drugset / Trial / NCT05598606
Denosumab vs Zoledronate After Vertebroplasty
RandomizedParallel-groupTriple-blindTreatment
Summary
Osteoporotic vertebral compression fracture (OVCF) patients had a proportion of secondary fractures after percutaneous vertebroplasty (PVP). Denosumab and zoledronate acid is both effective to prevent bone loss for OVCF postmenopausal women. However, trial evidence comparing effect of denosumab vs zoledronate after PVP was unknown. The study aims to assess the efficiency of denosumab vs zoledronate for OVCF patients bone mineral density (BMD), bone turnover markers (BTMs), secondary fracture and adverse events after PVP.
Timeline
- Start
- 2021-01-12
- Primary completion
- 2023-01-10
- Completion
- 2023-01-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Denosumab | Monoclonal antibody | 60 mg | Subcutaneous |
| Comparator | Zoledronic acid | Other / unclassified | 5 mg | Intravenous |