Medication-related Osteonecrosis of the Jaw (MRONJ) Registry (MRONJ)
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| ClinicalTrials.gov Identifier: NCT02932501 |
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Recruitment Status :
Recruiting
First Posted : October 13, 2016
Last Update Posted : January 18, 2019
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Sponsor:
AO Clinical Investigation and Documentation
Collaborator:
AOCMF
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
|---|---|
| Medication-related Osteonecrosis of the Jaw Bisphosphonate-Associated Osteonecrosis of the Jaw | Procedure: Conservative treatment Procedure: Surgical treatment Procedure: Adjuvant non-surgical treatment |
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 [Patient Registry] |
| Estimated Enrollment : | 500 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 1 Year |
| 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 |
| Actual Study Start Date : | August 14, 2017 |
| Estimated Primary Completion Date : | June 2021 |
| Estimated Study Completion Date : | September 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Osteonecrosis
| Group/Cohort | Intervention/treatment |
|---|---|
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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 |
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- Pain perception [ Time Frame: 6 months / 1 year ]Numeric Rating Scale
- Staging of osteonecrosis [ Time Frame: 6 months / 1 year ]Staging of osteonecrosis according to the American Association of Oral and Maxillofacial Surgeons
- 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.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients diagnosed of medication-related osteonecrosis of the jaw (MRONJ)
Criteria
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
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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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02932501
Contacts
| Contact: Víctor Díaz, PhD | 0041814142507 | victor.diaz@aofoundation.org |
Locations
| United States, Kentucky | |
| University of Kentucky Chandler Medical Center | Not yet recruiting |
| Lexington, Kentucky, United States, 40536 | |
| Contact: Larry Cunningham | |
| United States, Texas | |
| University of Texas Health Science Center | Not yet recruiting |
| San Antonio, Texas, United States, 78229 | |
| Contact: Edward Ellis III | |
| Finland | |
| Helsinki University Hospital | Not yet recruiting |
| Helsinki, Finland, 00029 | |
| Contact: Risto Kontio, MD DDS PhD +358 9 47188212 risto.kontio@medius.fi | |
| Principal Investigator: Risto Kontio, MD DDS PhD | |
| Germany | |
| Charité - Universitätsmedizin Berlin | Not yet recruiting |
| Berlin, Germany | |
| Contact: Max Heiland | |
| Universitätskliniken Eppendorf | Not yet recruiting |
| Hamburg, Germany | |
| Contact: Alexandre Assaf | |
| Ludwig-Maximilians University Munich, Klinik und Poliklinik für Mund-, Kiefer und Gesichtschirurgie | Recruiting |
| München, Germany, 80337 | |
| Contact: Sven Otto, PD. Dr. Dr. +49 89 4400 54475 Sven.Otto@med.uni-muenchen.de | |
| Principal Investigator: Sven Otto, PD. Dr. Dr. | |
| Korea, Republic of | |
| Kyungpool National University | Not yet recruiting |
| Daegu, Korea, Republic of | |
| Contact: Tae-Geon KWON | |
| Netherlands | |
| Eramus MC | Not yet recruiting |
| Rotterdam, Netherlands | |
| Contact: Eppo Wolvius | |
| Qatar | |
| Hamad Medical Corporation | Not yet recruiting |
| Doha, Qatar | |
| Contact: Moustafa Alkhalil, MD | |
| Romania | |
| Emergency Clinical County Hospital of Constanta | Recruiting |
| Constanta, Romania | |
| Contact: Adrian Creanga, MD | |
| Slovenia | |
| University Medical Centre Ljubljana | Not yet recruiting |
| Ljubljana, Slovenia | |
| Contact: Dime Sapundzhiev | |
| Spain | |
| 12 de Octubre University Hospital | Recruiting |
| Madrid, Spain | |
| Contact: Gregorio Sanchez Ancieto | |
| University Hospital La Paz de Madrid | Not yet recruiting |
| Madrid, Spain | |
| Contact: Miguel Burgueño | |
| Switzerland | |
| Universitätsspital Basel | Recruiting |
| Basel, Switzerland, 4031 | |
| Contact: Isabelle Berg, Dr. | |
| Luzerner Kantonsspital | Recruiting |
| Luzern, Switzerland | |
| Contact: Andrea Della Chiesa | |
| Universitätsspital Zürich | Recruiting |
| Zürich, Switzerland | |
| Contact: Paul Schumann | |
Sponsors and Collaborators
AO Clinical Investigation and Documentation
AOCMF
Investigators
| Principal Investigator: | Risto Kontio, MD DDS PhD | Helsinki University Central Hospital |
Additional Information:
| Responsible Party: | AO Clinical Investigation and Documentation |
| ClinicalTrials.gov Identifier: | NCT02932501 History of Changes |
| Other Study ID Numbers: |
RP_MRONJ_1.0 |
| First Posted: | October 13, 2016 Key Record Dates |
| Last Update Posted: | January 18, 2019 |
| Last Verified: | January 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by AO Clinical Investigation and Documentation:
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Bisphosphonate Jaw Osteonecrosis Antiresorptive drugs Denosumab |
Additional relevant MeSH terms:
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Osteonecrosis Bisphosphonate-Associated Osteonecrosis of the Jaw Bone Diseases Musculoskeletal Diseases |
Necrosis Pathologic Processes Jaw Diseases Stomatognathic Diseases |