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).

Sandoz Inc.1 个研究点目标入组 44 人开始时间: 待定最近更新: 2022年11月11日

适应症

试验速览

暂无简介。

研究类型: Interventional
干预模型: Allocation: Randomized at 1:1 ratio Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Masking Description: double blind Primary Purpose: Treatment
主要目的: Treatment Purpose

•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

•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

发起方

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