EUCTR2008-006154-17-CZ进行中（未招募）不适用
An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety ofDenosumab (AMG162) in the Treatment of Bone Loss in Subjects UndergoingAndrogen-Deprivation Therapy for Non-metastatic Prostate Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 803
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •Subjects must be currently participating in the 20040138 study
- •Subjects must sign the informed consent before any study specific procedures
- •are performed
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects with any prior diagnosis of bone metastasis
- •Known hypocalcemia
- •Developed sensitivity to mammalian cell derived drug products during the
- •20040138 study
- •Currently receiving any investigational product other than denosumab or having
- •received any investigational product during the 20040138 study
- •Any disorder that, in the opinion of the investigator, may compromise the ability of
- •the subject to give written informed consent and/or comply with study procedures
研究者
相似试验
进行中（未招募）
不适用
An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab Administration in Postmenopausal Women with Low Bone DensityTreatment of postmenopausal osteoporosisMedDRA version: 17.0Level: PTClassification code 10031285Term: Osteoporosis postmenopausalSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2007-001041-17-EEAmgen Inc.5,600
进行中（未招募）
不适用
An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab Administration in Postmenopausal Women with Low Bone DensityTreatment of postmenopausal osteoporosisMedDRA version: 17.1Level: PTClassification code 10031285Term: Osteoporosis postmenopausalSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2007-001041-17-LTAmgen Inc.5,600
进行中（未招募）
不适用
An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab Administration in Postmenopausal Women with Low Bone DensityTreatment of postmenopausal osteoporosisMedDRA version: 17.1Level: PTClassification code 10031285Term: Osteoporosis postmenopausalSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2007-001041-17-CZAmgen Inc.5,600
进行中（未招募）
不适用
An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab Administration in Postmenopausal Women with Low Bone DensityEUCTR2007-001041-17-DKAmgen Inc.5,600
进行中（未招募）
不适用
An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab Administration in Postmenopausal Women with Low Bone DensityTreatment of postmenopausal osteoporosisMedDRA version: 17.0Level: PTClassification code 10031285Term: Osteoporosis postmenopausalSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2007-001041-17-SEAmgen Inc.5,600