Medication-related Osteonecrosis of the Jaw (MRONJ) Registry

Bisphosphonate-Associated Osteonecrosis of the Jaw Clinical Trial

— MRONJ  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02932501
• Other study ID #: RP_MRONJ_1.0
• Status: Active, not recruiting
• Start date: August 14, 2017
• Est. completion date: April 2024

Study information

• Verified date: March 2024
• Source: AO Innovation Translation Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 518
• Est. completion date: April 2024
• Est. primary completion date: October 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Conservative treatment
Disinfectant mouth rinses, Antibiotic therapy, Antifungal therapy
• Surgical treatment
Superficial debridement, Complete removal of necrotic bone, Complete bone resection, When applicable revision and soft tissue coverage
• 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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
AO Clinical Investigation and Publishing Documentation	AOCMF

Countries where clinical trial is conducted

United States,  Finland,  Germany,  Korea, Republic of,  Netherlands,  Qatar,  Romania,  Slovenia,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain perception	Numeric Rating Scale	6 months / 1 year
Secondary	Staging of osteonecrosis	Staging of osteonecrosis according to the American Association of Oral and Maxillofacial Surgeons	6 months / 1 year
Secondary	Site and size of the lesion	Site (single vs. multiple) and size of the lesion according to Weitzman et al.	6 months / 1 year