RecruitingOBSERVATIONAL

The Osteoporotic Fracture Classification-based Scoring System for Treatment Decision in Thoracolumbar Osteoporotic Fractures

This international study is observing how doctors treat broken bones in the back that are caused by osteoporosis, a condition where bones become weak. Researchers are using a new scoring system to help doctors decide if surgery (like using screws to stabilise the spine) or non-surgical treatment is best. The study will look at women over 50 and men over 60 who have these types of back fractures. Patients will be grouped based on whether their doctors' treatment choices match the recommendations of the scoring system. This helps understand if the scoring system leads to better treatment decisions and outcomes for people with fragile bones in their spine.

At a glance

Status

Recruiting

Sponsor

AO Foundation, AO Spine

Enrolment target

648

Start

19 Mar 2026

Estimated completion

01 Dec 2030

Osteoporotic Fractures Osteoporosis

What is this study about?

This study is about understanding how to make the best treatment choices for people who have broken bones in their back because of osteoporosis. Osteoporosis makes bones weak and more likely to break, even from a small knock or fall. These types of breaks, called osteoporotic fractures, can be very painful and make everyday life difficult.

Researchers are using a new tool called the OF Classification system. Think of it like a helpful guide that gives a score to each fracture based on how severe it is. This score helps doctors decide whether a patient might benefit more from surgery (like using special screws to support the spinal bones) or from non-surgical treatments (which could include pain management, physical therapy, or bracing). The main goal of the study is to see if using this scoring system helps doctors make better decisions for their patients.

Doctors taking part will treat their patients as they normally would, but the study will note whether their decision aligns with the OF score's recommendation. By comparing the experiences of patients whose treatment matched the score with those whose treatment didn't, the study hopes to find out if this new scoring system can improve care for people with these difficult-to-treat back fractures.

Key takeaways

The study helps doctors make better decisions for back fractures caused by osteoporosis.
It uses a new scoring system to guide treatment choices.
Participation involves receiving your usual medical care, with the study collecting information.
It's open to women over 50 and men over 60 with specific back fractures.
Your standard treatment won't change because of participating.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for women aged 50 and over, and men aged 60 and over. To be considered, you must have broken bones in your middle or lower back (between T1 and L5) due to osteoporosis. These breaks should be newly diagnosed and causing you symptoms.

The breaks can be due to very minor incidents, sometimes called 'fragility fractures', or from a low-energy injury like a fall from standing height. Doctors will have confirmed these fractures using scans like MRI or CT scans. You'll also need to be able to understand the study and agree to take part.

However, you won't be able to join if you have cancer that has spread to your spine, if you have other broken bones in your neck, or if there are any signs of infection in your spine.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman aged 50 or older, or a man aged 60 or older?
Have you recently been diagnosed with a broken bone in your middle or lower back that is causing you pain?
Did your doctor confirm this break is due to osteoporosis, perhaps from a small fall or no obvious injury?
Do you not have cancer in your spine, a neck fracture, or a spinal infection?

Answer every question to see your result.

What does participation involve?

If you take part in this study, the doctors will treat your broken back bones as they usually would. The study is mainly about observing and recording how decisions are made, particularly using the new scoring system. You won't receive different treatments than what your doctor would normally recommend. You will have regular appointments and scans as part of your standard care, and the study will collect information from these visits. The exact number of visits or the total length of your participation isn't specified, but it will involve follow-up to see how your treatment progresses.

Potential risks and benefits

Taking part in this study may offer the benefit of contributing to new knowledge that could improve treatments for people with similar back fractures in the future. As this is an observational study, you will receive standard medical care, meaning the risks are generally associated with your usual treatment rather than the study itself. However, as with any medical situation, there are always inherent risks to treatment options. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (15)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of California San Francisco (USCF) Department of Orthopaedic Surgery
Verified postcode
San Francisco, United States· Not yet recruiting
Thomas Jefferson University Hospital
Verified postcode
Philadelphia, United States· Not yet recruiting
Sanatorio Güemes
Verified postcode
Buenos Aires, Argentina· Not yet recruiting
Cajuru University Hospital
Verified postcode
Curitiba, Brazil· Not yet recruiting
Department of Orthopedic Surgery, Clinica Alemana de Santiago
Verified postcode
Santiago, Chile· Not yet recruiting
Orthopaedic Department, Assiut University Hospitals, Faculty of Medicine
Verified postcode
Asyut, Egypt· Not yet recruiting
Tampere University Hospital
Verified postcode
Tampere, Finland· Not yet recruiting
Center for Spinal and Scoliosis Surgery, Malteser Waldkrankenhaus St. Marien
Verified postcode
Erlangen, Germany· Not yet recruiting
PGIMER - Postgraduate Institute of Medical Education and Research
Verified postcode
Chandigarh, India· Not yet recruiting
Dokkyo Medical University Hospital
Verified postcode
Tochigi, Japan· Not yet recruiting
Island Hospital Spine Centre
Verified postcode
George Town, Malaysia· Recruiting
Spiatlul Clinic De Urgenta, "Profesor Doctor Nicolae Oblu"
Verified postcode
Iași, Romania· Recruiting

Common questions

What is osteoporosis?

Osteoporosis is a condition that makes your bones weak and more likely to break, often from minor bumps or falls.

What kind of broken bones are being studied?

This study focuses on broken bones in the middle and lower part of your back (your spine) that are caused by osteoporosis.

Will I get a special treatment in this study?

No, you will receive the usual care your doctor believes is best for you. The study is observing how treatment decisions are made.

What is the 'scoring system' mentioned?

It's a new guide for doctors to help them decide if surgery or other treatments would be most suitable for your type of fracture.

Can I leave the study if I change my mind?

Yes, you can choose to stop participating at any time, and it won't affect the medical care you receive.

How to find out more

Felix Thomas Thomas, PhD

felix.thomas@aofoundation.org +41 79 671 47 98 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.