ClinicalTrials.gov record NCT04725422

CHronic Nonbacterial Osteomyelitis International Registry

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Aug 22, 2026

CHronic Nonbacterial Osteomyelitis International Registry (CHOIR)

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.The registry record was last updated on Jul 30, 2024, about 2 years ago, so the status shown may be out of date. The study team or the registry can confirm.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
AgeUp to 21 years old
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is an international prospective registry for people age 21 years and younger with CNO/CRMO. It collects clinical information, imaging (MRI), and treatment data over time to track disease course and how patients respond to different management approaches. The registry aims to provide long-term outcome and safety data.

What it is studying. The registry is collecting prospective clinical, imaging, and treatment information to describe the natural history of CNO/CRMO, monitor responses to different clinical managements, and characterize long-term outcomes and safety.

What the researchers hope to learn. To investigate the natural history of CNO/CRMO; to study how patients respond to different clinical managements (including consensus treatment plans); to validate reported risk factors for severe disease; and to characterize long-term outcomes and safety.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

The objective of the study is to establish a prospective disease registry for chronic recurrent multifocal osteomyelitis (CRMO)/chronic nonbacterial osteomyelitis (CNO) in order to investigate the natural history of the disease and the responses of patients to different clinical managements over 10 years.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • Methotrexate
  • Sulfasalazine
  • Leflunomide
  • Pamidronate
  • Zoledronic acid
  • Etanercept
  • Adalimumab
  • Certolizumab
  • Infliximab
  • Golimumab
  • NSAID

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Age at enrollment is equal to or younger than 21 years of age
  • Presence of bone edema on STIR or T2 fat saturation sequence on MRI within 12 weeks of enrollment
  • Whole body imaging evaluation (either WB MRI or bone scintigraphy)
  • Bone biopsy to exclude infection or malignancy unless bone lesions follow typical distribution or there is IBD, psoriasis, or palmar plantar pustulosis

Exclusion criteria

  • History of or current malignancy
  • Current infectious osteomyelitis
  • Contraindication to the selected treatment agent

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

Chronic nonbacterial osteomyelitis (CNO) is an autoinflammatory bone disease that mainly affects children and adolescents. Clinical presentations range from mild and sometimes limited unifocal disease to severe, chronically active or recurrent inflammation of multiple bones. The latter is referred to as chronic recurrent multifocal osteomyelitis (CRMO). Here we will use the term "CNO" to refer to the entire spectrum of this disease. CNO can be complicated by vertebral compression fractures, kyphosis, and leg length discrepancy when it is not recognized early or treated adequately. The diagnosis of CNO is made by excluding alternatives in the differential diagnosis including malignancy (leukemia, lymphoma, and primary or metastatic bone tumors), Langerhans cell histiocytosis, and infection. Clinical assessment in conjunction with serum inflammatory parameters and imaging studies, particularly magnetic resonance imaging (MRI), are crucial for the diagnosis and monitoring of disease activity of CNO1. Because of significant variation in clinical treatment practices among pediatric rheumatologists, standardized treatment regimens (consensus treatment plans, CTPs) have been developed within the Childhood Arthritis and Rheumatology Research Alliance (CARRA), a North American organization comprised of pediatric rheumatologists and researchers, for CNO patients with an NSAID-refractory course and/or with active spinal lesions2. These CTPs provide an opportunity for pediatric rheumatologists to conduct comparative effectiveness research on CNO through prospective data collection. CRMO/CNO workgroup is comprised of pediatric rheumatologists from North America as well as international colleagues who are interested in collaborating in CNO research. Furthermore, risk factors of severe disease have been described by Wipff et al. based on a large retrospective cohort study3. Their results may be validated by an independent prospective cohort study. To date, there has been only one prospective study on CNO since its first description in 19724. Therefore, we propose to establish this international registry of patients with CNO to accomplish above goals. Long-term outcomes of CNO remains unknown due to the lack of prospective study. It has been estimated that at least 50% of CNO patients continue to need medications for CNO during adulthood. Our study will collect the clinical data and provide valuable data to characterize the long-term outcomes.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants join a prospective registry with long-term follow-up (the registry describes data collection over 10 years). They will have clinical assessments used to calculate a disease activity score (patient and physician global assessments and lesion counts). Procedures may include MRI (STIR or T2 fat-saturation), whole-body imaging (WB MRI or bone scan), and, when needed to rule out infection or cancer, a bone biopsy. The study records treatments given and monitors safety, including reporting serious adverse events.

How the study is structured. A prospective observational registry (cohort). Participants continue usual care chosen by their clinicians; the study records clinical visits, MRI or whole-body imaging, treatments used, and safety events. Data are collected over time with follow-up planned for 10 years.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on chronic recurrent multifocal osteomyelitis

Clinical trials4 trials listed for chronic recurrent multifocal osteomyelitisEvery trial the registry lists for chronic recurrent multifocal osteomyelitis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in chronic recurrent multifocal osteomyelitis researchLatest monthly update: September 2026. Includes: Stronger medicines. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Aug 1, 2018
Primary completion
August 2028 (estimated)
Study completion
August 2050 (estimated)
Target enrollment
2000 participants (estimated)
Last updated on registry
Jul 30, 2024
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Seattle Children's Hospital
Principal investigator
Yongdong (Dan) Zhao, Principle Investigator
Seattle Children's Hospital
Collaborators
  • Boston Children's Hospital, Boston, MA, USA
  • Hospital for Special Surgery, New York
  • Joseph M Sanzari Children's Hospital, Hackensack University Medical Center, Hackensack, NJ, USA
  • Riley Children's Hospital, Indianapolis, IN, USA
  • University of North Carolina, Chapel Hill, NC, USA
  • Royal Children's Hospital
  • Hacettepe University
  • Bambino Gesù Children's Hospital, Rome, Italy
  • University of British Columbia, Vancouver, BC, Canada
  • Meyer Children's Hospital, Florence, Italy
  • Mansoura University
  • University of Utah, Salt Lake City, UT, USA
  • University of Iowa Carver College of Medicine, Iowa City, IA, USA
  • Ann & Robert H Lurie Children's Hospital of Chicago
  • Palacky University Olomouc Institute of Molecular and Translational Medicine, Olomouc, Czechia
  • Alder Hey Children's NHS Foundation Trust
  • University of Calgary

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

disease registry
An organised collection of information about people with a particular condition, gathered over time for research. Joining a registry usually means sharing medical information, not receiving a treatment.
natural history
A study that follows how a condition changes over time without assigning an experimental treatment. It may involve study visits and tests, and is often used to plan future trials.
enrollment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
MRI
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
biopsy
Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
Contraindication
A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
refractory
A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
retrospective cohort
A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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