Medication-related Osteonecrosis of the Jaw (MRONJ) Registry

NCT02932501 | Active Not Recruiting

• 1 other identifier: RP_MRONJ_1.0
• Study Type: observational
• Target: 518
• Locations: 10 countries
• Sites: 14

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.

Conditions

Medication-related Osteonecrosis of the Jaw; Bisphosphonate-Associated Osteonecrosis of the Jaw

Keywords

Bisphosphonate; Jaw; Osteonecrosis; Antiresorptive drugs; Denosumab

Outcome Measures

Primary Outcomes (1)

• Treatment outcome

  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 Outcomes (3)

• Pain perception

  6 months / 1 year

• Staging of osteonecrosis

  6 months / 1 year

• Site and size of the lesion

  6 months / 1 year

Study Arms (1)

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; Procedure: Surgical treatment; Procedure: Adjuvant non-surgical treatment

Interventions

Conservative treatment PROCEDURE

Disinfectant mouth rinses, Antibiotic therapy, Antifungal therapy

MRONJ

Surgical treatment PROCEDURE

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

MRONJ

Adjuvant non-surgical treatment PROCEDURE

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

MRONJ

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AO Clinical Investigation and Publishing Documentation: lead
• AOCMF: collaborator

Study Sites (14)

University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536, United States

Location

Helsinki University Hospital

Helsinki, 00029, Finland

Location

Charité - Universitätsmedizin Berlin

Berlin, Germany

Location

Universitätskliniken Eppendorf

Hamburg, Germany

Location

Ludwig-Maximilians University Munich, Klinik und Poliklinik für Mund-, Kiefer und Gesichtschirurgie

München, 80337, Germany

Location

Eramus MC

Rotterdam, Netherlands

Location

Hamad Medical Corporation

Doha, Qatar

Location

Emergency Clinical County Hospital of Constanta

Constanța, Romania

Location

University Medical Centre Ljubljana

Ljubljana, Slovenia

Location

Kyungpool National University

Daegu, South Korea

Location

12 de Octubre University Hospital

Madrid, Spain

Location

Universitätsspital Basel

Basel, 4031, Switzerland

Location

Luzerner Kantonsspital

Lucerne, Switzerland

Location

Universitätsspital Zürich

Zurich, Switzerland

Location

MeSH Terms

Conditions

Bisphosphonate-Associated Osteonecrosis of the Jaw; Osteonecrosis

Interventions

Conservative Treatment; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Jaw Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Risto Kontio, MD DDS PhD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2016
• First Posted: October 13, 2016
• Study Start: August 14, 2017
• Primary Completion: October 13, 2023
• Study Completion: April 1, 2024
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1); US (1); RO (1); KR (1); SL (1); NL (1); CH (3); DE (3); QA (1); ES (1)