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NCT05058443
Denosumab and Osteoporotic Vertebral Compression Fracture
Phase 2, PHASE3 trial testing Denosumab 60 mg/ml [Prolia] in Osteoporotic Vertebral Compression Fracture in 90 participants. Completed in 10 August 2022.
5 August 2022
Quick facts
| Lead sponsor | Shenzhen People's Hospital |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 90 |
| Start date | 6 January 2020 |
| Primary completion | 5 August 2022 |
| Estimated completion | 10 August 2022 |
| Sites | 1 location across China |
Drugs / interventions tested
- Denosumab 60 mg/ml [Prolia] — full drug profile →
- Placebo
Conditions studied
- Osteoporotic Vertebral Compression Fracture — all drugs for Osteoporotic Vertebral Compression Fracture →
Sponsor
Shenzhen People's Hospital
Who can join
Adults 50 to 90, any sex, with Osteoporotic Vertebral Compression Fracture. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study aimed to investigate the effect of denosumab on bone mineral density(BMD), bone turnover markers(BTMs), functional status, secondary fracture rate, and adverse effects in osteoporotic vertebral compression fracture (OVCF) patients after vertebroplasty during a 12-month follow-up period.
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 NCT05058443
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Shenzhen People's Hospital trials
Trials by the same sponsor.
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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 NCT05058443 (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 People's Hospital
- Last refreshed: 21 February 2023
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/NCT05058443.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing