Clinical trial NCT02932501: Medication-related Osteonecrosis of the Jaw (MRONJ) Registry
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Medication-related Osteonecrosis of the Jaw
Bisphosphonate-Associated Osteonecrosis of the Jaw
Keywords: Bisphosphonate
Jaw
Osteonecrosis
Antiresorptive drugs
Denosumab
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
Collaborators: name: AOCMF
First posted: 2016-10-13
Enrollment: 518
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed of medication-related osteonecrosis of the jaw (MRONJ)

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.

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.

Eligibility 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
* 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

Primary outcomes:
measure: Treatment outcome
timeFrame: 6 months / 1 year
Secondary outcomes:
measure: Pain perception
timeFrame: 6 months / 1 year
measure: Staging of osteonecrosis
timeFrame: 6 months / 1 year
measure: Site and size of the lesion
timeFrame: 6 months / 1 year
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky Chandler Medical Center
state: Kentucky
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Hamburg
country: Germany
facility: Universitätskliniken Eppendorf
city: München
country: Germany
facility: Ludwig-Maximilians University Munich, Klinik und Poliklinik für Mund-, Kiefer und Gesichtschirurgie
city: Daegu
country: Korea, Republic of
facility: Kyungpool National University
city: Rotterdam
country: Netherlands
facility: Eramus MC
city: Doha
country: Qatar
facility: Hamad Medical Corporation
city: Constanta
country: Romania
facility: Emergency Clinical County Hospital of Constanta
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
city: Madrid
country: Spain
facility: 12 de Octubre University Hospital
city: Basel
country: Switzerland
facility: Universitätsspital Basel
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
Study officials:
affiliation: Helsinki University Central Hospital
name: Risto Kontio, MD DDS PhD
role: PRINCIPAL_INVESTIGATOR
References: