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To Evaluate the Efficacy and Safety of SAL056 for Postmenopausal Women With Osteoporosis at High Fracture Risk | Clinical Trials | Clareo Health

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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

NCT07028320•Shenzhen Salubris Pharmaceuticals Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

45 - 80 years

Sex

FEMALE

Healthy Volunteers

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

Locations (1)

Shanghai Sixth People's Hosptital

Shanghai, China

Key Dates

Start Date

December 3, 2021

Primary Completion Date

December 30, 2023

Completion Date

May 20, 2024

Last Updated

June 25, 2025

Enrollment

493

ACTUAL participants

Conditions

Postmenopausal Women With Osteoporosis

Interventions

SAL056 (56.5μg)

DRUG

Alendronate

DRUG

Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis

NCT01631214

Postmenopausal Women With Osteoporosis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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