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

NCT ID: NCT07028320

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 493 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-03
• Study Completion Date: 2024-05-20

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.

Conditions

Postmenopausal Women With Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Drug: SAL056 (56.5μg)

Administered by subcutaneous injection once a week during treatment phase

Group Type: EXPERIMENTAL

SAL056 (56.5μg)

Intervention Type: DRUG

Administered by subcutaneous injection once a week during treatment phase

Drug: Alendronate

70 mg tablet taken once a week during treatment phase

Group Type: ACTIVE_COMPARATOR

Alendronate

Intervention Type: DRUG

70 mg tablet taken once a week during treatment phase

Interventions

SAL056 (56.5μg)

Administered by subcutaneous injection once a week during treatment phase

Intervention Type: DRUG

Alendronate

70 mg tablet taken once a week during treatment phase

Intervention Type: DRUG

Other Intervention Names

Teriparatide for Injection

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen Salubris Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zheng Lin Zhang

Role: PRINCIPAL_INVESTIGATOR

Shanghai 6th People's Hospital

Locations

Shanghai Sixth People's Hosptital

Shanghai, , China

Countries

China

Other Identifiers

SAL056A301

Identifier Type: -

Identifier Source: org_study_id