NCT07028320

To Evaluate the Efficacy and Safety of SAL056 for Postmenopausal Women With Osteoporosis at High Fracture Risk

A Multicenter, Randomized, Open-label, Parallel Controlled, Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety of SAL056 (Teriparatide for Injection ) in the Treatment of Postmenopausal Women With Osteoporosis at High Fracture Risk

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 493 (actual)
• Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd. · Industry
• Sex: Female
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To Evaluate the Efficacy and Safety of SAL056 for Postmenopausal Women with Osteoporosis at High Fracture Risk

Detailed description

The trial consists of a screening period (4 weeks), an open-label treatment period (up to 48 weeks), and a follow-up period (1 weeks), totaling approximately 53 weeks. Subjects who withdraw early will be asked to complete an end of treatment visit, and a safety follow-up visit 2 weeks after the end of treatment visit.

Conditions

• Postmenopausal Women With Osteoporosis

Interventions

Type	Name	Description
DRUG	SAL056 (56.5μg)	Administered by subcutaneous injection once a week during treatment phase
DRUG	Alendronate	70 mg tablet taken once a week during treatment phase

Timeline

• Start date: 2021-12-03
• Primary completion: 2023-12-30
• Completion: 2024-05-20
• First posted: 2025-06-19
• Last updated: 2025-06-25

Locations

1 site across 1 country: China