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NCT Number: NCT06457776

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cosimo Rupe

Roma, 00168, Italy

Location status: Recruiting

Location contact

Carlo Lajolo

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with specific prescription to initiate therapy with antiresorptive drugs

Exclusion criteria

  • Previous Head and Neck Radiotherapy

Treatment and study plan

Dental management

Procedure

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.

Primary outcomes

  1. 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 contacts

Contact information is provided by the study sponsor or research team.

Carlo Lajolo, Prof.

CONTACT

[email protected]

3356078354 ext. +39

Sponsors and collaborators

Lead sponsor

Catholic University of the Sacred Heart

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2028
First posted
Jun 13, 2024
Registry last updated
Jun 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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