NCT05662358

Denosumab vs Alendronate After Vertebroplasty

Denosumab vs Alendronate in Patients With Osteoporotic Vertebral Compression Fracture After Percutaneous Vertebroplasty: A Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Shenzhen People's Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Osteoporotic vertebral compression fracture (OVCF) patients had a proportion of secondary fractures after percutaneous vertebroplasty (PVP). Denosumab and alendronate 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 alendronate for OVCF patients bone mineral density (BMD), bone turnover markers (BTMs), secondary fracture and adverse events after PVP

Detailed description

Whether denosumab was non-inferior than alendronate in improving bone mineral density (BMD), bone turnover markers (BTMs), functional status questionnaires, and secondary fracture in elderly patients with OVCF after PVP remains unknown. A prospective, randomized, placebo-controlled clinical trial in OVCF patients with PVP was performed. This study aimed to investigate the efficiency of denosumab vs alendronate on BMD, BTMs, functional status, secondary fracture rate, and adverse events in OVCF patients after PVP during a 12-month follow-up period.

Conditions

• Denosumab Allergy

Interventions

Type	Name	Description
DRUG	Denosumab	1 ml (60 mg) of denosumab (Prolia; Amgen, Inc) subcutaneous injection
DRUG	Alendronate	oral 70 mg alendronate sodium weekly plus subcutaneous placebo per 6 month.
DRUG	Placebo	oral placebo weekly

Timeline

• Start date: 2021-01-03
• Primary completion: 2023-09-20
• Completion: 2023-10-25
• First posted: 2022-12-22
• Last updated: 2023-02-21

Locations

1 site across 1 country: China