This is a randomised, double-blind, multicentre study to evaluate the efficacy, safety, PK, PD, and immunogenicity of SB16 compared to Prolia® in postmenopausal women with osteoporosis.
Subjects will be randomised in a 1:1 ratio to receive either SB16 or Prolia®. At Month 12, subjects in Prolia® treatment group will be randomised again in a 1:1 ratio to either continue on Prolia® treatment or be transitioned to SB16 treatment. Investigational product (60 mg in 1 mL of SB16 or Prolia®) will be given subcutaneously every 6 months up to Month 12, and the last assessment will be done at Month 18.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
457
Subjects randomised into SB16 group will receive SB16 (60 mg in 1 mL) subcutaneously every 6 months. At Month 12, subjects transited from Prolia® group to SB16 group will receive SB16 (60 mg in 1 mL) subcutaneously.
Subjects randomised into Prolia® group will receive Prolia® (60 mg in 1 mL) subcutaneously every 6 months.
SB Investigative Site
Krakow, Poland
SB Investigative Site
Lodz, Poland
SB Investigative Site
Siedlce, Poland
SB Investigative Site
Warsaw, Poland
SB Investigative Site
Zamość, Poland
Percent Change From Baseline in Lumbar Spine BMD at Month 12
Time frame: Baseline and Month 12
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