Denosumab of Intas is biosimilar denosumab candidate under development by Intas Pharmaceutical Limited (Biopharma Division). Denosumab of Intas is already approved by Indian drug licensing authority- Drug Controller General (India) for marketing in Indian population since 2018.As per regulatory requirement, a comparative clinical study to establish Pharmacokinetic, Pharmacodynamic and Immunogenicity equivalence is required to conclude therapeutic equivalence to obtain marketing authorization of a biosimilar investigational product. This is a multicenter, randomized, double-blind, active controlled study in approximately 552postmenopausal women with osteoporosis. An extension of the study is planned after completion of the initial 1 year of treatment. This extension is with the objective of submitting data on safety, and Immunogenicity, after switching of Prolia treatment arm to either Prolia or Intas denosumab for 6 months. This switching data is applicable only for FDA submission. Only patients who have undergone PK assessment will be eligible for the extension phase.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
552
Denosumab 60 MG/ML
Denosumab 60 MG/ML
S. R. Kalla Memorial Gastro & General Hospital
Jaipur, Rajasthan, India
RECRUITINGMaximum measured concentration after first dose of denosumab and denosumab-ref., ,
Time frame: Day 1 to Day 181
Area under the concentration versus time curve from time zero to the last measurable concentration as calculated by linear trapezoidal method between denosumab and denosumab-ref postmenopausal women with osteoporosis
Time frame: Day 1 to Day 181
Area under the concentration versus time curve from time zero to infinity. Where AUC 0-∞= AUC0-t + Ct2, Ct is the last measurable concentration and t2 is the terminal rate constant
Time frame: Day 1 to Day 181
Maximum percent reduction from baseline Emax percent reduction from baseline serum C-terminal telopeptide (CTX) after first dose of denosumab and denosumab-ref*
Time frame: Day 1 to Day 181
Area under the percent reduction from baseline versus time curve from time zero to the last measurable concentration as calculated by linear trapezoidal method
Time frame: Day 1 to Day 181
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