NCT04729621已完成3 期
A Randomized, Double-Blind, Multinational, Multicenter Study to Compare Efficacy, Safety, and Immunogenicity of TVB-009P and Denosumab (Prolia®) in Patients With Postmenopausal Osteoporosis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 332
- 试验地点
- 115
- 主要终点
- Percent Change From Baseline in LS-BMD at Week 52
研究概览
简要总结
The purpose of this study is to demonstrate similar efficacy and safety between TVB-009 and Prolia® (denosumab)
详细描述
This is a multinational, multicenter, randomized, double-blind study to demonstrate similar efficacy and safety of TVB-009 compared to Prolia® administered subcutaneously at doses of 60 mg every 26 weeks. Approximately 326 postmenopausal women with osteoporosis will be randomized to receive either TVB-009 or Prolia®. At week 52, patients in the Prolia® arm will be re-randomized 1:1 to either continue with a third dose of Prolia® or transition to TVB-009 and receive a single dose of TVB-009 in the transition period to assess immunogenicity and safety after a transition from Prolia® to TVB-009. The total treatment duration for each patient is 78 weeks.
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
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal womeen (≥60 and ≤90 years) with a diagnosis of osteoporosis
- •Body weight ≥50 kg and ≤90 kg
- •Bone Mineral Density (BMD) measurement T score of less than -2.5 but not less than -4.0 by dual-energy X-ray absorptiometry (DXA) at the lumbar spine at screening
- •At least 3 vertebrae in the L1 L4 region that are evaluable by dual-energy X-ray absorptiometry (DXA)
排除标准
- •One severe or more than two moderate vertebral fractures
- •History and/or presence of hip fracture or atypical femur fracture
- •Any prior treatment with denosumab
- •Ongoing use of any bone active drugs which can affect Bone Mineral Density (BMD)
- •Vitamin D deficiency or hyper- or hypocalcemiacium at screening
- •Hyperthyroidism, hypothyroidism, hypoparathyroidism or hyperparathyroidism
- •Any medical condition that could jeopardize or would compromise the patient's safety or ability to participate in this study
- •Other Inclusion/exclusion criteria may apply
结局指标
主要结局
Percent Change From Baseline in LS-BMD at Week 52
时间窗: Baseline and week 52
Percent change from baseline in lumbar spine bone mineral density (LS BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 52
次要结局
- Percent Change From Baseline in sCTX-1 at Week 26(Baseline and week 26)
- Percent Change From Baseline in LS-BMD at Week 26(Baseline and week 26)
- Percent Change From Baseline in Femoral Neck BMD at Week 26(Baseline, week 26)
- Percent Change From Baseline in sCTX-1(Baseline through Week 52)
- Percent Change From Baseline in Total Hip BMD at Week 26(Baseline, week 26)
- Percent Change From Baseline in P1NP(Baseline through Week 52)
- Percent Change From Week 52 in LS-BMD by DXA at Week 78(Week 52 through week 78)
- Percent Change From Week 52 in Femoral Neck BMD by DXA at Week 78(Week 52 through week 78)
- Percent Change From Week 52 in Total Hip BMD by DXA at Week 78(Week 52 through week 78)
- Percentage of Participatns With sCTX-1 Suppression at Week 4(Week 4)
- Incidence of Antidrug Antibodies (ADAs) in the Transition Period(Anytime in Week 52 through Week 78)
- Percent Change From Baseline in Femoral Neck BMD at Week 52(Baseline through Week 52)
- Number of Fractures up to Week 52(Up to week 52)
- Incidence of Adverse Events in the Transition Period(Week 52 through week 78)
- Percent Change From Baseline in Total Hip BMD at Week 52(Baseline through Week 52)
- Number of TEAEs Leading to Patient Withdraw From the Study(Main Treatment Period = Baseline-Week 52; Transition period = Week 52-78)
- Local Tolerability at Injection Site(Main Treatment Period = Day 1 & Week 26; Transition Treatment Period = Week 52)
- Difference Between Percent Change From Baseline in sCTX-1 Between Week 52 and Week 78(Baseline, Week 52, Week 78)
- Difference Between Percent Change From Baseline in P1NP Between Week 52 and Week 78(Baseline, Week 52, Week 78)
- Number of Patients With Fractures Between Week 52 and Week 78(Week 52 through week 78)
- Incidence of Adverse Event(Up to week 52)
- Incidence of Antidrug Antibodies (ADAs) in the Main Treatment Period(Anytime Post Baseline through Week 52)
研究者
研究点 (115)
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