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A Comparative Study to Valuating the Efficacy and Safety of QL1206 and Prolia®

NCT07062978 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 278

Last updated 2025-07-14

No results posted yet for this study

Summary

This study is a multicenter, randomized, double-blind comparative study to valuating the efficacy and safety of QL1206 and Prolia® in postmenopausal women with osteoporosis at high risk of fracture.

Conditions

  • Postmenopausal Women With Osteoporosis at High Risk of Fracture

Interventions

DRUG

QL1206

QL1206 Denosumab injection(60 mg) was administered subcutaneously once every 6 months for a maximum of 2 consecutive doses throughout the trial.

DRUG

Prolia®

Prolia® Denosumab injection(60 mg) was administered subcutaneously once every 6 months for a maximum of 2 consecutive doses throughout the trial.

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

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
2025-06-27
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • China

Study Locations

More Related Trials

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 NCT07062978 on ClinicalTrials.gov