A Randomized, Double-Blind, Parallel Design, Repeat Dose, 2-arm, Multicenter Study Comparing the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profiles of AVT03 and US-Prolia® in Postmenopausal Women With Osteoporosis, ALVOBOND
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 532
- 试验地点
- 34
- 主要终点
- Percent Change From Baseline in LS BMD at Month 12 to Demonstrate Comparable Efficacy of AVT03 and Prolia®.
研究概览
简要总结
This is a randomized, double-blind, parallel design, repeat dose, 2 arm, multicenter study comparing the efficacy, safety, immunogenicity, pharmacodynamic (PD) and pharmacokinetic (PK) profiles of AVT03 and US-Prolia in postmenopausal women with osteoporosis.
详细描述
After the screening activities, eligible subjects were randomized to receive either AVT03 60 mg or Prolia® 60 mg, administered as a subcutaneous (s.c.) injection on Day 1 and at Month 6. At Month 12, subjects in AVT03 treatment group will received a third dose of AVT03 60 mg administered s.c. while subjects in Prolia® treatment group will were be re-randomized 1:1 to receive either Prolia 60 mg or AVT03 60 mg administered as a subcutaneous injection.
Afterwards, the subjects will be followed until the End of Study (EoS) Visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
AVT03
AVT03 is the proposed biosimilar for Prolia.
干预措施: AVT03 (Biological)
Prolia
干预措施: Denosumab (Biological)
结局指标
主要结局
Percent Change From Baseline in LS BMD at Month 12 to Demonstrate Comparable Efficacy of AVT03 and Prolia®.
时间窗: Baseline to Month 12
Percent Change From Baseline in LS BMD at Month 12 to demonstrate comparable efficacy of AVT03 and Prolia®.
To Demonstrate Comparable Profile of AVT03 and Prolia in Terms of Area Under the Percent Change From Baseline in Serum C-telopeptide of Type 1 Collagen (AUEC of %Cfb sCTX-1)
时间窗: Baseline to Month 6
次要结局
- Frequency and Severity of Findings in Routine Safety Parameters(Month 18)
- Frequency and Severity of Injection Site Reactions(Month 12)
- Percent Change From Baseline in Hip and Femoral Neck BMD(Month 6, Month 12, Month 18)
- Incidence of New Morphometric Vertebral Fractures(Month 12 and 18)
- Percent Change From Baseline in sCTX-1(Month 3, Month 6, Month 9, Month 12 and Month 18)
- Incidence, Nature and Severity of Adverse Events Including Adverse Drug Reactions(Month 18)
- Frequency and Titer of Anti-drug Antibodies and Frequency of Neutralizing Antibodies Against AVT03 and Prolia(Month 18)
- Serum Trough Concentration of AVT03 and Prolia(Month 18)
- Percent Change From Baseline in LS BMD(Month 6, Month18)