A Study to Evaluate the Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 in Postmenopausal Women With Osteoporosis

Exclusion Criteria

• •Disease-related
• •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 (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.
• •5. Evidence of hypocalcemia (albumin-adjusted serum calcium \<2.13 mmol/L or \<8.5 mg/dL) or hypercalcemia (albumin-adjusted serum calcium \>2.6 mmol/L or \>10.5 mg/dL) as assessed by the central laboratory at screening.
• •6. Vitamin D deficiency (25-hydroxy vitamin D levels \<12 ng/mL) as assessed by central laboratory at screening (retest is allowed once).
• •7. Known intolerance to calcium or vitamin D supplements.
• •Other Medical Conditions
• •8. Known or suspected clinically relevant drug hypersensitivity to any components of the study drug, comparable drugs, or to latex.
• •9. Renal impairment: creatinine clearance \<30 mL/min at screening or receiving dialysis.
• •10. Medical evidence of current or history of primary or secondary immunodeficiency.
• •11. Infection-related exclusions as further defined in the protocol.
• •12. Major surgical procedure within 8 weeks prior to the screening or scheduled during the study.
• •13. Current or history of any malignancy, or myeloproliferative, or lymphoproliferative disease within 5 years before screening.
• •14. History of clinically significant drug or alcohol abuse within the last year prior to randomization.
• •15. Prior denosumab (Prolia, Xgeva, or proposed denosumab biosimilar) exposure.
• •16. Prior use of fluoride within the 5 years before inclusion in the study.
• •17. Any current or prior use of strontium ranelate.
• •18. Any current or prior use of intravenous bisphosphonates.
• •19. Current or prior use of teriparatide and other parathormone (PTH) analogues within 12 months before screening.
• •20. Current or prior use of systemic oral or transdermal estrogen or selective estrogen receptor modulators or tibolone within 6 months before screening.
• •21. Current or prior use of calcitonin or cinacalcet within 3 months before screening or any cathepsin K inhibitor (eg, odanacatib) within 18 months before screening.
• •22. Current or prior use of romosozumab or antisclerostin antibody.
• •23. Current or prior use of other osteoporotic agents used for the prevention or treatment of osteoporosis.
• •24. Current use within 3 months before screening of any medication with known influence on the skeletal system (eg, systemic corticosteroids, heparin, lithium, etc) with exceptions described in the protocol.
• •25. Concomitant treatment with another biologic drug.
• •26. Have received a COVID-19 vaccine within 4 weeks before randomization or COVID-19 vaccination is ongoing at the time of screening.