This study demonstrated the noninferiority of the biosimilar denosumab (Arylia) to the reference product in osteoporotic postmenopausal women. In general, there was no difference in the lumbar spine, total hip, or femoral neck BMD percentage change, the trend of bone metabolism biomarkers, or the occurrence of new vertebral fractures between the biosimilar denosumab and the reference product.
95% CI: 95% Confidence interval; AE: Adverse event; AESI: Adverse event of special interest; AFF: Atypical femoral fracture; BMD: Bone mineral density; BSAP: Bone-specific alkaline phosphatase; BTM: Bone turnover markers; CKD: Chronic kidney disease; CTCAE: Common Terminology Criteria for Adverse Events; CTX: C-terminal telopeptide; DXA: Dual-energy X-ray absorptiometry; FDA: Food and Drug Administration; FRAX: Fracture Risk Assessment Tool; GFR: Glomerular filtration rate; IOF: International Osteoporosis Foundation; ITT: Intention to treat; MedDRA: Medical Dictionary for Regulatory Activities; NTX: N-terminal telopeptide; OC: Osteocalcin; ONJ: Osteonecrosis of the jaw; P1NP: Procollagen type 1 N-terminal pro-peptide; PP: Per-protocol; RANK: Nuclear factor kappa-B; RANKL: Nuclear factor kappa-B ligand; SAE: Serious adverse events; SD: Standard deviation; SOC: System organ class; WHO: World Health Organization.
This study was funded by AryoGen Pharmed Company.
Availability of data and materials
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
Ethics approval and consent to participate
This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the ethics committees of Tehran University of Medical Sciences (No. IR.TUMS.VCR.REC.1395.1588) and Tabriz University of Medical Sciences (No. IR.TBZMED.REC.1395.758). Written informed consent was obtained from each individual participant involved in the study.
Consent for publication
Arthritis Res Ther. 2022;24(161) © 2022 BioMed Central, Ltd.
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