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Clinical Efficacy and Safety Comparative Study Between CMAB807 Injection and Prolia® .

NCT04591275 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 278

Last updated 2025-02-20

No results posted yet for this study

Summary

evaluate the differences in effectiveness and safety between CMAB807( potential biosimilar) and Prolia(original product)

Conditions

  • Postmenopausal Osteoporosis

Interventions

DRUG

CMAB807 Injection

mAb targeting RANKL, human monoclonal antibody targeting RANKL

DRUG

Prolia®

mAb targeting RANKL, human monoclonal antibody targeting RANKL

Sponsors & Collaborators

  • Shanghai Biomabs Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • weibo Xia, Doctor · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-03-31
Primary Completion
2024-11-01
Completion
2024-11-01

Countries

  • China

Study Locations

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Entities

Drugs

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 NCT04591275 on ClinicalTrials.gov