Current partner codePEPTIDESDE
NCT02932501·Not applicable·OBSERVATIONAL

Medication-related Osteonecrosis of the Jaw (MRONJ) Registry

Status

Unknown

Phase

Not applicable

Enrollment

518

Locations

14

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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 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.

Interventions

Treatment arms and agents.

PROCEDURE

Conservative treatment

Disinfectant mouth rinses, Antibiotic therapy, Antifungal therapy

PROCEDURE

Surgical treatment

Superficial debridement, Complete removal of necrotic bone, Complete bone resection, When applicable revision and soft tissue coverage

PROCEDURE

Adjuvant non-surgical treatment

Hyperbaric oxygen therapy Pentoxifylline and tocopherol Ozone therapy Low level laser therapy Pain relief Anti-inflammatory treatment Platelet rich plasma Parathyroid hormone and teriparatide Bone morphogenetic protein

Timeline

From registration to results.

  1. First posted

    Oct 13, 2016

  2. Study start

    Aug 14, 2017

  3. Primary completion

    Oct 13, 2023

  4. Study completion

    Apr 2024

  5. Results posted

    Not reported

  6. Registry updated

    Mar 20, 2024

Outcomes

What the study measures.

Primary outcomes

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

Secondary outcomes

Pain perception

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.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

Study locations

14 registered sites.

Finland · Germany · Netherlands · Qatar · Romania · Slovenia · South Korea · Spain · Switzerland · United States. Showing up to 24 locations stored in the fast local snapshot.

University of Kentucky Chandler Medical Center

Lexington, Kentucky, United States

Helsinki University Hospital

Helsinki, Finland

Charité - Universitätsmedizin Berlin

Berlin, Germany

Universitätskliniken Eppendorf

Hamburg, Germany

Ludwig-Maximilians University Munich, Klinik und Poliklinik für Mund-, Kiefer und Gesichtschirurgie

München, Germany

Eramus MC

Rotterdam, Netherlands

Hamad Medical Corporation

Doha, Qatar

Emergency Clinical County Hospital of Constanta

Constanța, Romania

University Medical Centre Ljubljana

Ljubljana, Slovenia

Kyungpool National University

Daegu, South Korea

12 de Octubre University Hospital

Madrid, Spain

Universitätsspital Basel

Basel, Switzerland

Luzerner Kantonsspital

Lucerne, Switzerland

Universitätsspital Zürich

Zurich, Switzerland

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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