Various Treatments for Chronic Multifocal Osteomyelitis
(CHOIR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to learn more about chronic nonbacterial osteomyelitis (CNO), a condition that causes painful bone swelling. Researchers plan to track the disease's progression and evaluate how different treatments help over the next 10 years. Participants may receive one of several treatments, including medications like methotrexate or infliximab (a TNF inhibitor), to determine which is most effective. The trial seeks participants 21 years or younger who have shown bone swelling in recent MRI scans.
As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the treatments under study have different safety levels based on past findings.
For bisphosphonates like zoledronic acid and pamidronate, studies have found they are generally well-tolerated. Common side effects include bone pain, nausea, and tiredness, but most people can manage these.
Disease-modifying anti-rheumatic drugs (DMARDs) like methotrexate, sulfasalazine, and leflunomide are considered relatively safe. However, methotrexate and leflunomide can affect the liver, so liver tests are often recommended during treatment.
Tumor necrosis factor inhibitors (TNFi) such as adalimumab, etanercept, infliximab, and golimumab are widely used for various conditions. They are generally safe, though they may increase the risk of infections. Specifically, adalimumab has a strong safety record for long-term use based on studies across multiple diseases.
Overall, these treatments are well-researched and have established safety profiles for their approved uses. However, individual experiences may vary, and discussing any concerns with a healthcare provider is important.12345Why are researchers excited about this trial?
Researchers are excited about the treatments being explored for Chronic Nonbacterial Osteomyelitis because they offer diverse approaches to managing this complex condition. Unlike standard options that often rely on non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids, these investigational treatments include tumor necrosis factor inhibitors (TNFi) like Adalimumab, Certolizumab, Etanercept, Golimumab, and Infliximab, which target specific inflammatory pathways, potentially reducing inflammation more effectively. Additionally, bisphosphonates such as Pamidronate and Zoledronic acid can strengthen bones and manage bone pain, providing a novel approach for patients who struggle with bone-related symptoms. By exploring these varied mechanisms and delivery methods, researchers hope to find more personalized and effective treatment options for those affected by this condition.
What evidence suggests that this trial's treatments could be effective for CRMO/CNO?
Research shows several treatment options for conditions like chronic recurrent multifocal osteomyelitis (CRMO) and chronic nonbacterial osteomyelitis (CNO). In this trial, participants may receive tumor necrosis factor inhibitors (TNF inhibitors) such as adalimumab, etanercept, infliximab, and golimumab. These inhibitors have effectively reduced inflammation in diseases similar to CRMO/CNO by blocking a protein that causes inflammation. Other participants may receive bisphosphonates, like pamidronate and zoledronic acid, which studies have found can help strengthen bones and reduce pain and fractures. Additionally, some participants may receive disease-modifying antirheumatic drugs (DMARDs), including methotrexate and sulfasalazine, which have effectively reduced symptoms and improved joint function in inflammatory conditions. While these treatments show promise, their effectiveness can vary from person to person.678910
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive various treatments including bisphosphonates, NSAIDs, DMARDs, and TNF inhibitors based on standardized treatment regimens
Follow-up
Participants are monitored for safety and effectiveness after treatment, including disease activity score and MRI lesion count
Long-term monitoring
Collection of clinical data to characterize long-term outcomes of CNO
What Are the Treatments Tested in This Trial?
