Current or prior use of systemic oral or transdermal estrogen or selective estrogen receptor modulators or tibolone within 6 months before screening.Current or prior use of teriparatide and other parathormone (PTH) analogues within 12 months before screening.Any current or prior use of intravenous bisphosphonates.Any current or prior use of strontium ranelate.Prior use of fluoride within the 5 years before inclusion in the study. Prior denosumab (Prolia, Xgeva, or proposed denosumab biosimilar) exposure.History of clinically significant drug or alcohol abuse within the last year prior to randomization.Current or history of any malignancy, or myeloproliferative, or lymphoproliferative disease within 5 years before screening.Major surgical procedure within 8 weeks prior to the screening or scheduled during the study.Infection-related exclusions as further defined in the protocol.Medical evidence of current or history of primary or secondary immunodeficiency.Renal impairment: creatinine clearance Known or suspected clinically relevant drug hypersensitivity to any components of the study drug, comparable drugs, or to latex.Known intolerance to calcium or vitamin D supplements. Vitamin D deficiency (25-hydroxy vitamin D levels Evidence of hypocalcemia (albumin-adjusted serum calcium 2.6 mmol/L or >10.5 mg/dL) as assessed by the central laboratory at screening.Osteonecrosis of the jaw (ONJ) or risk factors for ONJ such as invasive dental procedures (eg, tooth extraction, dental implants, or oral surgery in the past 6 months), poor oral hygiene, periodontal, and/or pre-existing dental disease as assessed by the Investigator.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.Presence of active healing fracture at screening.History and/or presence of 1 severe or >2 moderate vertebral fractures or hip fracture confirmed by x-ray.Written informed consent including accepting a separate Information Sheet containing important information about COVID-19 and its general risks for participants participating in the clinical trial.Clinically acceptable physical examinations and laboratory tests and no history or evidence of any clinically significant concomitant medical disorder that, in the opinion of the Investigator, would pose a risk to participant safety or interfere with study evaluations or procedures.At least 2 vertebrae in the lumbar vertebrae 1 to lumbar vertebrae 4 (L1-L4) region and at least 1 hip joint are evaluable by DXA.Absolute bone mineral density (BMD) consistent with T-score ≤-2.5 and ≥-4.0 at the lumbar spine as measured by dual energy x-ray absorptiometry (DXA) as per central assessment.Participant 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. Have a body mass index (BMI) ≥18 to ≤32 kg/m^2.Female ≥55 to ≤85 years of age, inclusive, at screening.Participants who were randomized to receive FKS518 at the beginning of the Double-blind Core Treatment Period will continue to receive this treatment during the Double-blind Transition Period.įor Marketing Authorization Application (MAA) in the EU and European Economic Area (EEA) only: The primary objective is to demonstrate equivalent efficacy and pharmacodynamics of the proposed biosimilar denosumab FKS518 to US-Prolia in women with PMO. Participants will be randomized at the beginning of the Double-blind Core Treatment Period (Baseline to Week 52) to receive either FKS518 or US-licensed Prolia on Day 1, and then every 26 weeks for up to 52 weeks.Īt the beginning of the Double-blind Transition Period (Week 52 to Week 78), participants who received US-licensed Prolia will be re-randomized to either continue receiving US-licensed Prolia every 26 weeks for up to 78 weeks, or switch to receive FKS518 every 26 weeks for up to 78 weeks. The primary objective of this study is to demonstrate equivalent efficacy of FKS518 to US-licensed Prolia in women with postmenopausal osteoporosis (PMO).
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