NCT00523341已完成3 期
An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety and Sustained Efficacy of Denosumab (AMG162) in the Treatment of Postmenopausal Osteoporosis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 4,550
- 主要终点
- Number of Participants With Laboratory Toxicities of Grade ≥ 3
研究概览
简要总结
The primary objective was to describe the safety and tolerability of up to 10 years or 7 years denosumab administration as measured by adverse event monitoring, immunogenicity and safety laboratory parameters in participants who previously received denosumab or placebo, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 94 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women who have attended the 20030216 (NCT00089791) study month 36 visit will be eligible to participate if they meet the inclusion and
排除标准
- •given below.
- •Inclusion Criteria
- •Subjects must sign the informed consent before any study specific procedures are performed and agree to receive denosumab 60 mg subcutaneous injection every 6 months
- •Subjects must not have discontinued investigational product during the 20030216 study and must have attended the 20030216 study month 36 visit
- •Subjects must be re-consented prior to (or at) the 24 month visit for participation beyond month
- •Exclusion Criteria
- •Permanently non-ambulatory subjects (use of an assistive device eg, cane, walker, etc. is permitted)
- •Missed 2 or more investigational product doses during the 20030216 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
- •Developed sensitivity to mammalian cell derived drug products during the 20030216 study
- •Unable to tolerate calcium supplementation during the last 6 months of participation in the 20030216 study (between the month 30 and month 36 20030216 study visits)
- •Currently receiving any investigational product other than denosumab or having received any investigational product during the 20030216 study
- •Current use of the following osteoporosis agents: bisphosphonates, calcitonin, fluoride, parathyroid hormone, selective estrogen receptor modulators, systemic oral or transdermal estrogen (except vaginal preparations and estrogen creams which are acceptable), strontium, or tibolone
- •For bone biopsy sub-study subjects only: known or suspected sensitivity or contraindication to tetracycline derivatives
结局指标
主要结局
Number of Participants With Laboratory Toxicities of Grade ≥ 3
时间窗: 84 months
Laboratory toxicity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grade 3 indicates severe toxicity and Grade 4 indicates life-threatening toxicity.
Number of Participants With Adverse Events (AEs)
时间窗: 84 months
A serious adverse event (SAE) is defined as an adverse event that: • is fatal • is life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • is other significant medical hazard. Treatment-related adverse events includes only events for which the investigator indicated there was a reasonable possibility they may have been caused by study drug. The following were classified as adverse events of interest (events that are considered to be identified or potential risks of denosumab treatment): positively adjudicated osteonecrosis of the jaw, positively adjudicated atypical femoral fracture, hypocalcemia, adverse events potentially related to hypersensitivity, serious infection (including bacterial cellulitis), malignancy, cardiac disorders, vascular disorders, fracture healing complications, eczema, acute pancreatitis, and musculoskeletal pain.
