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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
EU CTIS ID: 2023-506420-93-00
What this study is testing
To evaluate the efficacy of zoledronate, administered at increasing doses (0.025 mg/kg at baseline, 0.05 mg/kg at week 12, and 0.05 mg/kg at week 24; maximum dose 4 mg per infusion), versus placebo on the change in standardized pain score (0–10 scale) from baseline to week 12 in children aged ≥4 and <17 years with NSAID-resistant CRMO.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Children or teenagers (≥ 4 years and <17 years)
- 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.
You likely can't join if
- History of malignancy or current tumour
- 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) ;
- Contraindication to the study drug : Hypocalcemia
- Contraindication to the study drug : 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.
See the full eligibility criteria
- Children or teenagers (≥ 4 years and <17 years)
- 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.
- History of malignancy or current tumour
- 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) ;
- Contraindication to the study drug : Hypocalcemia
- Contraindication to the study drug : 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.
- ECG: check for congenital or acquired long QT > 0.44sec
- Pregnant or breastfeeding participants
- Serum 25-hydroxy vitamin D level <30 ng/mL at screening/baseline. These patients will not be randomized until correction of vitamin D deficiency and may be re-screened once vitamin D level is ≥30 ng/mL
- Clinically significant vertebral deformities, including vertebral fracture and/or angular kyphosis with risk of spinal cord compression
- Suspected tuberculosis.
- History of renal or hepatic insufficiency.
- Already enrolled in another interventional study.
- Not affiliated with the French social security system.
- Patient or legal guardians with limited understanding of the French language
- History of seizure
- Current infectious osteomyelitis
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.