drugset / Trial / NCT05638399
Denosumab vs Zoledronate After Lumbar Fusion
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Denosumab | Monoclonal antibody | 60 mg | Subcutaneous |
| Comparator | Zoledronate | Other / unclassified | 5 mg | Intravenous |