Clinical Trial: Medication-related Osteonecrosis of the Jaw (MRONJ) Registry

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational [Patient 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

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 Summary: 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.
Sponsor: AO Clinical Investigation and Documentation

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pain [ 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.


Original Secondary Outcome: Same as current

Information By: AO Clinical Investigation and Documentation

Dates:
Date Received: October 12, 2016
Date Started: June 2017
Date Completion: September 2021
Last Updated: May 2, 2017
Last Verified: May 2017