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NCT07028320
To Evaluate the Efficacy and Safety of SAL056 for Postmenopausal Women With Osteoporosis at High Fracture Risk
Phase 3 trial testing SAL056 (56.5μg) in Postmenopausal Women With Osteoporosis in 493 participants. Completed in 20 May 2024.
30 December 2023
Quick facts
| Lead sponsor | Shenzhen Salubris Pharmaceuticals Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 493 |
| Start date | 3 December 2021 |
| Primary completion | 30 December 2023 |
| Estimated completion | 20 May 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- SAL056 (56.5μg) — full drug profile →
- Alendronate — full drug profile →
Conditions studied
- Postmenopausal Women With Osteoporosis — all drugs for Postmenopausal Women With Osteoporosis →
Sponsor
Shenzhen Salubris Pharmaceuticals Co., Ltd. — full company profile →
Who can join
Adults 45 to 80, female only, with Postmenopausal Women With Osteoporosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To Evaluate the Efficacy and Safety of SAL056 for Postmenopausal Women with Osteoporosis at High Fracture Risk
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Efficacy of once-weekly teriparatide versus alendronate in Chinese postmenopausal osteoporosis: a randomised, open-label, active-controlled, 48-week, multicentre phase III study.
Gu J, Chao A, Huo Y, Zhang Y, et al · · 2026 · PMID 42182073 · DOI 10.1016/j.jot.2026.101101
Verify or expand the search:
- PubMed search for NCT07028320
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Shenzhen Salubris Pharmaceuticals Co., Ltd. trials
Trials by the same sponsor.
- NCT07486453 — Bioequivalence Study of Sacubitril Alisartan Amlodipine Tablets · Phase 1 · not yet recruiting
- NCT07384104 — Compare the Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of SAL023 and Italy-Manufactured Evenity in He · Phase 1 · enrolling by invitation
- NCT07174830 — Pharmacokinetic Study of Allisartan Isoproxil Tablets in Healthy Chinese Participants · Phase 4 · recruiting
- NCT06737081 — SAL-0951 in the Treatment of Chemotherapy-induced Anemia in Patients With Non-myeloid Malignancies · Phase 2 · recruiting
- NCT07253584 — A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Safety and Efficacy · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07028320 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shenzhen Salubris Pharmaceuticals Co., Ltd.
- Last refreshed: 25 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07028320.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing