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A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis

NCT04757376 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 479

Last updated 2024-06-14

Study results available
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Summary

This study is a Double-blind, Randomized, Active-controlled, Phase 3 Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety of CT-P41 and US-licensed Prolia in Postmenopausal Women with Osteoporosis

Conditions

  • Postmenopausal Women With Osteoporosis

Interventions

BIOLOGICAL

CT-P41

60 mg/mL single dose, Solution for injection in PFS

BIOLOGICAL

US-licensed Prolia

60 mg/mL single dose, Solution for injection in PFS

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-17
Primary Completion
2023-05-18
Completion
2023-11-16
FDA Drug
Yes

Countries

  • Estonia
  • Latvia
  • Poland
  • Ukraine

Study Locations

More Related Trials

Entities

Companies

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 NCT04757376 on ClinicalTrials.gov