NCT06457776

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 126 (estimated)
• Sponsor: Catholic University of the Sacred Heart · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Dental management	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.

Timeline

• Start date: 2021-01-01
• Primary completion: 2026-01-01
• Completion: 2028-01-01
• First posted: 2024-06-13
• Last updated: 2024-06-20

Locations

1 site across 1 country: Italy