Investigating jaw bone issues in patients on antiresorptive drugs
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 Heart · NCT06457776
This study is trying to see how often jaw bone problems happen in cancer patients taking certain medications to help with bone issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 126 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Catholic University of the Sacred Heart (other) |
| Drugs / interventions | denosumab, radiation |
| Locations | 1 site (Roma) |
| Trial ID | NCT06457776 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the incidence of Medication Related Osteonecrosis of the Jaws (MRONJ) in patients receiving antiresorptive drugs for oncohematologic conditions over a five-year period. It will also compare the incidence of MRONJ among different antiresorptive medications and identify both systemic and local risk factors associated with this condition. The study focuses on patients who are prescribed these drugs to manage skeletal complications related to cancer. By following these patients, researchers hope to gather valuable data on the safety and risks of antiresorptive therapies.
Who should consider this trial
Good fit: Ideal candidates are patients who have been prescribed antiresorptive drugs for oncohematologic reasons.
Not a fit: Patients who have previously undergone head and neck radiotherapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of MRONJ and improve management strategies for patients receiving antiresorptive therapy.
How similar studies have performed: Other studies have indicated varying success in understanding MRONJ, but this specific approach focusing on antiresorptive drugs in oncohematologic patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with specific prescription to initiate therapy with antiresorptive drugs Exclusion Criteria: * Previous Head and Neck Radiotherapy
Where this trial is running
Roma
- Cosimo Rupe — Roma, Italy (RECRUITING)
Study contacts
- Study coordinator: Carlo Lajolo, Prof.
- Email: carlo.lajolo@unicatt.it
- Phone: 3356078354
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Osteonecrosis of the Jaw, Osteonecrosis Due to Drugs, Jaw, Osteonecrosis Due to Drug, Bisphosphonate-Associated Osteonecrosis, Bisphosphonate-Associated Osteonecrosis of the Jaw