Studying how to choose treatment for spine fractures caused by osteoporosis
Observes people with osteoporosis-related spine fractures to guide treatment decisions.
Plain-language title generated from the registry record
Registry title: The Osteoporotic Fracture Classification-based Scoring System for Treatment Decision in Thoracolumbar Osteoporotic Fractures
Key facts
- Where
- Philadelphia and San Francisco, United StatesSee the 2 sites
Where in United States
- Thomas Jefferson University HospitalPhiladelphia, United StatesNot yet recruiting
- University of California San Francisco (USCF) Department of Orthopaedic SurgerySan Francisco, United StatesNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AO Foundation, AO Spine
- Trial code
- NCT07027306
- Record updated
- 13 May 2026
- Original description
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).Read full original descriptionShow less
The Osteoporotic Fracture Classification-based Scoring System for Treatment Decision in Thoracolumbar Osteoporotic Fractures: An International Multicenter Prospective Study
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).
Inclusion: 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 2: Deformation of one endplate; OF 3: Deformation of one endplate with distinct posterior wall involvement; OF 4: Deformation of both endplates with/without posterior wall involvement; OF 5: Injuries with anterior or posterior tension band failure; Ability to provide informed consent according to the EC/IRB defined and approved procedures.
Exclusion: Patients with concomitant cervical fractures; Patients with concomitant fracture in the pelvis, upper extremities, and/or lower extremities which could affect the main study outcomes (specifically, patient mobility and pain); Previous instrumented surgery in the affected spine levels; Patients with single-level fracture or contiguous multilevel fracture adjacent to previous instrumented surgery; Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study; Patients showing any signs of spinal infections; Recent history of substance abuse (ie, recreational drugs and alcohol) that would preclude reliable assessments; Patients with spinal tumors; Patients with fractures due to high-energy or high-impact trauma, eg, a fall from double the body height or higher, motor vehicle accident with > 100 km/h in cars with airbags, or motor vehicle accident > 50 km/h without airbags, polytrauma; Patients for whom no FUs are possible; Patients who are mentally impaired and therefore not able to adhere to the study procedures and data collection; Patients who are bedridden before the index fracture.