Denosumab vs Zoledronate After Lumbar Fusion

• Status: Recruiting
• Trial end date: 2023-01-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shenzhen People's Hospital
• Treatments: Denosumab; Zoledronic Acid

Criteria

Inclusion Criteria:

• Participants aged 40 to 85 years

• who diagnosed with lumbar spinal stenosis or lumbar spondylolisthesis

• osteopenia with BMD T score between -1.0 and -2.5 or osteoporosis with T score lower than -2.5 via dual-energy X-ray

• low back pain or leg numbness or weekness

• MRI demonstrated signs of nerve compression

Exclusion Criteria:

• cauda equina syndrome

• progressive neurologic deficit

• history of cancer

• scoliosis greater than 15°

• back open surgery history

• have contraindications for surgery