Denosumab Biosimilar (Suzhou Alphamab)

Main study objective: In postmenopausal women with osteoporosis, evaluate the change rate of lumbar spine (L1-L4) bone mineral density (BMD) from baseline to month 12 in subjects treated with KN012 and Prolia®. Secondary study objectives: In postmenopausal women with osteoporosis, to evaluate the change rate of lumbar spine (L1-L4) BMD from baseline to month 6 in the two treatment groups; to evaluate the change rate of hip, femoral neck, trochanter, and forearm BMD from baseline to month 6 and month 12 in the two treatment groups; to evaluate the change rate of serum type I collagen cross-linked C-terminal peptide (s-CTX) and serum type I procollagen N-terminal propeptide (s-PINP) from baseline to month 1, 3, 6, 9, and 12; to evaluate the effective rate of bone mineral density change and the incidence of fractures; to evaluate the safety of the two treatment groups, including immunogenicity; to conduct population pharmacokinetic (PopPK) analysis to evaluate the PK similarity between KN012 and Prolia®.