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Zoledronic acid versus placebo for pain relief in children with chronic recurrent multifocal osteomyelitis resistant to NSAIDs

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on Chronic recurrent multifocal osteomyelitis, a rare condition that causes recurring inflammation and pain in several bones. The investigational medication is zoledronic acid, a drug given through an IV infusion that is intended to reduce bone pain and inflammation. Children who do not get relief from standard anti‑inflammatory medicines may receive either the active drug or an inactive substance (placebo) for comparison.

The purpose of the study is to determine whether the drug improves pain levels after 12 weeks compared with placebo. Participants receive an infusion at the start of the study, then again at about 12 weeks and 24 weeks, with follow‑up visits extending to 36 weeks. At each visit, pain is recorded using simple age‑appropriate scales that involve faces or a line marked from “no pain” to “worst pain.” Whole‑body imaging with MRI (a scan that creates detailed pictures of the bones) is performed to see how many bone lesions are present. Safety checks include monitoring for flu‑like symptoms, headache, and low levels of phosphate or calcium in the blood.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline visit and initial assessments

    After joining the study, you attend the baseline visit where the research team records your age, weight and height, and explains the study procedures.

    Your pain level is measured using an age‑appropriate scale, and a physical examination is performed to note any joint pain or other symptoms.

    Blood samples are taken to check white blood cell count, platelet count, c‑reactive protein and other inflammation markers.

    A whole‑body mri scan is done to document bone lesions.

    You complete a quality‑of‑life questionnaire and receive a diary to record any use of pain medication such as nsaids.

    The first infusion is given. depending on random assignment, you receive either zoledronate at a dose of 0.025 mg per kilogram of body weight (not exceeding 4 mg) or a matching placebo.

  2. Step 2

    Post‑infusion monitoring

    After the infusion you are observed for a short period to watch for flu‑like symptoms, headache, or changes in calcium levels.

    Any immediate reactions are recorded in your study file.

  3. Step 3

    Week 4 follow‑up visit

    You return for a visit four weeks after the baseline infusion.

    Pain assessment is repeated using the same scale.

    The diary is reviewed to note how many days nsaids or other pain medicines were taken.

    No additional infusion is given at this time.

  4. Step 4

    Week 12 assessment and second infusion

    At twelve weeks you undergo another pain assessment, physical exam, blood tests and a repeat mri scan.

    Quality‑of‑life questionnaire and diary information are collected again.

    A second infusion is administered. the dose of zoledronate (or placebo) is 0.05 mg per kilogram of body weight, again not exceeding 4 mg.

  5. Step 5

    Post‑infusion monitoring after week 12

    You are observed for possible side effects in the same way as after the baseline infusion.

  6. Step 6

    Week 24 assessment and third infusion

    At twenty‑four weeks you repeat pain scoring, physical examination, blood analyses and mri imaging.

    The diary is checked for medication use, and the quality‑of‑life questionnaire is completed.

    The third infusion is given with the same dose as the week‑12 infusion: 0.05 mg per kilogram (maximum 4 mg).

  7. Step 7

    Post‑infusion monitoring after week 24

    Observation for side effects is performed as previously.

  8. Step 8

    Week 36 final visit

    The last study visit occurs at thirty‑six weeks.

    Pain level, physical signs, blood tests and mri are evaluated one final time.

    Final quality‑of‑life questionnaire and diary data are collected.

    No further infusions are given after this visit.

Who can join the trial?

5 criteria

  • Be a child or teenager who is at least 4 years old but younger than 17 years.
  • Have a doctor‑confirmed diagnosis of Chronic recurrent multifocal osteomyelitis (CRMO) that meets Jansson’s criteria and shows matching findings on a recent MRI (magnetic resonance imaging) scan performed within the past 12 weeks.
  • Show active disease, meaning you must have either a pain rating of 30 or higher out of 100 on a VAS (visual analog scale) filled out by you or your parent, or a rating of 30 or higher filled out by your doctor, after at least 4 weeks of taking stable doses of NSAIDs (non‑steroidal anti‑inflammatory drugs, such as ibuprofen) without enough relief.
  • Provide a signed informed consent from a parent or legal guardian (the child can also sign, but it is not required).
  • Have had a dental check‑up within the last 3 months, and any needed invasive dental work (procedures that go into the tooth or gums, like extractions or deep cleanings) must be completed before receiving the first dose of the study drug zoledronate.

