NCT07062978

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 278 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: Female
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2025-06-27
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2025-07-14
• Last updated: 2025-07-14

Locations

1 site across 1 country: China