Medication-related Osteonecrosis of the Jaw (MRONJ) Registry
Study Details
Study Description
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 | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age > 18 years
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Newly diagnosed patients with osteonecrosis in a facial bone other than the jaw, or
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Newly diagnosed patients with non-exposed MRONJ (stage 0), or
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Newly diagnosed patients with exposed MRONJ, i.e:
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Current or previous treatment with antiresorptive or antiangiogenic agents.
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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
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No history of radiation therapy to the jaws or obvious metastatic diseases of the jaw
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Ability to understand the content of the patient information/ Informed Consent Form
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Willingness and ability to participate in the clinical investigation according to the Registry Plan (RP)
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Signed and dated IRB/EC-approved written informed consent
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Mental capacity to comply with post-operative regimen, evaluation and data collection
Exclusion Criteria:
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Recent history of substance abuse (i. e., recreational drugs, alcohol) that would preclude reliable assessment
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Pregnancy or women planning to conceive within the registry period
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Prisoner
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Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present registry
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Kentucky Chandler Medical Center | Lexington | Kentucky | United States | 40536 |
| 2 | University of Texas Health Science Center | San Antonio | Texas | United States | 78229 |
| 3 | Helsinki University Hospital | Helsinki | Finland | 00029 | |
| 4 | Charité - Universitätsmedizin Berlin | Berlin | Germany | ||
| 5 | Universitätskliniken Eppendorf | Hamburg | Germany | ||
| 6 | Ludwig-Maximilians University Munich, Klinik und Poliklinik für Mund-, Kiefer und Gesichtschirurgie | München | Germany | 80337 | |
| 7 | Kyungpool National University | Daegu | Korea, Republic of | ||
| 8 | Eramus MC | Rotterdam | Netherlands | ||
| 9 | Eramus MC | Rotterdam | Netherlands | ||
| 10 | Hamad Medical Corporation | Doha | Qatar | ||
| 11 | Emergency Clinical County Hospital of Constanta | Constanta | Romania | ||
| 12 | University Medical Centre Ljubljana | Ljubljana | Slovenia | ||
| 13 | 12 de Octubre University Hospital | Madrid | Spain | ||
| 14 | University Hospital La Paz de Madrid | Madrid | Spain | ||
| 15 | Universitätsspital Basel | Basel | Switzerland | 4031 | |
| 16 | Luzerner Kantonsspital | Luzern | Switzerland | ||
| 17 | Universitätsspital Zürich | Zürich | Switzerland |
Sponsors and Collaborators
- AO Clinical Investigation and Publishing Documentation
- AOCMF
Investigators
- Principal Investigator: Risto Kontio, MD DDS PhD, Helsinki University Central Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RP_MRONJ_1.0