drugset / Trial / NCT05598606

Denosumab vs Zoledronate After Vertebroplasty

NCT05598606

Phase 4 Completed 75 enrolled Shenzhen People's Hospital
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

EvaluationDrugModalityDoseRoute
Subject Denosumab Monoclonal antibody 60 mg Subcutaneous
Comparator Zoledronic acid Other / unclassified 5 mg Intravenous

Indications