Development of a Predictive Score for Maxillary Osteochimionecrosis After Invasive Oral Surgery in Patients Treated Whith Biphosphonates or Biotherapies: the PREV-ONM Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 45
- 试验地点
- 5
- 主要终点
- occurrence of osteonecrosis of the jaw
研究概览
简要总结
Non-interventional prospective multicentre cohort study to determine a predictive score for the occurrence of osteochimionecrosis of the jaws after invasive oral surgery in patients who have received biphosphonates or antangiogenic drugs as part of chemotherapy with malignant bone disease (multiple myeloma or bone metastasis of a solid tumour).
Data are collected during the usual follow-up of patients during the first 3 months following surgery.
详细描述
Non-interventional prospective multicentre cohort study to determine a predictive score for the occurrence of osteochimionecrosis of the jaws after invasive oral surgery in patients who have received at least one of the following molecules as part of chemotherapy with malignant bone disease (multiple myeloma or bone metastasis of a solid tumour):
- Biphosphonates: ZOLEDRONATE (ZOMETA®), PAMIDRONATE (AREDIA®, OSTEPAM®)
- Anti-angiogenic: DENOSUMAB (XGEVA®), BEVACIZUMAB (AVASTIN®), RITUXIMAB (MABTHERA®, RIXATHON®, TRUXIMA®), SUNITINIB (SUTENT®), PAZOPANIB (VOTRIENT®), AXITINIB (INLYTA®), CARBOZANTINIB (CABOMETYX®, COMETRIQ®), SORAFENIB (NEXAVAR®)
The study protocol is based on the post-operative clinical and radiographic follow-up of patients. 3 consultations are scheduled:
- 1 week after surgery
- 1 month after surgery
- 3 months after surgery
The following information should be noted at each follow-up consultation:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •patients who have received at least one of the following molecules as part of chemotherapy with malignant bone disease (multiple myeloma or bone metastasis of a solid tumour):
- •Biphosphonates: ZOLEDRONATE (ZOMETA®), PAMIDRONATE (AREDIA®, OSTEPAM®)
- •Anti-angiogenic: DENOSUMAB (XGEVA®), BEVACIZUMAB (AVASTIN®), RITUXIMAB (MABTHERA®, RIXATHON®, TRUXIMA®), SUNITINIB (SUTENT®), PAZOPANIB (VOTRIENT®), AXITINIB (INLYTA®), CARBOZANTINIB (CABOMETYX®, COMETRIQ®), SORAFENIB (NEXAVAR®)
- •Patient who has had an oral surgical procedure (single or multiple dental extraction, with or without alveolectomy, under local or general anesthesia)
排除标准
- •History of oral and/or cervico-facial radiotherapy
- •Patient treated successively with biphosphonates and then with anti-angiogenic drugs.
- •Patient under guardianship, curatorship, or imprisonment
- •Patient who has notified his refusal to participate in the research
结局指标
主要结局
occurrence of osteonecrosis of the jaw
时间窗: within 3 months after surgery
occurrence of osteonecrosis of the jaw
次要结局
- Frequency of post-operative healing (bone and gingival) and comparison to each patient's UCONNS score.(within 3 months after surgery)