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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Alexandra Poinas, PhD
- 電話番号：+33 2 53 48 28 57
- メール：alexandra.poinas@chu-nantes.fr
研究連絡先のバックアップ
- 名前：Anne-Gaëlle Chaux, MD, PhD
- 電話番号：02 40 08 33 33
- メール：annegaelle.chaux@chu-nantes.fr
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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.
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Bone Mineral Density Measured on Cone Beam Computed Tomography
時間枠：Baseline and up to 24 months
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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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Trabecular Bone Separation Measured on Cone Beam Computed Tomography
時間枠：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.
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Baseline and up to 24 months
|
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Bone Volume to Total Volume Ratio Measured on Cone Beam Computed Tomography
時間枠：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
|
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Trabecular Bone Number Measured on Cone Beam Computed Tomography
時間枠：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
|
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Hounsfield Unit Values Measured on Cone Beam Computed Tomography
時間枠：Baseline and up to 24 months
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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.
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Baseline and up to 24 months
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協力者と研究者
捜査官
- 主任研究者：Anne-Gaëlle Chaux, MD, PhD、Nantes university hospital
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- AP_AGC_SG_B-ONJ-EVOL
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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