Medication Related Osteonecrosis of the Jaws (MRONJ) in a Cohort of Patients Treated by Antiresorptive Drugs: a Cohort Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Medication Related OsteoNecrosis of the Jaws
研究概览
简要总结
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.
详细描述
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.
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 with specific prescription to initiate therapy with antiresorptive drugs
排除标准
- •Previous Head and Neck Radiotherapy
结局指标
主要结局
Medication Related OsteoNecrosis of the Jaws
时间窗: Five years after the beginning of AR therapy
Incidence of Medication Related OsteoNecrosis of the Jaws
次要结局
未报告次要终点
研究者
Carlo Lajolo
Associate Professor
Catholic University of the Sacred Heart
