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Medication-related Osteonecrosis of the Jaw (MRONJ) Registry (MRONJ)

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ClinicalTrials.gov Identifier: NCT02932501
Recruitment Status : Recruiting
First Posted : October 13, 2016
Last Update Posted : January 18, 2019
Sponsor:
Collaborator:
AOCMF
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation

Brief Summary:
Approximately 500 patients will be included in this patient registry. Data collection includes demographics, clinical data of underlying disease and use of bisphosphonates, denosumab and antiangiogenic drugs , degree and extension of osteonecrosis, osteonecrosis-specific treatment, outcomes and complications within 1 year after treatment.

Condition or disease Intervention/treatment
Medication-related Osteonecrosis of the Jaw Bisphosphonate-Associated Osteonecrosis of the Jaw Procedure: Conservative treatment Procedure: Surgical treatment Procedure: Adjuvant non-surgical treatment

Detailed Description:
Approximately 500 patients diagnosed with medication-related osteonecrosis of the jaw will be enrolled in the study. Patients will undergo standard (routine) of care treatment, either conservative or surgical or both, and followed up during one year after the initiation of the treatment. Treatment outcome (development of the condition), pain and complications will be collected and documented over the duration of the registry.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: International, Multicenter, Prospective Registry to Collect Data of Treatment Patterns of Patients With Medication-related Osteonecrosis of the Jaw (MRONJ) and Their Outcome
Actual Study Start Date : August 14, 2017
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteonecrosis

Group/Cohort Intervention/treatment
MRONJ

Patients diagnosed of medication-related osteonecrosis of the jaw (MRONJ). Treatment strategies vary depending on the stage of MRONJ and can be of different nature as:

Conservative treatment Surgical treatment Adjuvant non-surgical treatment

Procedure: Conservative treatment
Disinfectant mouth rinses, Antibiotic therapy, Antifungal therapy

Procedure: Surgical treatment
Superficial debridement, Complete removal of necrotic bone, Complete bone resection, When applicable revision and soft tissue coverage

Procedure: Adjuvant non-surgical treatment
Hyperbaric oxygen therapy Pentoxifylline and tocopherol Ozone therapy Low level laser therapy Pain relief Anti-inflammatory treatment Platelet rich plasma Parathyroid hormone and teriparatide Bone morphogenetic protein




Primary Outcome Measures :
  1. Treatment outcome [ Time Frame: 6 months / 1 year ]

    Compared to the baseline status of the patient's condition, the outcome will be evaluated as:

    • Worsening of the osteonecrosis (e.g. size of the lesion increased)
    • No change of the osteonecrosis
    • Reduction of the osteonecrosis (e.g. size of the lesion decrease)
    • Complete mucosa healing


Secondary Outcome Measures :
  1. Pain perception [ Time Frame: 6 months / 1 year ]
    Numeric Rating Scale

  2. Staging of osteonecrosis [ Time Frame: 6 months / 1 year ]
    Staging of osteonecrosis according to the American Association of Oral and Maxillofacial Surgeons

  3. Site and size of the lesion [ Time Frame: 6 months / 1 year ]
    Site (single vs. multiple) and size of the lesion according to Weitzman et al.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients diagnosed of medication-related osteonecrosis of the jaw (MRONJ)
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Newly diagnosed patients with osteonecrosis in a facial bone other than the jaw, or
  • Newly diagnosed patients with non-exposed MRONJ (stage 0), or
  • Newly diagnosed patients with exposed MRONJ, i.e:

    • Current or previous treatment with antiresorptive or antiangiogenic agents.
    • Exposed bone or bone that can be probed through an intraoral or extraoral fistula(e) in the maxillofacial region that has persisted for more than 8 weeks
    • No history of radiation therapy to the jaws or obvious metastatic diseases of the jaw
  • Ability to understand the content of the patient information/ Informed Consent Form
  • Willingness and ability to participate in the clinical investigation according to the Registry Plan (RP)
  • Signed and dated IRB/EC-approved written informed consent
  • Mental capacity to comply with post-operative regimen, evaluation and data collection

Exclusion Criteria:

  • Recent history of substance abuse (i. e., recreational drugs, alcohol) that would preclude reliable assessment
  • Pregnancy or women planning to conceive within the registry period
  • Prisoner
  • Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present registry

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02932501


Contacts
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Contact: Víctor Díaz, PhD 0041814142507 victor.diaz@aofoundation.org

Locations
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United States, Kentucky
University of Kentucky Chandler Medical Center Not yet recruiting
Lexington, Kentucky, United States, 40536
Contact: Larry Cunningham         
United States, Texas
University of Texas Health Science Center Not yet recruiting
San Antonio, Texas, United States, 78229
Contact: Edward Ellis III         
Finland
Helsinki University Hospital Not yet recruiting
Helsinki, Finland, 00029
Contact: Risto Kontio, MD DDS PhD    +358 9 47188212    risto.kontio@medius.fi   
Principal Investigator: Risto Kontio, MD DDS PhD         
Germany
Charité - Universitätsmedizin Berlin Not yet recruiting
Berlin, Germany
Contact: Max Heiland         
Universitätskliniken Eppendorf Not yet recruiting
Hamburg, Germany
Contact: Alexandre Assaf         
Ludwig-Maximilians University Munich, Klinik und Poliklinik für Mund-, Kiefer und Gesichtschirurgie Recruiting
München, Germany, 80337
Contact: Sven Otto, PD. Dr. Dr.    +49 89 4400 54475    Sven.Otto@med.uni-muenchen.de   
Principal Investigator: Sven Otto, PD. Dr. Dr.         
Korea, Republic of
Kyungpool National University Not yet recruiting
Daegu, Korea, Republic of
Contact: Tae-Geon KWON         
Netherlands
Eramus MC Not yet recruiting
Rotterdam, Netherlands
Contact: Eppo Wolvius         
Qatar
Hamad Medical Corporation Not yet recruiting
Doha, Qatar
Contact: Moustafa Alkhalil, MD         
Romania
Emergency Clinical County Hospital of Constanta Recruiting
Constanta, Romania
Contact: Adrian Creanga, MD         
Slovenia
University Medical Centre Ljubljana Not yet recruiting
Ljubljana, Slovenia
Contact: Dime Sapundzhiev         
Spain
12 de Octubre University Hospital Recruiting
Madrid, Spain
Contact: Gregorio Sanchez Ancieto         
University Hospital La Paz de Madrid Not yet recruiting
Madrid, Spain
Contact: Miguel Burgueño         
Switzerland
Universitätsspital Basel Recruiting
Basel, Switzerland, 4031
Contact: Isabelle Berg, Dr.         
Luzerner Kantonsspital Recruiting
Luzern, Switzerland
Contact: Andrea Della Chiesa         
Universitätsspital Zürich Recruiting
Zürich, Switzerland
Contact: Paul Schumann         
Sponsors and Collaborators
AO Clinical Investigation and Documentation
AOCMF
Investigators
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Principal Investigator: Risto Kontio, MD DDS PhD Helsinki University Central Hospital

Additional Information:

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Responsible Party: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT02932501     History of Changes
Other Study ID Numbers: RP_MRONJ_1.0
First Posted: October 13, 2016    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by AO Clinical Investigation and Documentation:
Bisphosphonate
Jaw
Osteonecrosis
Antiresorptive drugs
Denosumab
Additional relevant MeSH terms:
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Osteonecrosis
Bisphosphonate-Associated Osteonecrosis of the Jaw
Bone Diseases
Musculoskeletal Diseases
Necrosis
Pathologic Processes
Jaw Diseases
Stomatognathic Diseases