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 range18 Years
SexALL
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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
What they're measuring
1
Treatment outcome
Timeframe: 6 months / 1 year
Trial details
NCT IDNCT02932501
SponsorAO Clinical Investigation and Publishing Documentation