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Clinical Trials/NCT06457776
NCT06457776
Recruiting
Not Applicable

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

Catholic University of the Sacred Heart1 site in 1 country126 target enrollmentJanuary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteonecrosis of the Jaw
Sponsor
Catholic University of the Sacred Heart
Enrollment
126
Locations
1
Primary Endpoint
Medication Related OsteoNecrosis of the Jaws
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2021
End Date
January 1, 2028
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Carlo Lajolo

Associate Professor

Catholic University of the Sacred Heart

Eligibility Criteria

Inclusion Criteria

  • Patients with specific prescription to initiate therapy with antiresorptive drugs

Exclusion Criteria

  • Previous Head and Neck Radiotherapy

Outcomes

Primary Outcomes

Medication Related OsteoNecrosis of the Jaws

Time Frame: Five years after the beginning of AR therapy

Incidence of Medication Related OsteoNecrosis of the Jaws

Study Sites (1)

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