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

NCT06457776 | Recruiting

• 1 other identifier: MRONJ-1
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Medication Related OsteoNecrosis of the Jaws

  Incidence of Medication Related OsteoNecrosis of the Jaws

  Five years after the beginning of AR therapy

Study Arms (1)

Antiresorptive Drugs

Patients treated by means of Antiresorptive drugs due to either bone metastasis or metabolic diseases

Procedure: Dental management

Interventions

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.

Antiresorptive Drugs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients starting an antiresorptive drug

You may qualify if:

• Patients with specific prescription to initiate therapy with antiresorptive drugs

You may not qualify if:

• Previous Head and Neck Radiotherapy

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Cosimo Rupe

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Bisphosphonate-Associated Osteonecrosis of the Jaw

Interventions

Practice Management, Dental

Condition Hierarchy (Ancestors)

Osteonecrosis; Bone Diseases; Musculoskeletal Diseases; Jaw Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Practice Management; Professional Practice; Organization and Administration; Health Services Administration

Central Study Contacts

Carlo Lajolo, Prof.

CONTACT

3356078354; carlo.lajolo@unicatt.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 8, 2024
• First Posted: June 13, 2024
• Study Start: January 1, 2021
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2028
• Last Updated: June 20, 2024

Record last verified: 2024-06

Locations

IT (1)