drugset / Trial / NCT05662358
Denosumab vs Alendronate After Vertebroplasty
RandomizedParallel-groupDouble-blindTreatment
Summary
Osteoporotic vertebral compression fracture (OVCF) patients had a proportion of secondary fractures after percutaneous vertebroplasty (PVP). Denosumab and alendronate 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 alendronate for OVCF patients bone mineral density (BMD), bone turnover markers (BTMs), secondary fracture and adverse events after PVP
Timeline
- Start
- 2021-01-03
- Primary completion
- 2023-09-20
- Completion
- 2023-10-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Alendronic Acid | Small molecule | 70 mg | Oral |
| Subject | Denosumab | Monoclonal antibody | 60 mg | Subcutaneous |