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Studying how to choose treatment for spine fractures caused by osteoporosis

Observes people with osteoporosis-related spine fractures to guide treatment decisions.

Key facts

Who runs it
AO Foundation, AO Spine
Where
Burgdorf, SwitzerlandSee the siteAlso in 13 other countries, 14 sites
Trial code
Registry title
The Osteoporotic Fracture Classification-based Scoring System for Treatment Decision in Thoracolumbar Osteoporotic Fractures
Status
Recruiting
People taking part
648 people, planned
Started
19 Mar 2026
Expected to end
1 Dec 2030
Type of study
Observational, 2 groups
Treatments tested
  • Posterior stabilization (pedicle screws)
Record updated
13 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for postmenopausal women aged 50 or older and men older than 60 with a new, painful spine fracture in the chest or lower back, caused by primary osteoporosis.

Age
Women 50 years or older (after menopause); men older than 60 years.
Sex
Postmenopausal women and men.
Disease stage
New, painful fracture in the chest or lower back spine (T1 to L5), one level or several touching levels, caused by primary osteoporosis and classified OF 1 to OF 5 on imaging.
Earlier treatment
No earlier surgery with screws or rods at the affected spine levels. No other medical device or medicine study in the past month.
Biomarker or test result
Primary osteoporosis shown by a bone density T-score of -2.5 or lower, or by a fragility fracture (a break after no or low-energy trauma). The fracture is confirmed by MRI or CT.

Main reasons for not taking part

  • Spinal tumor or signs of spinal infection
  • Fracture from high-energy trauma, such as a fall from double body height or higher, or a serious car accident
  • Other broken bones in the pelvis, arms or legs that could affect pain or mobility
  • Bedridden before the fracture, or unable to follow the study procedures
  • No follow-up visits possible

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Switzerland

Also in 13 other countries, 14 sites

  • Spital Emmental - Orthopädie SonnenhofBurgdorf, SwitzerlandContact: Sebastian Bigdon, MDNot yet recruiting

About the trial

What the trial wants to find out

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).

The 2 groups in the trial

  • OF score accordance group

    Initial treatment decision in accordance with the OF score recommendations

    Treatment: Posterior stabilization (pedicle screws)

  • OF score discordance group

    Initial treatment decision in discordance with the OF score recommendations

    Treatment: Posterior stabilization (pedicle screws)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
The Osteoporotic Fracture Classification-based Scoring System for Treatment Decision in Thoracolumbar Osteoporotic Fractures: An International Multicenter Prospective Study
Plain-language title
Studying how to choose treatment for spine fractures caused by osteoporosisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
13 May 2026