Completed PHASE3 INTERVENTIONAL 2-arm NCT05405725

A Phase 3 Study to Compare Biosimilar Denosumab With Prolia®

A Randomized, Double-blind, Parallel-group, Active-controlled Study to Compare the Efficacy, Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Enzene Denosumab (ENZ215) and Prolia® in Postmenopausal Women With Osteoporosis

Sponsor: Alkem Laboratories Ltd

Conditions Postmenopausal Osteoporosis

Interventions ENZ215 Prolia

Updated 5 times since 2022 Last updated: Jan 22, 2026 Started: Jul 4, 2022 Primary completion: Jul 18, 2024 Completion: Jul 18, 2024

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Postmenopausal Osteoporosis, this trial is completed. The trial is conducted by Alkem Laboratories Ltd and has accumulated 5 data snapshots since 2022. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

5 versions recorded

Feb 2026 — Present [monthly]

Completed PHASE3

Status: Unknown → Completed
Sep 2024 — Feb 2026 [monthly]

Unknown PHASE3

Status: Recruiting → Unknown
Jul 2024 — Sep 2024 [monthly]

Recruiting PHASE3
Sep 2022 — Jul 2024 [monthly]

Recruiting PHASE3

Status: Not Yet Recruiting → Recruiting
Jul 2022 — Sep 2022 [monthly]

Not Yet Recruiting PHASE3

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Alkem Laboratories Ltd
Enzene Biosciences Ltd.

Data source: Enzene Biosciences Ltd.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Barcelona, Spain , Belgrade, Serbia , Bialystok, Poland , Brno, Czechia , Bydgoszcz, Poland , Częstochowa, Poland , Esbjerg, Denmark , Gdansk, Poland , Gdynia, Poland , Horní Město, Czechia and 24 more locations