Trials / Completed
CompletedNCT05598606
Denosumab vs Zoledronate After Vertebroplasty
Denosumab vs Zoledronate in Patients With Osteoporotic Vertebral Compression Fracture After Percutaneous Vertebroplasty: A Randomized Controlled Trial
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- Shenzhen People's Hospital · Academic / Other
- Sex
- All
- Age
- 50 Years – 90 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Whether denosumab was non-inferior than zoledronate 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 zoledronate on BMD, BTMs, functional status, secondary fracture rate, and adverse events in OVCF patients after PVP during a 12-month follow-up period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Denosumab Injection | 1 ml (60 mg) of denosumab (Prolia; Amgen, Inc) subcutaneous injection plus intravenous placebo every 6 months (Q6M) |
| DRUG | Zoledronate | Intravenous zoledronic acid 5 mg plus subcutaneous placebo every 12 months |
Timeline
- Start date
- 2021-01-12
- Primary completion
- 2023-01-10
- Completion
- 2023-01-14
- First posted
- 2022-10-28
- Last updated
- 2023-01-18
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05598606. Inclusion in this directory is not an endorsement.