drugset / Trial / NCT05638399

Denosumab vs Zoledronate After Lumbar Fusion

NCT05638399

Phase 3 Unknown 100 enrolled Shenzhen People's Hospital
RandomizedParallel-groupDouble-blindTreatment

Summary

The aim of the study was to compare denosumab and zoledronate efficacy in bone mass, bone turnover markers (BTMs), Visual Analogue Scale (VAS) for leg and back, EuroQol Five-Dimension (EQ-5D) scores, Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 (QUALEFFO-31) scores, and Roland-Morris Disability Functioning Questionnaire (RMDQ) scores, secondary fracture, complications and adverse events after lumbar fusion.

Timeline

Start
2020-01-15
Primary completion
2023-02-26
Completion
2023-02-28

Drugs

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

Indications