JPRN-jRCTs051180011招募中3 期
Efficacy on zoledronate therapy for diffuse sclerosing osteomyelitis of the mandible - Efficacy on zoledronate therapy for diffuse sclerosing osteomyelitis of the mandible
Akashi Masaya0 个研究点目标入组 8 人开始时间: 2018年12月4日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •The patient meets all the following criteria to qualify.
- •(1) During informed consent in patients is over 18 years old.
- •(2) Patients with clinical symptoms, panoramic x-rays, mandible CT or MRI findings and blood examinations, was diagnosed with the DSO.
- •(3) Participation in this study, patients with written consent by the free will of the person in question.
排除标准
- •As to exclude patients with any one of the following.
- •(1)Patients not diagnosed with the DSO, based on clinical symptoms, panoramic x-rays, mandible CT or MRI findings and blood tests showed.
- •(2) Before blood tests on patients under serum Ca 8.6 mg/dl.
- •(3) Patients with severe liver dysfunction (serum AST or ALT values> 70 IU / l or T-BIL> 2.0 mg / dl)
- •(4) Patients with severe renal dysfunction (eGFR <30 ml / min).
- •(5)Patients with drug hypersensitivity such as allergies.
- •(6)QT prolongation due to hypocalcemia, cramps, tetany, numbness, disorientation history of recognition, etc.
- •(7)Patients with complications of medication-related osteonecrosis of the jaw or history.
- •(8)Patients with a bisphosphonate dose history for DSO within 2 years.
- •(9)Patients during administration of a bisphosphonate or Denosumab or a dose history for diseases except DSO.
- •(10)Patients with risk factors for drug-related bone necrosis listed below
- •malignant tumors, angiogenesis inhibitors, corticosteroids treatment, radiation therapy
- •(11) Patients with otitis externa, ear discharge, the symptoms of ear pain, etc.
- •(12)Patients using calcitonin preparations, aminoglycoside antibiotics, cinacalcet.
- •(13) Pregnant women and patients who may be pregnant or breast-feeding patients.
- •(14)Patients who participated in other clinical trials within 4 months.
- •(15)In addition, patients judged inappropriate by the person in charge of this study.
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