JPRN-jRCT1041200059暂停2 期
Efficacy of the combination therapy with Eldecalcitol and Ibandronate sodium for the patients with postoperative osteoporosis after gastrectomy due to gastric cancer
Murakami Hideki0 个研究点目标入组 70 人开始时间: 2020年11月6日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- 入组人数
- 70
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
- >= 20age old 至 < 85age old（—）
- 性别
- All
入选标准
- •(1) Patients who have undergone gastrectomy due to gastric cancer (total gastrectomy / partial gastrectomy)
- •(2) Patients with prevalent bone fracture(s) in vertebrae or proximal femora. Or, cases in which the lumbar spine bone mineral density is less than 80% of the average [YAM in proximal femur is substituted for elderly patients with severe deformity in vertebrae]
- •(3) Patients whose general condition is relatively maintained with PS (Performance Status) 0-2
- •(4) Patients whose registration date is 20 years old or older and under 85 years old
- •(5) Within 6 months after surgery
- •(6) The latest inspection value within 14 days before registration satisfies all of the following.
- •Neutrophil count over 1,500 / ul
- •Platelet count over 100000 / ul
- •Total bilirubin under 1.5 mg / dL
- •AST (GOT) under 100 IU / L
- •ALT (GPT) under 100 IU / L
- •Serum creatinine under 1.5 mg / dL
- •Corrected Ca value under 10.5 mg / dL
- •(7) Written consent has been obtained from the individual for participation in this research
排除标准
- •(1) When the surgical scope extends to organs other than the stomach (esophagus, pancreas, etc.)
- •(2) Patients in a long-term immobility state
- •(3) Pregnant women, women who may be pregnant and lactating women
- •(4) Patients with a history of jaw bone necrosis or high risk
- •(5) Patients with hypo / hypercalcemia
- •(6) Patients with urethral stones
- •(7) Patients with a history of hypersensitivity to the ingredients of the drug used
- •(8) Patients with distant metastasis (including patients with positive ascites cytology) at the time of registration
- •(9) Patients with significant loss of appetite
- •(10) Patients diagnosed with secondary osteoporosis
- •(11) Patients who have been diagnosed and treated for osteoporosis at the time of registration
- •(12) Other patients that the doctor in charge deems inappropriate
研究者
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