ≥ 50 years old or men \> 60 years old
o Menopause refers to amenorrhea for 1 complete year.
* Radiologically confirmed new diagnosis of symptomatic, single or multilevel TL (from T1 to L5) fractures, ie, the index fracture(s).
* In case of a multilevel fracture, the fracture must be contiguous.
* The index fracture is confirmed by MRI as an insufficiency (or fragility) fracture or is confirmed by CT or MRI as traumatic fracture (low-energy trauma)
* The index fracture(s) is a result of primary osteoporosis. Diagnosis of primary osteoporosis is based on any of the followings in the absence of causes for secondary osteoporosis (such as long-term use of steroids, rheumatoid arthritis, type 1 diabetes mellitus \[DM\], and other metabolic bone disorders \[eg, rickets/osteomalacia, Paget's disease, osteogenesis imperfecta, and primary hyperparathyroidism\]) \[13-15\]:
* A T-score ≤ -2.5 in the lumbar spine, femoral neck, total hip, or 1/3 radius
* Presence of fragility fracture (either a previous fragility fracture or the index fracture is a fragility fracture). Fragility fractures are fractures due to no or low-energy trauma, eg, slips, trips, or falls from less than double the body height, and heavy lifting.
* The index osteoporotic TL fracture being classified based on the OF Classification from OF 1 to OF 5:
* OF 1: No deformation (vertebral body edema on MRI using short tau inversion recovery \[STIR\] sequence)
* OF…
What they're measuring
1
Return to mobility
Timeframe: From day of treatment to the end of the first 3 months after treatment.