JPRN-jRCT2080222390未知2 期
A phase II/III multicenter, randomized, double-blind, parallel group comparative study to evaluate the efficacy and safety of oral administration of NE-58095NF tablets versus once-daily oral administration of NE-58095 2.5-mg tablets for the treatment of involutional osteoporosis
TAKEDA PHARMACEUTICAL COMPANY LTD.0 个研究点目标入组 760 人开始时间: 2014年2月7日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 760
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
- >= 50age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Patients with a diagnosis of involutional osteoporosis
- •- Male or female outpatients (including patients admitted to the hospital for tests) aged >= 50 years at the time of consent
- •- Women for whom at least 2 years has passed since the last natural menstruation
排除标准
- •- Patients with secondary osteoporosis
- •- Patients with diseases (other than secondary osteoporosis) that present with decreased bone mass
- •- Patients with findings that affects the measurement of mean bone mineral density of the lumbar spine by dual-energy X-ray absorptiometry (DXA)
- •- Patients with a history of radiotherapy to the lumbar spine or the pelvis
- •- Patients who are planning to receive surgical dental procedures such as tooth extraction (including dental implant treatment) during the treatment period
- •- Patients with a history of treatment with any anti-RANKL monoclonal antibodies or parathyroid hormone products within 1 year before the start of the treatment period
- •- Patients with a history of treatment with any bisphosphonate products within 24 weeks before the start of the treatment period
- •- Patients who have received any drugs that affect bone metabolism within 8 weeks before the start of the treatment period
- •- Patients with disorders such as esophagitis, peptic ulcer (e.g., esophageal ulcer, gastric ulcer, and duodenal ulcer), or gastrointestinal bleeding
- •- Patients with disorders that delay esophageal emptying (e.g., dysphagia, esophagostenosis, or achalasia of the esophagus)
- •- Patients with hypocalcemia
- •- Patients with hypercalcemia
- •- Patients with a diagnosis of renal calculus
- •- Patients with serious renal, hepatic, or cardiac disease
- •- Patients who have received surgical dental procedures, such as a tooth extraction (including dental implant treatment), but whose dental problems remain unresolved at the start of the treatment period
研究者
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A phase II/III multicenter, randomized, double-blind, parallel group comparative study to evaluate the efficacy and safety of oral administration of NE-58095NF tablets versus once-daily oral administration of NE-58095 2.5-mg tablets for the treatment of involutional osteoporosisInvolutional osteoporosisJPRN-jRCT2080222389Ajinomoto Pharmaceuticals Co., Ltd.760
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