Who cannot join the trial?

17 criteria

  • Having had cancer or currently having a tumor.
  • Being allergic (hypersensitivity) to the study drug, to other bisphosphonates, or to ingredients such as sodium hydroxide, hydrochloric acid, or sterile water.
  • Having low blood calcium, known as hypocalcemia.
  • Having severe kidney problems with a creatinine clearance less than 35 ml/min (a test that measures how well the kidneys work).
  • Having taken any bisphosphonate medicines or special immune‑targeting therapies (biotherapy) within the past 6 months.
  • Having a history of HIV, hepatitis B (HBV), or hepatitis C (HCV) infection.
  • Having an ECG (heart test) that shows a prolonged long QT interval greater than 0.44 seconds, which can affect heart rhythm.
  • Being pregnant or breastfeeding.
  • Having a blood level of vitamin D (serum 25‑hydroxy vitamin D) lower than 30 ng/mL at the screening visit.
  • Having serious spine problems such as a vertebral fracture or a sharp forward curve of the spine (kyphosis) that could lead to spinal cord compression.
  • Being suspected of having tuberculosis, a bacterial infection that usually affects the lungs.
  • Having a history of kidney (renal insufficiency) or liver (hepatic insufficiency) failure.
  • Already taking part in another clinical trial (interventional study).
  • Not being covered by the French social security system.
  • Patient or legal guardian having limited ability to understand the French language.
  • Having a history of seizure disorders.
  • Having a current bone infection (infectious osteomyelitis).
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Investigated drugs

Zoledronic acid is a medication given as an IV infusion that belongs to a group of drugs called bisphosphonates. In this study it is being tested to see if it can reduce the amount of bone pain that children with chronic recurrent multifocal osteomyelitis (CRMO) feel. The drug works by slowing down the activity of cells that break down bone, which can help stabilize the bone and lessen inflammation and pain. Participants receive the medication at several time points during the trial, and researchers will compare their pain scores to see if the drug provides relief.

What is already known about the treatment

  • ZOLEDRONIC ACID

    This medication is given as a sterile solution that is injected into a vein (intravenous infusion). It is an approved drug that is already used for several bone disorders and has a large amount of research behind it. In this study it is being tested to reduce pain in children with chronic recurrent multifocal osteomyelitis, a rare bone inflammation. It works by attaching to bone and slowing down the cells that break down bone, and it belongs to the bisphosphonate class of medicines.

  • PLACEBO OF ZOLEDRONIC ACID

    The placebo is a matching infusion solution that contains no active drug and is given by the same intravenous method. It is used only as a control in clinical trials and has no therapeutic effect on any disease. It does not have a medical indication and its purpose is to help researchers compare the effects of the real medication. It is simply an inert substance used for comparison in the study.

Investigated diseases

Chronic recurrent multifocal osteomyelitis (CRMO) - Chronic recurrent multifocal osteomyelitis is a rare, non‑infectious inflammation of bone that typically starts in childhood. It causes recurring episodes of bone pain, swelling, and tenderness that can affect many different bones at once or at different times. New painful sites may appear while older lesions heal, leading to a pattern of flare‑ups and partial remission. Over time the inflammation can cause thickening or softening of the affected bone. Some children also develop skin changes such as acne or psoriasis, and a few may have gut inflammation. The disease course varies, with periods of activity alternating with quieter phases.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IITrial ID2023-506420-93-00Estimated enrolment30 patientsSponsorAssistance Publique Hopitaux De Paris

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