Medication-related Osteonecrosis of the Jaw (MRONJ) Registry (NCT02932501) | Clinical Trial Compass
UnknownNot Applicable
Medication-related Osteonecrosis of the Jaw (MRONJ) Registry
United States, Finland, Germany518 participantsStarted 2017-08-14
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Treatment outcome
Timeframe: 6 months / 1 year
Trial details
NCT IDNCT02932501
SponsorAO Clinical Investigation and Publishing Documentation