Efficacy and safety of the biosimilar denosumab candidate (Arylia) compared to the reference product (Prolia®) in postmenopausal osteoporosis: a phase III, randomized, two-armed, double-blind, parallel, active-controlled, and noninferiority clinical trial.
Jamshidi A, Vojdanian M, Soroush M, Akbarian M, Aghaei M, Hajiabbasi A, Mirfeizi Z, Khabbazi A, Alishiri G, Haghighi A, Salimzadeh A, Karimzadeh H, Shirani F, Fard MRH, Nazarinia M, Soroosh S, Anjidani N, Gharibdoost F.
Jamshidi A, et al.
Arthritis Res Ther. 2022 Jun 30;24(1):161. doi: 10.1186/s13075-022-02840-8.
Arthritis Res Ther. 2022.
PMID: 35773713
Free PMC article.
Clinical Trial.
The primary endpoint was the noninferiority of the biosimilar product to the reference product in the percentage change of bone mineral density (BMD) in 18 months at the lumbar spine (L(1)-L(4)), total hip, and femoral neck. The secondary endpoints were safety asses …
The primary endpoint was the noninferiority of the biosimilar product to the reference product in the percentage change of bone mineral dens …