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

Last updated: June 17, 2024
Sponsor: Catholic University of the Sacred Heart
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteomyelitis

Bone Neoplasm

Musculoskeletal Diseases

Treatment

Dental management

Clinical Study ID

NCT06457776
MRONJ-1
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with specific prescription to initiate therapy with antiresorptive drugs

Exclusion

Exclusion Criteria:

  • Previous Head and Neck Radiotherapy

Study Design

Total Participants: 126
Treatment Group(s): 1
Primary Treatment: Dental management
Phase:
Study Start date:
January 01, 2021
Estimated Completion Date:
January 01, 2028

Study 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.

Connect with a study center

  • Cosimo Rupe

    Roma, 00168
    Italy

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.