An observational study in Medication-related Osteonecrosis of the Jaw and Bisphosphonate-Associated Osteonecrosis of the Jaw, sponsored by AO Clinical Investigation and Publishing Documentation. Active, not recruiting at 14 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-20.
Sponsored by AO Clinical Investigation and Publishing Documentation · Observational
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.
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.
286 studies on the registry are indexed under Osteonecrosis; 45 are open to participants now.
This study's enrollment of 518 is above the median of 121 across 127 observational studies indexed under Osteonecrosis.
Browse Osteonecrosis studies →AO Clinical Investigation and Publishing Documentation is the lead sponsor of 50 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients diagnosed of medication-related osteonecrosis of the jaw (MRONJ)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Newly diagnosed patients with exposed MRONJ, i.e:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Disinfectant mouth rinses, Antibiotic therapy, Antifungal therapy
Superficial debridement, Complete removal of necrotic bone, Complete bone resection, When applicable revision and soft tissue coverage
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
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
Time frame: 6 months / 1 year
Pain perception
Numeric Rating Scale
Time frame: 6 months / 1 year
Staging of osteonecrosis
Staging of osteonecrosis according to the American Association of Oral and Maxillofacial Surgeons
Time frame: 6 months / 1 year
Site and size of the lesion
Site (single vs. multiple) and size of the lesion according to Weitzman et al.
Time frame: 6 months / 1 year
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2017 to primary completion in Oct 2023, 73 months.
Of 59 observational studies under Osteonecrosis, half reached primary completion within 141 months of starting (the median), counting those still running; a quarter within 93 and three quarters within 184. This study's 73 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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AO Clinical Investigation and Publishing Documentation