Bone Quality Evolution in Medication-Related Osteonecrosis of the Jaw Assessed by CBCT (B-ONJ EVOL) (B-ONJ EVOL)
Evolution of Bone Quality in Medication-Related Osteonecrosis of the Jaw: A Retrospective Multicenter Study Using Cone Beam Computed Tomography (CBCT)
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.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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:
Bone volume to total volume ratio (BV/TV) Trabecular number (Tb.N) Trabecular separation (Tb.Sp) Hounsfield units (HU), when applicable
Data will be collected retrospectively from clinical records and imaging databases across multiple centers. All data will be pseudonymized prior to analysis.
Statistical analyses will be descriptive. Quantitative variables will be expressed as mean ± standard deviation or median with interquartile range, depending on distribution. Qualitative variables will be presented as frequencies and percentages. Comparisons between subgroups may be performed using appropriate statistical tests (Chi-square or Fisher's exact test for categorical variables, Student's t-test or Mann-Whitney test for continuous variables), with a significance level set at p < 0.05.
The study is conducted in accordance with applicable data protection regulations (MR-004 framework), with minimal risk to participants, as it involves retrospective analysis of existing clinical and imaging data.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Alexandra Poinas, PhD
- Номер телефона: +33 2 53 48 28 57
- Электронная почта: alexandra.poinas@chu-nantes.fr
Учебное резервное копирование контактов
- Имя: Anne-Gaëlle Chaux, MD, PhD
- Номер телефона: 02 40 08 33 33
- Электронная почта: annegaelle.chaux@chu-nantes.fr
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
|
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.
|
Cone beam computed tomography (CBCT) imaging is used to assess bone mineral density, trabecular structure, and morphometric characteristics of the jaw in patients with medication-related osteonecrosis of the jaw.
Imaging data are retrospectively analyzed without any additional procedure performed for research purposes.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Bone Mineral Density Measured on Cone Beam Computed Tomography
Временное ограничение: 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.
|
Baseline and up to 24 months
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Trabecular Bone Separation Measured on Cone Beam Computed Tomography
Временное ограничение: Baseline and up to 24 months
|
Trabecular bone separation (Tb.Sp), expressed in millimeters, measured on cone beam computed tomography (CBCT) scans using 3D Slicer software at diagnosis and during follow-up.
Higher values indicate greater trabecular separation.
|
Baseline and up to 24 months
|
|
Bone Volume to Total Volume Ratio Measured on Cone Beam Computed Tomography
Временное ограничение: Baseline and up to 24 months
|
Bone volume to total volume ratio (BV/TV), expressed as a percentage, measured on cone beam computed tomography (CBCT) scans using 3D Slicer software at diagnosis and during follow-up.
Higher values indicate a greater proportion of bone volume.
|
Baseline and up to 24 months
|
|
Trabecular Bone Number Measured on Cone Beam Computed Tomography
Временное ограничение: Baseline and up to 24 months
|
Trabecular bone number (Tb.N), expressed in mm-¹, measured on cone beam computed tomography (CBCT) scans using 3D Slicer software at diagnosis and during follow-up.
Higher values indicate a greater number of trabeculae.
|
Baseline and up to 24 months
|
|
Hounsfield Unit Values Measured on Cone Beam Computed Tomography
Временное ограничение: Baseline and up to 24 months
|
Hounsfield unit (HU) values measured on cone beam computed tomography (CBCT) scans using 3D Slicer software, when applicable, at diagnosis and during follow-up.
Higher values indicate greater radiologic density.
|
Baseline and up to 24 months
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Anne-Gaëlle Chaux, MD, PhD, Nantes university hospital
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- AP_AGC_SG_B-ONJ-EVOL
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .