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