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New scoring system aims to help osteoporosis patients walk again faster after spine fractures

NCT ID NCT07027306

Knowledge-focused Sponsor: AO Foundation, AO Spine Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a new scoring system (called the OF score) helps doctors choose the best treatment for people with spine fractures due to osteoporosis. About 648 adults over 50 will be observed to see if following the score's advice leads to faster return to normal mobility within 3 months. The goal is to improve recovery without testing any new drugs or surgeries.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 648 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Postmenopausal women ≥ 50 years old or men \> 60 years old

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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 Criteria: * Patients with spinal tumors * Patients with concomitant cervical fractures * Patients showing any signs of spinal infections * 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 with concomitant fracture in the pelvis, upper extremities, and/or lower extremities which could affect the main study outcomes (specifically, patient mobility and pain) * Patients for whom no FUs are possible * Previous instrumented surgery in the affected spine levels * Patients with single-level fracture or contiguous multilevel fracture adjacent to previous instrumented surgery * 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 * Recent history of substance abuse (ie, recreational drugs and alcohol) that would preclude reliable assessments * Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study

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Conditions

The condition(s) this trial relates to.

osteoporosis Osteoporotic Fractures

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Osteoporosis Osteoporotic fractures

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites in 14 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cajuru University Hospital

    NOT_YET_RECRUITING

    Curitiba, 80050-50, Brazil

  • Center for Spinal and Scoliosis Surgery, Malteser Waldkrankenhaus St. Marien

    NOT_YET_RECRUITING

    Erlangen, 91054, Germany

  • Department of Orthopedic Surgery, Clinica Alemana de Santiago

    NOT_YET_RECRUITING

    Santiago, 5951, Chile

  • Dokkyo Medical University Hospital

    NOT_YET_RECRUITING

    Tochigi, 321-0293, Japan

  • Island Hospital Spine Centre

    RECRUITING

    George Town, 10450, Malaysia

  • King's College Hospital

    NOT_YET_RECRUITING

    London, SE5 9RS, United Kingdom

  • Orthopaedic Department, Assiut University Hospitals, Faculty of Medicine

    NOT_YET_RECRUITING

    Asyut, 71526, Egypt

  • PGIMER - Postgraduate Institute of Medical Education and Research

    NOT_YET_RECRUITING

    Chandigarh, 160 012, India

  • Sanatorio Güemes

    NOT_YET_RECRUITING

    Buenos Aires, 1240, Argentina

  • Security Force Hospital

    RECRUITING

    Riyāḑ, 11564, Saudi Arabia

  • Spiatlul Clinic De Urgenta, "Profesor Doctor Nicolae Oblu"

    RECRUITING

    Iași, 700309, Romania

  • Spital Emmental - Orthopädie Sonnenhof

    NOT_YET_RECRUITING

    Burgdorf, 3400, Switzerland

  • Tampere University Hospital

    NOT_YET_RECRUITING

    Tampere, 33521, Finland

  • Thomas Jefferson University Hospital

    NOT_YET_RECRUITING

    Philadelphia, Pennsylvania, 19107-4216, United States

  • University of California San Francisco (USCF) Department of Orthopaedic Surgery

    NOT_YET_RECRUITING

    San Francisco, California, 94143-0728, United States

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