Medication-related Osteonecrosis of the Jaw (MRONJ) Registry | NCT02932501

Studies
Medication-related Osteonecrosis of the Jaw (MRONJ) Registry

NCT02932501

Sponsor

AO Clinical Investigation and Publishing Documentation

Status

Unknown status

Last Update Posted

Mar 20, 2024Actual

Enrollment

518Actual

Phase

Not provided

Conditions

Medication-related Osteonecrosis of the Jaw
Bisphosphonate-Associated Osteonecrosis of the Jaw

Interventions

Conservative treatment
Surgical treatment
Adjuvant non-surgical treatment

Countries

United States
Finland
Germany
Netherlands
Qatar
Romania
Slovenia
South Korea
Spain
Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 14, 2017Actual

Primary Completion Date

Oct 13, 2023Actual

Completion Date

Apr 2024Estimated

First Submitted Date

Oct 12, 2016

First Submission Date that Met QC Criteria

Oct 12, 2016

First Posted Date

Oct 13, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2024

Last Update Posted Date

Mar 20, 2024Actual

Name	Class
AOCMF	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

518Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	Procedure: Conservative treatment Procedure: Surgical treatment Procedure: Adjuvant non-surgical treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Conservative treatment	Procedure	Disinfectant mouth rinses, Antibiotic therapy, Antifungal therapy	MRONJ

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	6 months / 1 year

Secondary Outcomes

Measure	Description	Time Frame
Pain perception	Numeric Rating Scale	6 months / 1 year
Staging of osteonecrosis	Staging of osteonecrosis according to the American Association of Oral and Maxillofacial Surgeons

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients diagnosed of medication-related osteonecrosis of the jaw (MRONJ)

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
University of Kentucky Chandler Medical Center		Lexington	Kentucky	40536	United States
Helsinki University Hospital

ID	Term
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D007571	Jaw Diseases
D009057	Stomatognathic Diseases
D009336	Necrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D000072700	Conservative Treatment
D013514	Surgical Procedures, Operative

ID	Term
D059266	Bisphosphonate-Associated Osteonecrosis of the Jaw
D010020	Osteonecrosis