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

Osteonecrosis Due to Drugs, Jaw Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06457776
• Other study ID #: MRONJ-1
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: January 1, 2028

Study information

• Verified date: June 2024
• Source: Catholic University of the Sacred Heart
• Contact: Carlo Lajolo, Prof.
• Phone: 3356078354
• Email: carlo.lajolo[@]unicatt.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: January 1, 2028
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with specific prescription to initiate therapy with antiresorptive drugs

Exclusion Criteria:

• Previous Head and Neck Radiotherapy

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Italy	Cosimo Rupe	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication Related OsteoNecrosis of the Jaws	Incidence of Medication Related OsteoNecrosis of the Jaws	Five years after the beginning of AR therapy