Medication-related Osteonecrosis of the JawMRONJNCT02932501
Medication-related Osteonecrosis of the Jaw (MRONJ) Registry
An observational study of Medication-related Osteonecrosis of the Jaw and Bisphosphonate-Associated Osteonecrosis of the Jaw, run by AO Clinical Investigation and Publishing Documentation at 14 sites in 10 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication-related Osteonecrosis of the Jaw, Bisphosphonate-Associated Osteonecrosis of the Jaw
- What is being tested?
- Conservative treatment, Surgical treatment and Adjuvant non-surgical treatment
- Type of treatment
- Surgery or procedure
- How many people
- 518 participants
- Where
- 14 sitesin 10 countries
- Study dates
- 14 Aug 2017to Apr 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed of medication-related osteonecrosis of the jaw (MRONJ)
Who may be able to join
- 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
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- 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
Who cannot join
- 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 locations and contacts
14 sites in 10 countries.
14 sites in 10 countries
Germany3 sites
Charité - Universitätsmedizin Berlin
Berlin
Universitätskliniken Eppendorf
Hamburg
Ludwig-Maximilians University Munich, Klinik und Poliklinik für Mund-, Kiefer und Gesichtschirurgie
München, 80337
Switzerland3 sites
Universitätsspital Basel
Basel, 4031
Luzerner Kantonsspital
Lucerne
Universitätsspital Zürich
Zurich
United States1 site
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536
About this study
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
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.
Read the 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.
- Conditions
- Medication-related Osteonecrosis of the Jaw, Bisphosphonate-Associated Osteonecrosis of the Jaw
- Being tested
- Conservative treatment, Surgical treatment, Adjuvant non-surgical treatment
- Keywords
- Bisphosphonate, Jaw, Osteonecrosis, Antiresorptive drugs, Denosumab
- Medical subject headings
- Bisphosphonate-Associated Osteonecrosis of the Jaw, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative treatmentProcedure or surgery
Disinfectant mouth rinses, Antibiotic therapy, Antifungal therapy
Surgical treatmentProcedure or surgery
Superficial debridement, Complete removal of necrotic bone, Complete bone resection, When applicable revision and soft tissue coverage
Adjuvant non-surgical treatmentProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| MRONJ | 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 Receives: Procedure: Conservative treatment; Procedure: Surgical treatment; Procedure: Adjuvant non-surgical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment outcome
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
Measured: 6 months / 1 year
Secondary outcomes (3)
Pain perception
Numeric Rating Scale
Measured: 6 months / 1 year
Staging of osteonecrosis
Staging of osteonecrosis according to the American Association of Oral and Maxillofacial Surgeons
Measured: 6 months / 1 year
Site and size of the lesion
Site (single vs. multiple) and size of the lesion according to Weitzman et al.
Measured: 6 months / 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study start14 Aug 2017
- Primary completion13 Oct 2023
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication-related Osteonecrosis of the JawStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 518 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Collaborators
- AOCMF
- Responsible party
- Sponsor
- Investigators
- Risto Kontio, MD DDS PhD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02932501
- Sponsor's protocol ID
- RP_MRONJ_1.0
- Acronym
- MRONJ
- Status last verified
- Mar 2024
- First submitted
- 12 Oct 2016
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02932501
- Acronym / sponsor ID
- MRONJ / RP_MRONJ_1.0
- Conditions
- Medication-related Osteonecrosis of the Jaw, Bisphosphonate-Associated Osteonecrosis of the Jaw
- Keywords
- Bisphosphonate, Jaw, Osteonecrosis, Antiresorptive drugs, Denosumab
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 518 participants (actual)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Collaborators
- AOCMF
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 13 Oct 2023 (actual)
- Study completion
- Apr 2024 (estimated)
- First posted
- 13 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRONJ | – | Procedure: Conservative treatment, Procedure: Surgical treatment, Procedure: Adjuvant non-surgical treatmentPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed of medication-related osteonecrosis of the jaw (MRONJ)
Key inclusion criteria (11 listed)
- 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:
- Ability to understand the content of the patient information/ Informed Consent Form
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conservative treatmentDisinfectant mouth rinses, Antibiotic therapy, Antifungal therapy | Procedure or surgery | MRONJ |
| Surgical treatmentSuperficial debridement, Complete removal of necrotic bone, Complete bone resection, When applicable revision and soft tissue coverage | Procedure or surgery | MRONJ |
| Adjuvant non-surgical treatmentHyperbaric 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 | Procedure or surgery | MRONJ |
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
3 secondary outcomes
Pain perception
Time frame: 6 months / 1 year
Staging of osteonecrosis
Time frame: 6 months / 1 year
Site and size of the lesion
Time frame: 6 months / 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Medication-related Osteonecrosis of the Jaw
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Autologous Platelet Concentrates on the Healing of Extraction Sockets
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Comparing Implant Retention Versus Removal for MRONJ at Implant Sites
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Topical Oxygen Therapy for BRONJ
Bisphosphonate Related Osteonecrosis of the Jaws (BRONJ), Oxygen
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Early Warning and Risk Prediction of Medication-Related Osteonecrosis of the Jaw
Medication-related Osteonecrosis of the Jaw (MRONJ)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Risto Kontio, MD DDS PhD principal investigator
Helsinki University Central Hospital
14 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medication-related Osteonecrosis of the Jaw and Bisphosphonate-Associated Osteonecrosis of the Jaw, run by AO Clinical Investigation and Publishing Documentation at 14 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Germany, Switzerland, United States, Finland, Netherlands and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment outcome (time frame: 6 months / 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.