Interventions
- Adalimumab
- Certolizumab
- Etanercept
- Golimumab
- Infliximab
- Leflunomide
- Methotrexate
- Pamidronate
- Sulfasalazine
- Zoledronic acid
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
1. Adalimumab (subcutaneous) 10-40 mg SQ every other week 2. Etanercept (subcutaneous) 12.5-50 mg SQ every week 3. Infliximab (intravenous) 10 mg/kg (max 1000 mg) i.v. at week 0,2, 6 then every 4 weeks 4. Golimumab (subcutaneous or intravenous) 2 mg/kg (max 200 mg) at every 4 weeks
1. Naproxen 10 mg/kg (max 500 mg) PO twice daily 2. Indomethacin 1 mg/kg (max daily dose 150 mg) PO twice or three times daily 3. Meloxicam 0.1-0.3 mg/kg (max 15 mg) PO daily 4. Piroxicam 10-20 mg PO daily 5. Ibuprofen 10 mg/kg (max 800 mg) PO 3-4 times daily
1. Methotrexate 1 mg/kg (max 25 mg) PO or SQ weekly 2. Sulfasalazine 30 mg/kg (max 1000 mg) PO twice daily 3. Leflunomide 10-20 mg PO daily
1. Pamidronate 1 mg/kg (max 90 mg) (intravenous)\*: Option 1: every month Option 2: 3 consecutive days every 3 months 2. Zoledronic acid 0.0125-0.05 mg/kg (max 4mg) (intravenous): every 3-6 months. \* Both options may use lower dose of 0.5 mg/kg at the initiation of the treatment. All options allow concurrent use of NSAIDs.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Seattle Children's Hospital
Lead Sponsor
Boston Children's Hospital, Boston, MA, USA
Collaborator
Hospital for Special Surgery, New York
Collaborator
University of Utah, Salt Lake City, UT, USA
Collaborator
University of Iowa Carver College of Medicine, Iowa City, IA, USA
Collaborator
Ann & Robert Lurie Children's Hospital of Chicago, Chicago, IL, USA
Collaborator
Palacky University Olomouc Institute of Molecular and Translational Medicine, Olomouc, Czechia
Collaborator
Alder Hey Children's NHS Foundation Trust Hospital, Liverpool, UK
Collaborator
University of Calgary, Calgary, Alberta, Canada
Collaborator
Royal Children's Hospital
Collaborator
Citations
Comparative Effectiveness on Survival of Zoledronic Acid ...
Zoledronic acid is associated with increased overall survival and decreased skeletal related events compared to pamidronate in patients with multiple myeloma.
2.
journals.lww.com
journals.lww.com/md-journal/fulltext/2015/10030/efficacy_and_safety_of_zoledronic_acid_and.69.aspxEfficacy and Safety of Zoledronic Acid and Pamidronate...
This meta-analysis indicates that treatment with zoledronic acid was more effective than pamidronate disodium in the complete response assessments.
Efficacy and safety of zoledronic acid in the treatment ...
Zoledronic acid can significantly improve BMD of the lumbar spine, femoral neck and trochanter, and effectively reduce incidence of fracture in patients with ...
Once-Yearly Zoledronic Acid for Treatment ...
A single infusion of intravenous zoledronic acid decreases bone turnover and improves bone density at 12 months in postmenopausal women with osteoporosis.
5.
aacrjournals.org
aacrjournals.org/clincancerres/article/19/24/6863/14519/Comparative-Efficacy-of-Bisphosphonates-inComparative Efficacy of Bisphosphonates in Metastatic Breast ...
In prostate cancer, the SRE rates were 0.83 for zoledronic acid, 1.11 for clodronate (35%), and 1.41 for pamidronate (71%). In multiple myeloma, the SRE rates ...
Safety Data Sheet
Precautions for safe handling. No special precautions are necessary if used correctly. Avoid breathing dust/fume/gas/mist/vapours/spray. Avoid ...
7.
imgcdn.mckesson.com
imgcdn.mckesson.com/CumulusWeb/Click_and_learn/SDS_SAGENT_ZOLEDRONIC_ACID_PGBCK_4MG_100ML_100ML.pdfZoledronic Acid Injection Safety Data Sheet (SDS) (a) ...
During all fire fighting activities, wear appropriate protective equipment, including self-contained breathing apparatus. Section 6 - Accidental ...
Long-term efficacy and safety of zoledronic acid compared ...
Zoledronic acid (4 mg) and pamidronate were tolerated equally well. The most common adverse events included bone pain, nausea, and fatigue. Conclusions: Long- ...
9.
cdn.pfizer.com
cdn.pfizer.com/pfizercom/products/material_safety_data/Pamidronate_disodium(Hospira)_30-march-2017.pdfSAFETY DATA SHEET
Carcinogen Status: Not listed as a carcinogen by IARC, NTP or US OSHA. Material Name: Pamidronate Disodium Injection (Hospira, Inc.)
SAFETY DATA SHEET
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
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