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

NCT07028320 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 493

Last updated 2025-06-25

No results posted yet for this study

Summary

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

Conditions

  • Postmenopausal Women With Osteoporosis

Interventions

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

Sponsors & Collaborators

  • Shenzhen Salubris Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Zheng Lin Zhang · Shanghai 6th People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-12-03
Primary Completion
2023-12-30
Completion
2024-05-20

Countries

  • China

Study Locations

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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 NCT07028320 on ClinicalTrials.gov