Medication-related Osteonecrosis of the Jaw (MRONJ) Registry

AO Clinical Investigation and Publishing Documentation

Status: Active, not recruiting

Conditions: Bisphosphonate-Associated Osteonecrosis of the Jaw; Medication-related Osteonecrosis of the Jaw

Treatments: Procedure: Conservative treatment; Procedure: Surgical treatment; Procedure: Adjuvant non-surgical treatment

Study type: Observational

Funder types: Other

Identifiers

NCT02932501

RP_MRONJ_1.0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 518 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

518 participants in 1 patient group

MRONJ

Description:

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

Treatment:

Procedure: Conservative treatment

Procedure: Adjuvant non-surgical treatment

Procedure: Surgical treatment