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

Phase 3

Completed

• Conditions: Postmenopausal Women With Osteoporosis
• Interventions: Drug: SAL056 (56.5μg); Drug: Alendronate

• Registration Number: NCT07028320
• Lead Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd.

Brief 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.

Study Timeline

• Study Start: 2021-12-03
• Primary Completion: 2023-12-30
• Study Completion: 2024-05-20
• Status Verified: 2025-06
• Study First Submitted: 2025-06-11
• Study First Submitted QC: 2025-06-11
• Study First Posted: 2025-06-19
• Last Update Submitted: 2025-06-19
• Last Update Posted: 2025-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 493

Inclusion Criteria

1. Postmenopausal women with the ability to live independently (≥45 and ≤80 years);
2. The patient has a body mass index(BMI) of 18.0 kg/m2 to 30 kg/m2； The patient has one of the following diagnostic criteria for osteoporosis and subject has at least 2 consecutive vertebrae region (L1 to L4) that are evaluable by dual-energy x-ray absorptiometry (DXA)，a) History of hip/vertebra fragility fracture and bone mineral density (BMD) T-score ≤-1; b）the axial bone (lumbar , femoral neck or total hip) mineral density (BMD) T-score ≤-2.50;c) Bone mineral density (BMD) T-score ≥-2.5 and ≤-1 with proximal humerus, pelvis, or distal forearm end fragility fracture

Exclusion Criteria

1. In addition to postmenopausal osteoporosis, the other diseases affecting bone metabolism;
2. Patients with other diseases affecting calcium or bone metabolism;
3. Received anti-osteoporosis treatment that does not meet protocol requirements;
4. Received medication that affects bone metabolism prior to screening, or is planned to use prohibited drugs/non-drug therapy under the protocol during the study period;
5. Patients requiring long-term or continuous use of digoxin and other digitalis drugs during the trial;
6. Patients with other severe underlying diseases； Patients with abnormal indicators that does not meet protocol requirements during the screening periodlaboratory tests

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug: SAL056 (56.5μg)	SAL056 (56.5μg)	Administered by subcutaneous injection once a week during treatment phase
Drug: Alendronate	Alendronate	70 mg tablet taken once a week during treatment phase

Primary Outcome Measures

Name	Time	Method
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine from Baseline to 48 Weeks	Baseline to 48 Weeks	Percent Change in Bone Mineral Density (BMD) of Lumbar Spine from Baseline to 48 Weeks

Secondary Outcome Measures

Name	Time	Method
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine from Baseline to 24 Weeks	Baseline to 24 Weeks	Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 24 Weeks
Percent Change in Bone Mineral Density (BMD) of Total Hip from Baseline to 24/48 Weeks	Baseline to 24/48 Weeks	Percent Change in Bone Mineral Density (BMD) of Total Hip From Baseline to 24/48 Weeks
Percent Change in S-CTX and P1NP From Baseline to12/ 24/48 Weeks	Baseline to 12/24/48 Weeks	Percent Change in S-CTX and P1NP From Baseline to 12/24/48 Weeks
Proportion of Subjects with New Fragility Fractures from Baseline to 24/48 Week	Baseline to 24/48 Weeks	Proportion of Subjects With New Fragility Fractures from Baseline to 24/48 Weeks

Trial Locations

Locations (1)

Shanghai Sixth People's Hosptital; 🇨🇳 Shanghai, China