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CompletedNCT07028320Updated Jun 25, 2025

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

A Phase 3 interventional study of SAL056 (56.5μg) and Alendronate in Postmenopausal Women With Osteoporosis, sponsored by Shenzhen Salubris Pharmaceuticals Co., Ltd.. Completed at 1 site in China. Open to female participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-06-25.

Sponsored by Shenzhen Salubris Pharmaceuticals Co., Ltd. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 6 months after the study started (first participant enrolled Dec 2021, registered Jun 2025).
Phase
Phase 3
Study type
Interventional
Enrollment
493
Allocation
Randomized
Ages
45 Years to 80 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Postmenopausal Women With Osteoporosis

Keywords

  • Postmenopausal Women With Osteoporosis; Teriparatide
03

In context

Lead sponsor

Shenzhen Salubris Pharmaceuticals Co., Ltd. is the lead sponsor of 39 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 80 Years
Sexes eligible
Female
Accepts 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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
493 participants (actual)

Study arms

  • Experimental
    Drug: SAL056 (56.5μg)

    Administered by subcutaneous injection once a week during treatment phase

    Drug: SAL056 (56.5μg)

  • Active comparator
    Drug: Alendronate

    70 mg tablet taken once a week during treatment phase

    Drug: Alendronate

Interventions

  • DrugSAL056 (56.5μg)

    Administered by subcutaneous injection once a week during treatment phase

    Also known as: Teriparatide for Injection

  • DrugAlendronate

    70 mg tablet taken once a week during treatment phase

06

What researchers measure

Primary outcomes

  1. 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 48 Weeks

    Time frame: Baseline to 48 Weeks

Secondary outcomes

  1. Percent Change in Bone Mineral Density (BMD) of Lumbar Spine from Baseline to 24 Weeks

    Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 24 Weeks

    Time frame: Baseline to 24 Weeks

  2. Percent Change in Bone Mineral Density (BMD) of Total Hip from Baseline to 24/48 Weeks

    Percent Change in Bone Mineral Density (BMD) of Total Hip From Baseline to 24/48 Weeks

    Time frame: Baseline to 24/48 Weeks

  3. Percent Change in S-CTX and P1NP From Baseline to12/ 24/48 Weeks

    Percent Change in S-CTX and P1NP From Baseline to 12/24/48 Weeks

    Time frame: Baseline to 12/24/48 Weeks

  4. Proportion of Subjects with New Fragility Fractures from Baseline to 24/48 Week

    Proportion of Subjects With New Fragility Fractures from Baseline to 24/48 Weeks

    Time frame: Baseline to 24/48 Weeks

07

Study locations

1 site
  • Shanghai Sixth People's Hosptital
    Shanghai, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07028320
Lead sponsor
Shenzhen Salubris Pharmaceuticals Co., Ltd.
Responsible party
Sponsor
First posted
Jun 19, 2025
Start date
Dec 3, 2021
Primary completion
Dec 30, 2023
Completion
May 20, 2024
Last update
Jun 25, 2025

Study contacts

Zheng Lin Zhang
principal investigator · Shanghai 6th People's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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