Could a bone drug ease pain in kids with rare inflammatory disease?
NCT ID NCT07668583
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether the drug zoledronate can reduce pain in children aged 4 to 17 with chronic recurrent multifocal osteomyelitis (CRMO), a rare auto-inflammatory bone disease. The 30 participants have not responded to standard anti-inflammatory drugs. They will receive either zoledronate or a placebo by IV, and their pain levels will be tracked over 12 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- zoledronate (a bisphosphonate drug given by IV)
- What this could lead to
- If it works, this could point toward a new treatment option for children with hard-to-treat CRMO bone pain.
- What could go wrong
- This is a small early-phase trial with only 30 children, so results may not apply to everyone. The drug also has known risks like flu-like symptoms and kidney issues.
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.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Sep 2026
An estimate. Start dates often move.
- Expected to finish
-
Dec 2029
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.
- Ages
-
4 to 17 years
- 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 Hide 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: * aged ≥4 and \<17 years for whom: * Physician-confirmed diagnosis of CRMO according to Jansson's criteria, with compatible MRI findings. Having lesions on MRI within 12 weeks prior to inclusion and clinically active disease defined by at least one of 2 criteria: patient/parent VAS (pain) superior or equal to 30/100 and/or physician VAS superior or equal to 30/100 after failure of at least 4 weeks of NSAIDs at a stable dose * Written informed consent signed by the parents (the child may sign the consent if they wish, but their signature is not mandatory) * Having had a dental review within 3 months prior to inclusion, with completion of any necessary invasive dental work before the first dose of zoledronate. Exclusion Criteria: * History of malignancy or current tumour * History of seizure * Current infectious osteomyelitis * Contraindication to the study drug * Hypersensitivity to the active substance, to other bisphosphonates, or to any excipient (sodium hydroxide, hydrochloric acid for pH adjustment, water for injection) ; * Hypocalcemia ; * Severe renal impairment with creatinine clearance \< 35 ml/min ; * Prior treatment with bisphosphonates and/or biotherapy within 6 months prior to inclusion. * History of HIV, HBV, or HCV infection. * Congenital or acquired prolonged QT interval (\>0.44 seconds) on ECG. * Clinically significant vertebral deformities, including vertebral fracture and/or angular kyphosis with risk of spinal cord compression. * Suspected or confirmed tuberculosis. * History of renal or hepatic insufficiency. * Already enrolled in another interventional study. * Pregnant or breastfeeding participants * Not affiliated with the French social security system. * Patient or legal guardians with limited understanding of the French language * Serum 25-hydroxy vitamin D level \<30 ng/mL at screening. Participants may be re-screened after correction of vitamin D deficiency.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Chronic recurrent multifocal osteomyelitis are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
Kremlin-Bicêtre Hospital
Le Kremlin-Bicêtre, Val De Marne, 94270, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.