RecruitingNAINTERVENTIONAL

RESTORE - Study of AGN1 LOEP to Prevent Secondary Hip Fractures

The RESTORE study is investigating a new treatment called AGN1 LOEP. Its main goal is to find out if this treatment can help prevent women from breaking their hip again after they've already had one hip fracture. The study focuses on women aged 65 to 91 who have recently had surgery for a hip fracture. Participants will be split into two groups: one receiving the AGN1 LOEP treatment on their unaffected hip, and another group receiving the usual care without the new treatment. Researchers will follow participants for at least five years to compare how many in each group experience another hip fracture. It's a large study, involving up to 2,400 women, to get clear answers about this potential new way to protect bone health.

At a glance

Status

Recruiting

Phase

Sponsor

AgNovos Healthcare, LLC

Enrolment target

2,400

Start

24 Apr 2021

Estimated completion

01 Apr 2029

Fragility Fracture Hip Fractures Osteoporosis

What is this study about?

When someone breaks their hip, it's a very serious event, and unfortunately, it can make them more likely to break the other hip too. This study, called RESTORE, is looking at a new procedure, AGN1 LOEP, which aims to make the uninjured hip stronger to help prevent this from happening.

Imagine you've had surgery for a broken hip. This study wants to see if adding the AGN1 LOEP treatment to your other, healthy hip could protect it from breaking in the future. The researchers need to compare a group of women who receive this new treatment with a group who receive the standard care, without the AGN1 LOEP treatment. This comparison helps them understand if the new treatment really makes a difference.

Researchers will follow participants for at least five years to carefully watch if more hip fractures occur. The aim is to find better ways to help older women stay active and healthy after a hip fracture, by reducing their chances of further breakages.

Key takeaways

This study investigates a new treatment to prevent a second hip fracture.
It's for women aged 65-91 who've recently had one hip fracture.
Participants will have regular follow-ups for at least 5 years.
The study aims to improve care for people at high risk of another broken hip.
You might receive the new treatment or standard care, decided by chance.

Who may be eligible?

This study is looking for women who are 65 to 91 years old and have already gone through menopause. You would have recently broken one hip due to a minor fall or accident and are having surgery to fix it. The study is specifically interested in women who might be at a higher risk of breaking their other hip in the future.

This higher risk could be due to several factors. For example, if you've fallen more than twice in the last year, have been told you're at risk of falls, or have weak bones (osteoporosis). Other factors include problems with your balance or eyesight, having previously broken a bone elsewhere, or taking many daily medications.

It's important that you are expected to be able to walk again after your hip surgery, even if you need some help, as the study involves follow-up appointments. You or your legal representative would also need to agree to take part and attend all scheduled appointments.

Quick self-check

Are you a woman aged between 65 and 91?
Have you gone through menopause?
Have you recently broken one hip due to a minor fall and are having surgery for it?
Are you expected to be able to walk again after your hip surgery?
Do you have other risk factors for falls or weak bones (e.g., previous falls, weak vision, previous bone breaks)?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join the RESTORE study, you would first have surgery to fix the hip you've already broken. Immediately after this, if you are in the treatment group, you would receive the AGN1 LOEP treatment on your other, uninjured hip. If you are in the control group, you would only receive the standard care for your broken hip, without the AGN1 LOEP treatment.

After your surgery, you would have regular check-ups. These visits will be at 6 weeks, then 6 months, and every 6 months after that. The researchers will follow you for at least 5 years to see how you are recovering and to check for any new hip fractures. The study involves keeping these appointments and allowing researchers to collect information about your health over this time.

Potential risks and benefits

Participating in a study like this could offer potential benefits, such as contributing to new knowledge that might help prevent future hip fractures in other women. If you receive the AGN1 LOEP treatment, there's a chance it could help strengthen your other hip and reduce your risk of another break, though this is what the study aims to find out. As with any medical procedure, there can be potential risks associated with the AGN1 LOEP treatment, and these would be fully explained to you before you agree to take part. You will also have regular medical follow-ups, which might give you more oversight of your health. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (66)

Innsbruck Hospital
Innsbruck, Austria· Recruiting
Ziekenhuis Oost-Limburg
Genk, Belgium· Recruiting
Ghent University Hospital
Ghent, Belgium· Recruiting
UZ Leuven
Leuven, Belgium· Recruiting
Vitaz Sint-Niklaas
Sint-Niklaas, Belgium· Recruiting
Health Sciences Centre - Eastern Health
St. John's, Canada· Withdrawn
QEII Health Sciences Centre
Halifax, Canada· Recruiting
Sunnybrook Health Sciences Centre
North York, Canada· Recruiting
Aarhus University Hospital
Aarhus, Denmark· Recruiting
CHU de Nice
Nice, France· Recruiting
CHU Amiens
Amiens, France· Recruiting
CHU Grenoble-Alpes
Grenoble, France· Recruiting

+54 more sites — see the official record for the full list.

Common questions

What is a 'secondary hip fracture'?

A secondary hip fracture means breaking your hip again, often the other hip, after you've already had one hip fracture.

What does 'osteoporosis' mean?

Osteoporosis is a condition where your bones become weak and brittle, making them more likely to break easily.

What is the AGN1 LOEP treatment?

AGN1 LOEP is a new procedure being tested to see if it can help strengthen your uninjured hip to prevent it from breaking in the future.

Will I know if I'm getting the new treatment?

While the study is designed so you won't know if you're getting the treatment or not, your care team will know. This helps ensure fair results.

How long will I be involved in the study?

You'll be followed for at least five years, with regular check-ups during that time.

How to find out more

Charles Raymond

restore@agnovos.com 240-753-6421 Official trial record

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