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

Recruiting

• Conditions: Osteonecrosis Due to Drug; Osteonecrosis Due to Drugs, Jaw; Bisphosphonate-Associated Osteonecrosis; Osteonecrosis of the Jaw; Bisphosphonate-Associated Osteonecrosis of the Jaw
• Interventions: Procedure: Dental management

• Registration Number: NCT06457776
• Lead Sponsor: Catholic University of the Sacred Heart

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.

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.

Study Timeline

• Study Start: 2021-01-01
• Status Verified: 2024-06
• Study First Submitted: 2024-06-08
• Study First Submitted QC: 2024-06-08
• Study First Posted: 2024-06-13
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-20
• Primary Completion: 2026-01-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

• Patients with specific prescription to initiate therapy with antiresorptive drugs

Exclusion Criteria

• Previous Head and Neck Radiotherapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Antiresorptive Drugs	Dental management	Patients treated by means of Antiresorptive drugs due to either bone metastasis or metabolic diseases

Primary Outcome Measures

Name	Time	Method
Medication Related OsteoNecrosis of the Jaws	Five years after the beginning of AR therapy	Incidence of Medication Related OsteoNecrosis of the Jaws

Trial Locations

Locations (1)

Cosimo Rupe; 🇮🇹 Roma, Italy