Clinical trial NCT06457776: Medication Related Osteonecrosis of the Jaws (MRONJ) in a Cohort of Patients Treated by Antiresorptive Drugs
Official title: Medication Related Osteonecrosis of the Jaws (MRONJ) in a Cohort of Patients Treated by Antiresorptive Drugs: a Cohort Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteonecrosis of the Jaw
Osteonecrosis Due to Drugs, Jaw
Osteonecrosis Due to Drug
Bisphosphonate-Associated Osteonecrosis
Bisphosphonate-Associated Osteonecrosis of the Jaw
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients starting an antiresorptive drug

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.

Eligibility criteria: Inclusion Criteria:

* Patients with specific prescription to initiate therapy with antiresorptive drugs

Exclusion Criteria:

* Previous Head and Neck Radiotherapy

Primary outcomes:
measure: Medication Related OsteoNecrosis of the Jaws
timeFrame: Five years after the beginning of AR therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Cosimo Rupe
Study officials:
References: