Evolution of Bone Quality in Medication-Related Osteonecrosis of the Jaw: A Retrospective Multicenter Study Using Cone Beam Computed Tomography (CBCT)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 25
- 主要终点
- Bone Mineral Density Measured on Cone Beam Computed Tomography
研究概览
简要总结
Medication-related osteonecrosis of the jaw (MRONJ) is a known complication of antiresorptive therapies such as bisphosphonates and denosumab. It can lead to bone damage in the jaw, with variable clinical outcomes depending on disease stage and management.
Cone Beam Computed Tomography (CBCT) is currently recommended for diagnosis and follow-up of MRONJ. However, most studies rely on qualitative or descriptive imaging findings, and little is known about how bone quality evolves over time using quantitative imaging parameters.
This retrospective multicenter study aims to describe the evolution of bone quality in patients with MRONJ using CBCT imaging. Bone parameters such as bone mineral density and trabecular structure will be measured at diagnosis and during follow-up.
The study will help improve understanding of bone changes over time in MRONJ and may contribute to better assessment and management of the disease.
详细描述
Medication-related osteonecrosis of the jaw (MRONJ) is a serious adverse effect associated with antiresorptive therapies, including bisphosphonates and anti-RANKL monoclonal antibodies. It is characterized by necrotic bone lesions of the jaw, often triggered by dental procedures, and is associated with significant morbidity.
Current imaging evaluation relies primarily on Cone Beam Computed Tomography (CBCT), which is recommended for both diagnosis and follow-up. However, most published studies provide only qualitative or descriptive assessments of bone lesions. Quantitative and longitudinal analyses of bone microarchitecture remain limited.
This retrospective, multicenter, observational study aims to describe the evolution of bone quality in patients with MRONJ managed according to current clinical guidelines.
The primary objective is to evaluate changes in bone mineral density (BMD) measured on CBCT scans at diagnosis and during follow-up.
Secondary objectives include longitudinal assessment of bone morphometric parameters using CBCT imaging and dedicated software (3D Slicer), including:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient aged 18 years or older
- •Diagnosis of medication-related osteonecrosis of the jaw (MRONJ), stage 0, 1, or 2
- •Available diagnostic CBCT and at least 2 follow-up cone beam computed tomography (CBCT) examinations
- •Able to understand the study information and not opposed to participation
排除标准
- •Other jaw bone disease
- •History of cervicofacial irradiation
- •Stage 3 medication-related osteonecrosis of the jaw
- •Fewer than 2 follow-up cone beam computed tomography (CBCT) examinations
研究组 & 干预措施
Patients With Medication-Related Osteonecrosis of the Jaw
Patients diagnosed with medication-related osteonecrosis of the jaw (MRONJ) included in a retrospective multicenter cohort. Data are collected from clinical records and cone beam computed tomography (CBCT) imaging to assess bone characteristics and disease evolution.
干预措施: Cone Beam Computed Tomography Imaging (Diagnostic Test)
结局指标
主要结局
Bone Mineral Density Measured on Cone Beam Computed Tomography
时间窗: Baseline and up to 24 months
Bone mineral density assessed on cone beam computed tomography (CBCT) scans at diagnosis and on follow-up scans during clinical management of medication-related osteonecrosis of the jaw. Higher values indicate greater bone mineral density.
次要结局
- Trabecular Bone Separation Measured on Cone Beam Computed Tomography(Baseline and up to 24 months)
- Bone Volume to Total Volume Ratio Measured on Cone Beam Computed Tomography(Baseline and up to 24 months)
- Trabecular Bone Number Measured on Cone Beam Computed Tomography(Baseline and up to 24 months)
- Hounsfield Unit Values Measured on Cone Beam Computed Tomography(Baseline and up to 24 months)