Number of Participants With Antibodies to Denosumab
时间窗: Every 12 months through Month 84
次要结局
- Percent Change From Baseline in Lumbar Spine Bone Mineral Density by Visit(Baseline (of extension study) and months 12, 24, 36, 60 and 84)
- Percent Change From Study 20030216 Baseline in Lumbar Spine Bone Mineral Density by Visit(Study 20030216 baseline and extension study months 12, 24, 36, 60 and 84)
- Bone Histomorphometry: Trabecular Thickness(Month 24 and month 84)
- Bone Histomorphometry: Cortical Width(Month 24 and month 84)
- Percent Change From Baseline in Total Hip Bone Mineral Density by Visit(Baseline (of extension study) and months 12, 24, 36, 60 and 84)
- Percent Change From Baseline in Femoral Neck Bone Mineral Density by Visit(Baseline (of extension study) and months 12, 24, 36, 60 and 84)
- Percent Change From Baseline in 1/3 Radius Bone Mineral Density by Visit(Baseline (of extension study) and months 12, 24, 36, 60 and 84)
- Number of Participants With New Vertebral Fractures(84 months)
- Percent Change From Baseline in Albumin-adjusted Serum Calcium at Day 10(Baseline (of extension study) and day 10)
- Serum Denosumab Concentration(Baseline (pre-dose in extension study), day 10, and Months 3, 4 and 6 (pre-dose))
- Bone Histomorphometry: Cancellous Bone Volume(Month 24 and month 84)
- Bone Histomorphometry: Osteoblast - Osteoid Interface(Month 24 and month 84)
- Percent Change From Study 20030216 Baseline in Total Hip BMD by Visit(Study 20030216 baseline and extension study months 12, 24, 36, 60 and 84)
- Percent Change From Study 20030216 Baseline in Femoral Neck BMD by Visit(Study 20030216 baseline and extension study months 12, 24, 36, 60 and 84)
- Percent Change From Study 20030216 Baseline in 1/3 Radius BMD by Visit(Study 20030216 baseline and extension study months 12, 24, 36, 60, and 84)
- Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP) by Visit(Baseline (of extension study), day 10, and months 6, 12, 24, 36, 48, 60, 72, and 84)
- Bone Histomorphometry: Osteoid Thickness(Month 24 and month 84)
- Bone Histomorphometry: Eroded Surface/Bone Surface(Month 24 and month 84)
- Bone Histomorphometry: Single-label Surface(Month 24 and month 84)
- Bone Histomorphometry: Double-label Surface(Month 24 and month 84)
- Bone Histomorphometry: Osteoid Volume(Month 24 and month 84)
- Number of Participants With Non-Vertebral Fractures(84 months)
- Percent Change From Study 20030216 Baseline in CTX-1 by Visit(Study 20030216 Baseline and extension study day 10, and months 6, 12, 24, 36, 48, 60, 72, and 84)
- Percent Change From Study 20030216 Baseline in P1NP by Visit(Study 20030216 Baseline and extension study day 10, and months 6, 12, 24, 36, 48, 60, 72, and 84)
- Bone Histomorphometry: Trabecular Separation(Month 24 and month 84)
- Bone Histomorphometry: Mineral Apposition Rate(Month 24 and month 84)
- Bone Histomorphometry: Formation Period(Month 24 and month 84)
- Bone Histology at Month 84(Month 84)
- Percent Change From Baseline in C-Telopeptide 1 (CTX-1) by Visit(Baseline (of extension study), day 10, and months 6, 12, 24, 36, 48, 60, 72, and 84)
- Bone Histomorphometry: Trabecular Number(Month 24 and month 84)
- Bone Histomorphometry: Cancellous Bone Volume by TRAP Histomorphometry(Month 24 and month 84)
- Bone Histomorphometry: Osteoclast Number by TRAP - Length Based(Month 24 and month 84)
- Bone Histomorphometry: Bone Formation Rate - Surface Based(Month 24 and month 84)
- Bone Histomorphometry: Activation Frequency(Month 24 and month 84)
- Bone Histomorphometry: Surface Density(Month 24 and month 84)
- Bone Histomorphometry: Osteoid Surface(Month 24 and month 84)
- Bone Histomorphometry: Osteoclast Number - Surface Based(Month 24 and month 84)
- Bone Histomorphometry: Osteoclast Number by TRAP - Surface Based(Month 24 and month 84)
- Bone Histomorphometry: Mineralizing Surface(Month 24 and month 84)
- Bone Histomorphometry: Adjusted Apposition Rate(Month 24 and month 84)
- Bone Histology at Month 24(Month 24)
- Bone Histomorphometry: Wall Thickness(Month 24 and month 84)
- Bone Histomorphometry: Osteoclast Number - Length Based(Month 24 and month 84)
- Bone Histomorphometry: Bone Formation Rate - Volume Based(Month 24 and month 84)
- Bone Histomorphometry: Mineralization Lag Time(Month 24 and month 84)
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