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

March 19, 2024 updated by: AO Clinical Investigation and Publishing Documentation

International, Multicenter, Prospective Registry to Collect Data of Treatment Patterns of Patients With Medication-related Osteonecrosis of the Jaw (MRONJ) and Their Outcome

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / 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.

Study Type

Observational

Enrollment (Actual)

518

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Finland
      • Helsinki, Finland, 00029
        • Helsinki University Hospital
  • Germany
      • Berlin, Germany
        • Charite - Universitatsmedizin Berlin
      • Hamburg, Germany
        • Universitätskliniken Eppendorf
      • München, Germany, 80337
        • Ludwig-Maximilians University Munich, Klinik und Poliklinik für Mund-, Kiefer und Gesichtschirurgie
  • Korea, Republic of
      • Daegu, Korea, Republic of
        • Kyungpool National University
  • Netherlands
      • Rotterdam, Netherlands
        • Eramus MC
  • Qatar
      • Doha, Qatar
        • Hamad Medical Corporation
  • Romania
      • Constanta, Romania
        • Emergency Clinical County Hospital of Constanta
  • Slovenia
      • Ljubljana, Slovenia
        • University Medical Centre Ljubljana
  • Spain
      • Madrid, Spain
        • 12 de Octubre University Hospital
  • Switzerland
      • Basel, Switzerland, 4031
        • Universitatsspital Basel
      • Luzern, Switzerland
        • Luzerner Kantonsspital
      • Zürich, Switzerland
        • Universitätsspital Zürich
  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Chandler Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients diagnosed of medication-related osteonecrosis of the jaw (MRONJ)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months / 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain perception
Time Frame: 6 months / 1 year
Numeric Rating Scale
6 months / 1 year
Staging of osteonecrosis
Time Frame: 6 months / 1 year
Staging of osteonecrosis according to the American Association of Oral and Maxillofacial Surgeons
6 months / 1 year
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.
6 months / 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AO Clinical Investigation and Publishing Documentation

Collaborators

AOCMF

Investigators

  • Principal Investigator: Risto Kontio, MD DDS PhD, Helsinki University Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2017

Primary Completion (Actual)

October 13, 2023

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

October 12, 2016

First Submitted That Met QC Criteria

October 12, 2016

First Posted (Estimated)

October 13, 2016

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RP_MRONJ_1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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