Current partner codePEPTIDESDE
NCT07028320·Phase 3·INTERVENTIONAL

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

Status

Completed

Phase

Phase 3

Enrollment

493

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Full 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.

Interventions

Treatment arms and agents.

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

Timeline

From registration to results.

  1. First posted

    Jun 19, 2025

  2. Study start

    Dec 3, 2021

  3. Primary completion

    Dec 30, 2023

  4. Study completion

    May 20, 2024

  5. Results posted

    Not reported

  6. Registry updated

    Jun 25, 2025

Outcomes

What the study measures.

Primary 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

Secondary outcomes

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

Who can take part.

Minimum age
45 Years
Maximum age
80 Years
Sex
FEMALE
Healthy volunteers
No

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

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Shanghai Sixth People's Hosptital

Shanghai, China

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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Put the record in context.

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