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A Phase 3 Study to Compare Biosimilar Denosumab With Prolia®

NCT05405725 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 504

Last updated 2026-02-10

Study results available
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Summary

The Study will be conducted to Compare the Efficacy, Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Enzene Denosumab (ENZ215) and Prolia® in Postmenopausal Women with Osteoporosis.

The primary goal for the study is

1. To evaluate the efficacy of ENZ215 when compared to Prolia® in patients with postmenopausal osteoporosis, in terms of change in BMD at the lumbar spine from baseline to Month 12 and
2. To compare the AUEC of sCTX levels from baseline to Month 6

Conditions

  • Postmenopausal Osteoporosis

Interventions

BIOLOGICAL

ENZ215

Enrolled women with postmenopausal osteoporosis receive ENZ215 (60mg)

BIOLOGICAL

Prolia

Enrolled women with postmenopausal osteoporosis receive Prolia

Sponsors & Collaborators

  • Alkem Laboratories Ltd

    collaborator INDUSTRY

  • Enzene Biosciences Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-04
Primary Completion
2024-07-18
Completion
2024-07-18

Countries

  • Bulgaria
  • Czechia
  • Denmark
  • Lithuania
  • Poland
  • Serbia
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05405725 on ClinicalTrials.gov