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NCT06079476
A Study of Romosozumab (EVENITY®) in Postmenopausal Women in India With Osteoporosis at a High Risk of Fracture.
Phase 4 trial testing Romosozumab in Postmenopausal Osteoporosis in 100 participants. Completed in 18 October 2025.
18 October 2025
Quick facts
| Lead sponsor | Amgen |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 30 October 2023 |
| Primary completion | 18 October 2025 |
| Estimated completion | 18 October 2025 |
| Sites | 10 locations across India |
Drugs / interventions tested
- Romosozumab (romosozumab) — full drug profile →
Conditions studied
- Postmenopausal Osteoporosis — all drugs for Postmenopausal Osteoporosis →
Sponsor
Amgen — full company profile →
Who can join
18 and older, female only, with Postmenopausal Osteoporosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The primary objective of this study is to characterize safety and tolerability of romosozumab in postmenopausal women with osteoporosis and a high risk of fracture in India.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Bone-derived factors mediate crosstalk between skeletal and extra-skeletal organs.
He T, Qin L, Chen S, Huo S, et al · · 2025 · cited 20× · PMID 40307216 · DOI 10.1038/s41413-025-00424-1
Verify or expand the search:
- PubMed search for NCT06079476
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Romosozumab
Trials testing the same drug.
- NCT07283887 — Romosozumab and Denosumab, Alone or Combined, in Postmenopausal Osteoporosis · Phase 4 · recruiting
- NCT07384104 — Compare the Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of SAL023 and Italy-Manufactured Evenity in He · Phase 1 · enrolling by invitation
- NCT06558188 — Combined Anabolic Therapy · Phase 4 · recruiting
- NCT05972551 — Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Oste · Phase 3 · recruiting
- NCT05010590 — Anabolic Therapy in Postmenopausal Osteoporosis · Phase 4 · active not recruiting
Other recruiting trials for Postmenopausal Osteoporosis
Currently open trials in the same condition.
- NCT05010590 — Anabolic Therapy in Postmenopausal Osteoporosis · Phase 4 · active not recruiting
- NCT02822378 — Dried Plums and Bone Health in Postmenopausal Women · NA · active not recruiting
Other Amgen trials
Trials by the same sponsor.
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- NCT06987539 — A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Gen · Phase 2 · recruiting
- NCT05909761 — Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregn · recruiting
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 NCT06079476 (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 Amgen
- Last refreshed: 3 November 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/NCT06079476.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing