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A Randomized,Double Blind,Active Controlled Parallel Arm Multicenter Study Comparing Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Denosumab of Intas Pharmaceutical Limited (60 mg/mL) With Prolia in Postmenopausal Women With Osteoporosis

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Trial Profile

A Randomized,Double Blind,Active Controlled Parallel Arm Multicenter Study Comparing Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Denosumab of Intas Pharmaceutical Limited (60 mg/mL) With Prolia in Postmenopausal Women With Osteoporosis

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 08 Dec 2025

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At a glance

  • Drugs Denosumab (Primary)
  • Indications Postmenopausal osteoporosis
  • Focus Pharmacokinetics

Most Recent Events

  • 20 Nov 2025 According to Accord pharmaceuticals, the U.S. FDA granted the approval of OSVYRTI (denosumab-desu), a biosimilar to Prolia (denosumab), and JUBEREQ (denosumab-desu), a biosimilar to Xgeva (denosumab) based on the data from this and phase I (CTRI2020-09-027619) trials.
  • 20 Nov 2025 Primary endpoint has been met. (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)
  • 20 Nov 2025 Primary endpoint has been met. (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)

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