Active not recruitingOBSERVATIONAL

Evaluation of IVA (SE Femur Scans) to Identify Incomplete AFFs

This research is investigating a new way to find early, hidden cracks in the main thigh bone (femur). These cracks are called Atypical Femur Fractures (AFFs) and can be quite serious. Researchers want to see if a special type of bone density scan, called a DXA scan (specifically the SE Femur scan mode), can be used to spot these incomplete fractures. Normally, DXA scans check bone strength for osteoporosis, but this study explores using the same technology for something different. The goal is to find a simple, low-radiation way to screen for these breaks in people who are already known to have them, or in those who might be at higher risk, such as individuals who have been on certain bone-strengthening medications for five years or more and have unexplained leg pain.

At a glance

Status

Active not recruiting

Sponsor

University Health Network, Toronto

Enrolment target

285

Start

01 Jul 2012

Estimated completion

01 Dec 2026

Atypical Femur Fracture

What is this study about?

Imagine your thigh bone developing a tiny, almost invisible crack that could eventually lead to a bigger, more serious break. That's what an "incomplete atypical femur fracture" (AFF) is. These aren't your typical broken bones from a fall; they're very specific and sometimes linked to long-term use of certain medicines designed to strengthen bones.

Currently, it can be tricky to find these tiny cracks before they cause major problems. Doctors often use DXA scanners to check how strong your bones are, especially if you have osteoporosis. These scanners use very low levels of radiation, much less than a standard X-ray. Some DXA scanners have a clever feature that can take detailed pictures of your spine to find hidden fractures there, and this is called an Instant Vertebral Assessment (IVA) or more recently, HD-IVA. This study asks: can we use a similar setting on the DXA scanner, now called SE Femur scans, to look for these tiny cracks in your thigh bone?

This research aims to see if these special DXA scans can be a good, easy and safe way to find these early cracks in people who are at risk. If successful, it could mean that people who are taking certain bone medications or experiencing unexplained leg pain could have a simple scan to check for these fractures before they become a bigger problem.

Key takeaways

The study uses a special DXA scan (SE Femur scan) to look for early thigh bone cracks.
It aims to find a simple, low-radiation way to screen for Atypical Femur Fractures (AFFs).
Looks at women aged 18-100 who either have an AFF or are at risk.
Being at risk means taking certain bone medications for 5+ years with unexplained leg pain.
Participation likely involves one or more special DXA scans.
The study has minimal known risks due to low radiation from DXA scans.

Who may be eligible?

This study is looking for two main groups of women aged 18 to 100 years old. Firstly, they are looking for women who have already been diagnosed with an incomplete atypical fracture in their thigh bone and are patients at the UHN osteoporosis clinic.

Secondly, they are looking for women who are already scheduled to have a bone density scan at UHN. Within this second group, you would need to have been taking certain bone-strengthening medications (called bisphosphonates) for five years or more, and you should also be experiencing some unexplained pain in your leg, hip, thigh, or knee.

There are no reasons listed that would prevent you from taking part in this study if you fit one of these groups.

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 between 18 and 100 years old?
Are you a woman?
Have you been diagnosed with an incomplete atypical thigh bone fracture and are a patient at UHN?
OR, are you scheduled for a bone density scan at UHN?
AND, have you been taking bisphosphonate medication for 5 years or more?
AND, do you have unexplained pain in your leg, hip, thigh, or knee?

Answer every question to see your result.

What does participation involve?

The details of what participation involves are not fully described in the information provided. However, based on the study's aim to use DXA scans, it is likely that taking part would involve having at least one special DXA scan of your thigh bone at UHN. If you are in the comparison group, this scan might be done at the same time as your routine bone density scan. The duration of your involvement in the study, including any follow-up, is not specified.

Potential risks and benefits

Potential benefits of taking part could include helping researchers understand if this new scanning method can identify early thigh bone fractures, which might lead to earlier diagnosis and treatment for others in the future. As DXA scans use low-level radiation, the risks involved are generally very small, similar to the radiation exposure you'd get from natural sources over a few days. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

University Health Network
Verified postcode
Toronto, Canada

Common questions

What is an Atypical Femur Fracture (AFF)?

It's a rare, specific type of crack or break in the main thigh bone (femur) that can sometimes be linked to certain medications.

What is a DXA scan?

A DXA scan is a special type of X-ray that measures how strong your bones are. It uses very low levels of radiation.

Why use a DXA scanner for this study?

Researchers want to see if the detailed imaging capabilities of a DXA scanner, which uses low radiation, can find these early thigh bone cracks.

What are bisphosphonates?

These are a type of medication commonly prescribed to help strengthen bones, often for people with osteoporosis.

Will I get paid to be in this study?

The information provided does not say whether participants will be compensated for taking part.