A Double-blind, Randomized, Multicenter, Multiple-dose, 2-arm, Parallel-group Study to Evaluate Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 - Proposed Biosimilar to Denosumab with Prolia® in Postmenopausal Women with Osteoporosis (LUMIADE-3 Study) - LUMIADE-3 Study

Fresenius Kabi SwissBioSim GmbH0 个研究点目标入组 556 人开始时间: 2021年3月15日最近更新: 2024年3月18日

适应症

试验速览

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•1. Female =55 to =85 years of age, inclusive, at screening.
•2. Subject should have confirmed postmenopausal status, defined as age-related or early/premature amenorrhea =12 consecutive months and increased follicle-stimulating hormone (FSH) >40 mIU/mL at screening; or surgical menopause (bilateral oophorectomy with or without hysterectomy) =12 months prior to screening.
•3. Absolute BMD consistent with T-score =-2.5 and =-4.0 at the lumbar spine as measured by DXA as per central assessment.
•4. At least 2 vertebrae in the L1-L4 region and at least 1 hip joint are evaluable by DXA.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 370
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 186

•1. History and/or presence of 1 severe or >2 moderate vertebral fractures or hip fracture confirmed by x-ray.
•2. Presence of active healing fracture at screening.
•3. History and/or presence of bone-related disorders, such as but not limited to Paget’s disease, osteomalacia, hyperparathyroidism (or parathyroid disorders), or renal osteodystrophy.
•4. Osteonecrosis of the jaw (ONJ) or risk factors for ONJ such as invasive dental procedures, poor oral hygiene,
•periodontal, and/or pre-existing dental disease as assessed by the Investigator.
•5. Prior denosumab (Prolia, Xgeva, or proposed denosumab biosimilar) exposure.
•6. Prior use of fluoride within the 5 years before inclusion in the study.
•7. Any current or prior use of strontium ranelate.

发起方