Medication Related Osteonecrosis of the Jaws (MRONJ) in a... | NCT06457776

Studies
Medication Related Osteonecrosis of the Jaws (MRONJ) in a Cohort of Patients Treated by Antiresorptive Drugs

NCT06457776

Sponsor

Catholic University of the Sacred Heart

Status

Recruiting

Last Update Posted

Jun 20, 2024Actual

Enrollment

126Estimated

Phase

Not provided

Conditions

Osteonecrosis of the Jaw
Osteonecrosis Due to Drugs, Jaw
Osteonecrosis Due to Drug
Bisphosphonate-Associated Osteonecrosis
Bisphosphonate-Associated Osteonecrosis of the Jaw

Interventions

Dental management

Countries

Italy

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

Jun 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Jan 1, 2026Estimated

Completion Date

Jan 1, 2028Estimated

First Submitted Date

Jun 8, 2024

First Submission Date that Met QC Criteria

Jun 8, 2024

First Posted Date

Jun 13, 2024Actual

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

Jun 17, 2024

Last Update Posted Date

Jun 20, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Carlo Lajolo, Associate Professor, Catholic University of the Sacred HeartPrincipal Investigator

Lead Sponsor

Catholic University of the Sacred HeartOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

The objective of this prospective observational study is to investigate the incidence of Medication Related Osteonecrosis of the Jaws (MRONJ) in patients receiving antiresorptive drugs for oncohematologic reasons during a 5-year follow-up. Secondary objectives are to compare the different antiresorptive drugs in relation to the incidence of MRONJ and to identify any systemic as well as local risk factors.

Detailed Description

Antiresorptive drugs are widely used for the prevention and treatment of numerous diseases involving the skeletal system. In particular, they have been shown to be effective in reducing the incidence of skeletal events in oncohematologic patients.

Specifically, bone represents a highly affected site of metastatic cancer (i.e., bone metastases from solid tumors of various origins--breast, prostate, renal; multiple myeloma). In the United States, approximately 400,000 individuals suffer from bone metastasis. The most frequent skeletal complications in patients with bone metastases (referred to as SRE - skeletal-related events - in the international literature) include pathologic fractures, spinal cord compression, malignant hypercalcemia, and the need to undergo radiation therapy or surgery on the bone lesion.The introduction of anti-bone resorption drugs (bisphosphonates and denosumab) has reduced the rate of skeletal complications by 30-50% so they are indicated in the management of the oncohematology patient.

Conditions Module

Conditions

Osteonecrosis of the Jaw
Osteonecrosis Due to Drugs, Jaw
Osteonecrosis Due to Drug
Bisphosphonate-Associated Osteonecrosis
Bisphosphonate-Associated Osteonecrosis of the Jaw

Keywords

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

126Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Antiresorptive Drugs		Patients treated by means of Antiresorptive drugs due to either bone metastasis or metabolic diseases	Procedure: Dental management

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dental management	Procedure	The oral conditions of the included patients will be evaluated at baseline. When indicated, dental extractions will be performed before the beginning of Antiresorptive Therapy. Patients will then receive a six-months intervals follow-up, during which primary and secondary prevention of dental diseases will be performed.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Medication Related OsteoNecrosis of the Jaws	Incidence of Medication Related OsteoNecrosis of the Jaws	Five years after the beginning of AR therapy

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with specific prescription to initiate therapy with antiresorptive drugs

Exclusion Criteria:

Previous Head and Neck Radiotherapy

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 starting an antiresorptive drug

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Carlo Lajolo, Prof.	Contact	3356078354	+39	carlo.lajolo@unicatt.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cosimo Rupe	Recruiting	Roma		00168	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41327109	Derived	Rupe C, Gioco G, Tranfa M, Scilla F, Schiavelli A, Cairo F, Galli J, Scambia G, Rengo C, Lajolo C. Differences in oral health status between cancer patients: a case-control observational study. BMC Oral Health. 2025 Dec 1;25(1):1862. doi: 10.1186/s12903-025-06963-7.

ID	Term
D010020	Osteonecrosis
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
D020399	Practice Management
D011364	Professional Practice
D009934	Organization and Administration
D006298	Health Services Administration