JPRN-jRCT2080224911已完成3 期
A randomized, double-blind, multicenter integrated phase I/III study in postmenopausal women with osteoporosis to compare the pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity of GP2411 (proposed biosimilar denosumab) and Prolia (EU-authorized).
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sandoz Inc.
- 入组人数
- 46
研究概览
简要总结
Conclusion: In conclusion, the study showed that there are no clinically meaningful differences between GP2411 andEU-Prolia in the treatment of women with PMO over 78 weeks: • Clinical efficacy, PD and PK similarity were demonstrated. • Likewise, the immunogenicity, safety and tolerability comparison did not suggest any relevant differences between GP2411 and EU-Prolia. • The switch from the originator (EU-Prolia) to the proposed biosimilar GP2411 did not result in increased immunogenicity compared with continued EU-Prolia treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized at 1:1 ratio Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Masking Description: double blind Primary Purpose: Treatment
入排标准
- 年龄范围
- >= 18age old 至 <= 80age old（—）
- 性别
- Female
入选标准
- •Postmenopausal women, diagnosed with osteoporosis
- •-Aged >_ 55 and _< 80 years at screening
- •-Body weight >_ 50 kg and _< 90 kg at screening
- •-Absolute bone mineral density consistent with T-score _< -2.5 and >_ -4.0 at the lumbar spine as measured by DXA
- •-At least two vertebrae in the L1-L4 region and at least one hip joint are evaluable by DXA
排除标准
- •-Previous exposure to denosumab (Prolia, Xgeva, or biosimilar denosumab)
- •-History and/or presence of one severe or more than two moderate vertebral fractures or hip fracture
- •-History and/or presence of bone metastases, bone disease or metabolic disease
- •-Ongoing use of any osteoporosis treatment or use of prohibited treatment
- •-Other bone active drugs
- •-History and/or current hypoparathyroidism or hyperparathyroidism, hypocalcemia or hypercalcemia
- •Other Inclusion/exclusion criteria may apply
研究者
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