Denosumab Biosimilar Injection in Post Menopausal Women With Osteoporosis

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05419427
Study type	Interventional
Source	Lambda Therapeutic Research Ltd.
Contact	Mr Prashant Modi
Phone	917940202375
Email	prashantmodi@lambda-cro.com
Status	Recruiting
Phase	Phase 3
Start date	November 11, 2021
Completion date	November 24, 2024

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