AuthorisedTherapeutic exploratory (Phase II)Interventional

POMREP - Efficacy and safety of zoledronate versus placebo on pain at week 12 in pediatric patients with chronic recurrent multifocal osteomyelitis resistant to non-steroidal anti-inflammatory drug

This study, called POMREP, is for children who have a bone condition called Chronic Recurrent Multifocal Osteomyelitis (CRMO). This condition causes ongoing pain in their bones, and it hasn't improved with typical pain relief medicines. We are testing a medicine called zoledronate to see if it helps reduce this pain over 12 weeks. Some children will receive zoledronate, and others will receive a dummy medicine (placebo). We'll compare how much pain relief both groups experience, while also carefully checking for any side effects. The aim is to find out if zoledronate is a safe and effective treatment option for children with CRMO.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

Start

26 May 2026

Chronic recurrent multifocal osteomyelitis (CRMO)

What is this study about?

This study, called POMREP, is looking into a condition called Chronic Recurrent Multifocal Osteomyelitis (CRMO). This is a rare condition that mainly affects children and teenagers. It causes ongoing inflammation and pain in several bones at once, and it keeps coming back. For many children with CRMO, common pain relievers like ibuprofen or paracetamol don't fully help.

Because of this, doctors are exploring new ways to manage the pain and inflammation. This study focuses on a medicine called zoledronate. This drug is already used for other bone conditions in adults, but its effects on children with CRMO who haven't responded to other treatments aren't fully understood.

Our main goal is to find out if zoledronate can reduce pain in children with CRMO who haven't improved with regular pain medication. We also want to understand if it's a safe medicine for them to use. By comparing zoledronate to a dummy medicine, we hope to learn if it's a helpful new option for children living with this challenging condition.

Key takeaways

This study tests a new medicine (zoledronate) for children with CRMO.
It aims to see if zoledronate reduces pain and is safe.
Half of the children will get zoledronate, half will get a dummy medicine.
Participation involves regular visits and pain assessments using simple scales.
The study lasts about 9 months.

Who may be eligible?

To join this study, children need to have a diagnosis of Chronic Recurrent Multifocal Osteomyelitis (CRMO). This means they have ongoing bone inflammation and pain in multiple places, which has kept coming back.

Crucially, their pain must not have improved enough with standard pain-relieving medicines, such as non-steroidal anti-inflammatory drugs (NSAIDs).

If your child has CRMO and their pain is still a problem despite taking regular pain relief, they might be able to take part in this study.

Quick self-check

Does your child have Chronic Recurrent Multifocal Osteomyelitis (CRMO)?
Does your child still have pain from CRMO, even after taking regular pain relief like ibuprofen?
Is your child's age considered for participation in the study (there is no specific age limit mentioned, so it just needs to be confirmed with the study team)?
Are you able to attend regular hospital visits for check-ups over about 9 months?

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

What does participation involve?

If your child joins the study, they would be given either the study medicine (zoledronate) or a dummy medicine (placebo). Neither you nor your doctor would know which one your child is receiving.

They would have regular check-ups over about 9 months (36 weeks) to see how their pain is changing and to check for any side effects. This would involve filling out simple pain scales for children at these visits: at the start, and then at 4, 12, 24, and 36 weeks. We will also ask about how much other pain medication your child is taking and do physical exams to check their joints, spine, and skin. Blood tests will be done at the start and at 12, 24, and 36 weeks to look for signs of inflammation.

Potential risks and benefits

Taking part in any study involves careful consideration. Potential benefits might include your child receiving a treatment that could help reduce their pain. However, it's also possible your child might receive the dummy medicine or that the study medicine might not help them. As with all medicines, there could be side effects, and these would be carefully monitored throughout the study. You will be given more detailed information about possible risks. Remember, you can choose to withdraw your child from the study at any time, for any reason, without it affecting their ongoing medical care.

Locations (1)

—
France

Common questions

What is CRMO?

CRMO stands for Chronic Recurrent Multifocal Osteomyelitis. It's a rare condition where children get ongoing inflammation and pain in different bones, and it often comes back.

What is zoledronate?

Zoledronate is a medicine that affects bones. It's used for other bone problems and this study is trying to see if it can help children with CRMO pain.

What is a 'dummy medicine'?

A dummy medicine, or placebo, looks just like the study medicine but contains no active drug. This helps us fairly compare the effects of the active medicine.

How will you measure my child's pain?

Children will use simple scales, like a face chart or number scale, to describe how much pain they're feeling, depending on their age.

How long will the study last?

Your child would be in the study for about 9 months (36 weeks), with several check-up visits during that time.