DRUG
SAL056 (56.5μg)
Administered by subcutaneous injection once a week during treatment phase
Status
Completed
Phase
Phase 3
Enrollment
493
Locations
1
Results
Not posted
Publications
0
Study summary
To Evaluate the Efficacy and Safety of SAL056 for Postmenopausal Women with Osteoporosis at High Fracture Risk
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.
Interventions
DRUG
Administered by subcutaneous injection once a week during treatment phase
DRUG
70 mg tablet taken once a week during treatment phase
Timeline
First posted
Jun 19, 2025
Study start
Dec 3, 2021
Primary completion
Dec 30, 2023
Study completion
May 20, 2024
Results posted
Not reported
Registry updated
Jun 25, 2025
Outcomes
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine from Baseline to 48 Weeks
Time frame · Baseline to 48 Weeks
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine from Baseline to 48 Weeks
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine from Baseline to 24 Weeks
Time frame · 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
Time frame · 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
Time frame · 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
Time frame · Baseline to 24/48 Weeks
Proportion of Subjects With New Fragility Fractures from Baseline to 24/48 Weeks
Eligibility
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 locations
China. Showing up to 24 locations stored in the fast local snapshot.
Shanghai Sixth People's Hosptital
Shanghai, China
Publications
No PMID-linked publications were present in this registry snapshot.
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