NCT05638399

Denosumab vs Zoledronate After Lumbar Fusion

Denosumab vs Zoledronate Efficacy in Osteopenic Patients With Lumbar Degenerative Disease After Lumbar Fusion Surgery

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Shenzhen People's Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Lumbar degenerative disease including spinal stenosis and lumbar spondylolisthesis were the most common reason lead to older patients disability, which was the main indication for older patients to perform lumbar fusion surgery. For patients with lumbar degenerative disease older than 50 years old, a proportion of patients had osteoporosis. The trial aims to investigate whether denosumab versus zoledronate acid in osteopenic patients with lumbar fusion surgery.

Conditions

• Osteopenia
• Lumbar Spondylolisthesis

Interventions

Type	Name	Description
DRUG	Denosumab 60 mg/ml [Prolia]	60 mg subcutaneously per 6 month
DRUG	Zoledronate	5mg, intravenous infusion once a year

Timeline

• Start date: 2020-01-15
• Primary completion: 2023-02-26
• Completion: 2023-02-28
• First posted: 2022-12-06
• Last updated: 2023-02-21

Locations

1 site across 1 country: China