Denosumab vs Zoledronate After Vertebroplasty

• Status: Recruiting
• Trial end date: 2022-11-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Must be age between 50 and 90 years old

• X-ray diagnosis of 1 or 2 segment vertebral compression fractures from T4 to L5

• Bone mineral density T value less than -1 via dual-energy X-ray

• A recent fracture history less than 6 weeks

• MRI show bone marrow edema of fractured vertebrae

• low back pain, local paravertebral tenderness

Exclusion Criteria:

• Must be able to have no intervertebral fissure

• Must be able to have no infection

• Must be able to have no malignancy

• Must be able to have no neurological dysfunction

• Must be able to have no previous use of anti-osteoporosis drugs

• Must be able to have no inability to perform magnetic resonance imaging

• Must be able to have no prior back open surgery

• Must be able to have no other established contraindications for elective surgery