Medication-related Osteonecrosis of the Jaw (MRONJ) Registry

Active, not recruiting

• Conditions: Medication-related Osteonecrosis of the Jaw; Bisphosphonate-Associated Osteonecrosis of the Jaw
• Interventions: Procedure: Conservative treatment; Procedure: Surgical treatment; Procedure: Adjuvant non-surgical treatment

• Registration Number: NCT02932501
• Lead Sponsor: AO Clinical Investigation and Publishing 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.

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 Timeline

• Study First Submitted: 2016-10-12
• Study First Submitted QC: 2016-10-12
• Study First Posted: 2016-10-13
• Study Start: 2017-08-14
• Primary Completion: 2023-10-13
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-20
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 518

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MRONJ	Conservative treatment	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
MRONJ	Adjuvant non-surgical treatment	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
MRONJ	Surgical treatment	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

Primary Outcome Measures

Name	Time	Method
Treatment outcome	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

Name	Time	Method
Pain perception	6 months / 1 year	Numeric Rating Scale
Staging of osteonecrosis	6 months / 1 year	Staging of osteonecrosis according to the American Association of Oral and Maxillofacial Surgeons
Site and size of the lesion	6 months / 1 year	Site (single vs. multiple) and size of the lesion according to Weitzman et al.

Trial Locations

Locations (14)

Universitätsspital Basel; 🇨🇭 Basel, Switzerland

University of Kentucky Chandler Medical Center; 🇺🇸 Lexington, Kentucky, United States

Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Universitätskliniken Eppendorf; 🇩🇪 Hamburg, Germany

Ludwig-Maximilians University Munich, Klinik und Poliklinik für Mund-, Kiefer und Gesichtschirurgie; 🇩🇪 München, Germany

Kyungpool National University; 🇰🇷 Daegu, Korea, Republic of

Eramus MC; 🇳🇱 Rotterdam, Netherlands

Hamad Medical Corporation; 🇶🇦 Doha, Qatar

Emergency Clinical County Hospital of Constanta; 🇷🇴 Constanta, Romania

University Medical Centre Ljubljana; 🇸🇮 Ljubljana, Slovenia

12 de Octubre University Hospital; 🇪🇸 Madrid, Spain

Universitätsspital Zürich; 🇨🇭 Zürich, Switzerland

Luzerner Kantonsspital; 🇨🇭 Luzern, Switzerland