Postmenopausal Women With OsteoporosisPhase 3NCT07028320
To Evaluate the Efficacy and Safety of SAL056 for Postmenopausal Women With Osteoporosis at High Fracture Risk
A Phase 3 study testing SAL056 (56.5μg) and Alendronate in people with Postmenopausal Women With Osteoporosis, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
To Evaluate the Efficacy and Safety of SAL056 for Postmenopausal Women with Osteoporosis at High Fracture Risk Read more about this study
- Who is it for?
- Ages 45 to 80 years, women only
- Conditions the study is for
- Postmenopausal Women With Osteoporosis
- What is being tested?
- SAL056 (56.5μg) and Alendronate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 493 participants
- Where
- 1 siteChina
- Study dates
- 3 Dec 2021to 20 May 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women with the ability to live independently (≥45 and ≤80 years);
- 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
Who cannot join
- In addition to postmenopausal osteoporosis, the other diseases affecting bone metabolism;
- Patients with other diseases affecting calcium or bone metabolism;
- Received anti-osteoporosis treatment that does not meet protocol requirements;
- 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;
- Patients requiring long-term or continuous use of digoxin and other digitalis drugs during the trial;
- Patients with other severe underlying diseases； Patients with abnormal indicators that does not meet protocol requirements during the screening periodlaboratory tests
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Postmenopausal Women With Osteoporosis
- Being tested
- SAL056 (56.5μg), Alendronate
- Keywords
- Postmenopausal Women With Osteoporosis; Teriparatide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAL056 (56.5μg)Drug
Also called Teriparatide for Injection
Administered by subcutaneous injection once a week during treatment phase
AlendronateDrug
70 mg tablet taken once a week during treatment phase
| Study group | Role | What they receive |
|---|---|---|
| Drug: SAL056 (56.5μg) | Experimental | Administered by subcutaneous injection once a week during treatment phase Receives: Drug: SAL056 (56.5μg) |
| Drug: Alendronate | Active comparator | 70 mg tablet taken once a week during treatment phase Receives: Drug: Alendronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to 48 Weeks
Secondary outcomes (4)
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
Measured: Baseline to 24 Weeks
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
Measured: Baseline to 24/48 Weeks
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
Measured: Baseline to 12/24/48 Weeks
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
Measured: Baseline to 24/48 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start3 Dec 2021
- Primary completion30 Dec 2023
- Study completion20 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal Women With OsteoporosisStudies of the same condition, open and under way.
- More trials run by Shenzhen Salubris Pharmaceuticals Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 493 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zheng Lin Zhang, Principal investigator, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028320
- Sponsor's protocol ID
- SAL056A301
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07028320
- Acronym / sponsor ID
- SAL056A301
- Conditions
- Postmenopausal Women With Osteoporosis
- Keywords
- Postmenopausal Women With Osteoporosis; Teriparatide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 493 participants (actual)
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Dec 2021 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 20 May 2024 (actual)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug: SAL056 (56.5μg) | Experimental | Drug: SAL056 (56.5μg)Administered by subcutaneous injection once a week during treatment phase |
| Drug: Alendronate | Active comparator | Drug: Alendronate70 mg tablet taken once a week during treatment phase |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Postmenopausal women with the ability to live independently (≥45 and ≤80 years);
- 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
Key exclusion criteria (6 listed)
- In addition to postmenopausal osteoporosis, the other diseases affecting bone metabolism;
- Patients with other diseases affecting calcium or bone metabolism;
- Received anti-osteoporosis treatment that does not meet protocol requirements;
- 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;
- Patients requiring long-term or continuous use of digoxin and other digitalis drugs during the trial;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAL056 (56.5μg)Also: Teriparatide for InjectionAdministered by subcutaneous injection once a week during treatment phase | Drug | Drug: SAL056 (56.5μg) |
| Alendronate70 mg tablet taken once a week during treatment phase | Drug | Drug: Alendronate |
Primary outcome
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
4 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 Total Hip from Baseline to 24/48 Weeks
Time frame: 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
Proportion of Subjects with New Fragility Fractures from Baseline to 24/48 Week
Time frame: Baseline to 24/48 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zheng Lin Zhang principal investigator
Shanghai 6th People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SAL056 (56.5μg) and Alendronate in people with Postmenopausal Women With Osteoporosis, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine from Baseline to 48 Weeks (time frame: Baseline to 48 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.