NCT01488851已完成不适用
Prospective Observational Multi Central Cohort Study to Assess the Incidence of Osteo Necrosis of Jaw in Patients With Bone Metastasis Starting Zoledronic Acid Treatment
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
Prospective observational multi central cohort study to assess the incidence of osteo necrosis of jaw in cancer patient with bone metastasis starting Zoledronic acid treatment
详细描述
Prospective observational multi central cohort study to assess the incidence of osteo necrosis of jaw (ONJ) in pts with bone metastasis starting Zoledronic acid treatment
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bone metastasis from multiple myeloma, solid tumors, or other malignancy for which intravenous bisphosphonate has clinical indications in the treatment of metastatic bone disease.
- •All participants must be planning to receive zoledronic acid (as their sole bisphosphonate therapy) within 30 days after registration. Patients previously treated with bisphosphonate therapy are eligible if the following criteria apply:
- •Patients may have previously received at most 3 doses of intravenous bisphosphonate therapy with ibandronate, pamidronate or zoledronic acid for low bone mass (osteopenia or osteoporosis) within 3 years prior to registration or
- •Patients may have received intravenous bisphosphonate therapy with ibandronate, pamidronate or zoledronic acid to treat metastatic bone disease within 90 days prior to registration. Patients receiving any of these regimens for metastatic bone disease prior to 90 days before registration are not eligible, or c. Prior oral bisphosphonate therapy at any time prior to registration is allowed.
- •No pre-existing diagnosis of ONJ.
- •No history of radiation to the maxillofacial area administered for therapeutic intent in the treatment of cancer.
- •Zubrod performance status of 0-
- •Willing and physically able to comply with the study procedures and assessments.
- •Can concurrently participate in other therapeutic and non-therapeutic clinical trials.
- •No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.
- •Must be informed of the investigational nature of this study and must sign and give written informed consent.
排除标准
- 未提供
研究者
研究点 (1)
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