NCT04757376已完成3 期
A Double-blind, Randomized, Active-controlled, Phase 3 Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety of CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Celltrion
- 入组人数
- 479
- 试验地点
- 39
- 主要终点
- Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52 - Full Analysis Set (FAS)
研究概览
简要总结
This study is a Double-blind, Randomized, Active-controlled, Phase 3 Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety of CT-P41 and US-licensed Prolia in Postmenopausal Women with Osteoporosis
详细描述
This is a double-blind, randomized, active-controlled, Phase 3 study to evaluate the efficacy, PK, PD, and safety including immunogenicity of CT-P41 compared with US-licensed Prolia in postmenopausal women with osteoporosis. All patients will also receive daily supplementation containing at least 1,000 mg of elemental calcium and at least 400 IU vitamin D from randomization to EOS visit and the data will be collected via patient's diary.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women, 50 to 80 years of age, both inclusive.
- •Body weight between 40.0 and 99.9 kg, both inclusive, when rounded to the nearest tenth.
- •Postmenopausal
- •Bone mineral density T-score ≤ - 2.5 and ≥ - 4.0 at the lumbar spine (L1 to L4) as assessed by the central imaging vendor based on dual-energy X-ray absorptiometry(DXA) scan.
- •Patients must have at least 3 vertebrae considered evaluable at the lumbar spine (L1 to L4) and at least 1 hip considered evaluable by DXA scan assessed by the central imaging vendor. Patients with unilateral metal in hips that would be allowed for the other side of 1 evaluable hip are included.
- •Patient with albumin-adjusted total serum calcium ≥ 8.5 mg/dL (≥ 2.125 mmol/L) at Screening.
排除标准
- •Patient previously received denosumab, any other monoclonal antibodies, or biologic agents for osteoporosis
- •Patient confirmed or suspected with infection of COVID-19 at Screening, or has contact with COVID-19 patient within 14 days from Screening
- •Patient with history and/or presence of one severe or > 2 moderate vertebral fractures as determined by central reading of lateral spine X-ray
- •Patient with history and/or presence of hip fracture
- •Patient with history and/or presence of hyperparathyroidism or hypoparathyroidism, irrespective of current controlled or uncontrolled status
- •Patient with current hyperthyroidism (unless well controlled on stable antithyroid therapy)
- •Patient with current hypothyroidism (unless well controlled on stable thyroid replacement therapy)
- •Patient with history and/or presence of bone disease and metabolic disease (except for osteoporosis) that may interfere with the interpretation of the results
结局指标
主要结局
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52 - Full Analysis Set (FAS)
时间窗: baseline (screening), Week 52 predose
Bone mineral density was assessed by dual-energy X-ray absorptiometry (DXA) and assessments of the lumbar spine (L1 to L4) were performed at a central imaging vendor. To evaluate the difference between 2 groups in the primary efficacy endpoint, the percent change from baseline in BMD for lumbar spine (L1 to L4) by DXA at Week 52 was analyzed using an analysis of covariance (ANCOVA) model coupled with multiple imputation assuming the data to be missing at random (MAR).
次要结局
- Incidence of New Vertebral, Nonvertebral, and Hip Fractures During TP I - FAS(up to Week 52 predose)
- Percent Change From Baseline for Serum Concentration of Procollagen Type 1 N-terminal Propeptide (P1NP) at Weeks 26 and 52 - PD Set(Baseline (Week 0 Day 1 predose), Weeks 26 and 52 (predose))
- Ctrough of Denosumab at Week 52 - PK-TP II Subset(Week 52)
- Percent Change From Baseline in Lumbar Spine, Total Hip, and Femoral Neck BMD at Week 52 - FAS(baseline (screening), Week 52 predose)
- Trough Serum Concentration (Ctrough) of Denosumab at Weeks 0 and 26 - Pharmacokinetic (PK) Set(Week 0 Day 1 predose, Week 26 predose)
- Maximum Serum Concentration (Cmax) of Denosumab After First Dose - PK Set(from baseline (Week 0 Day 1 predose) to Week 26 predose)
- Percent Change From Baseline for Serum Concentration of Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) at Weeks 26 and 52 - Pharmacodynamic (PD) Set(Baseline (Week 0 Day 1 predose), Weeks 26 and 52 (predose))
- Percent Change From Baseline in Lumbar Spine, Total Hip, and Femoral Neck BMD at Week 78 - FAS-TP II Subset(baseline (screening), Week 78)
- Incidence of New Vertebral, Nonvertebral, and Hip Fractures During TP II - FAS-TP II Subset(from Week 52 to Week 78)
- Percent Change From Baseline for Serum Concentration of s-CTX at Week 78 - PD-TP II Subset(Baseline (Week 0 Day 1 predose), Week 78)
- Percent Change From Baseline for Serum Concentration of P1NP at Week 78 - PD-TP II Subset(Baseline (Week 0 Day 1 predose), Week 78)
- Number of Participants With at Least 1 ADA/NAb Result After the First Study Drug Administration of TP II - Safety-TP II Subset(from Week 52 to Week 78)
- Number of Participants With at Least 1 Anti-drug Antibodies (ADA)/Neutralizing Antibodies (NAb) Result After the First Study Drug Administration of TP I - Safety Set(up to Week 52 predose)
研究者
研究点 (39)
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