NCT07435051

Prospective, Randomized, Multicenter Clinical Trial of Bisphosphonates Combined With Vancomycin for the Treatment of Cierny-Mader Type I and III Osteomyelitis

Prospective, Randomized, Multicenter Clinical Trial of Bisphosphonates Bombined With Vancomycin for the Treatment of Cierny-Mader Type I and III Osteomyelitis

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy and Safety of Bisphosphonates Combined with Vancomycin in the Treatment of Refractory Osteomyelitis

Conditions

• Osteomyelitis (Refractory)

Interventions

Type	Name	Description
DRUG	Bisphosphonates Combined with Vancomycin	After undergoing debridement surgery for osteomyelitis. 1. Bisphosphonates: fasting oral alendronate 70mg/w for 24 weeks. 2. Vancomycin: intravenous infusion of 2 g/d, given twice with an interval of 12 hours, 1 g each time, treatment for 1 weeks, sequential oral linezolid for total 6 weeks, during which strict attention was paid to drug side effects.
DRUG	Vancomycin	After undergoing debridement surgery for osteomyelitis. 1. Placebo: fasting oral placebo 1 piece/w for 24 weeks. 2. Vancomycin: intravenous infusion of 2 g/d, given twice with an interval of 12 hours, 1 g each time, treatment for 1 weeks, sequential oral linezolid for total 6 weeks, during which strict attention was paid to drug side effects.

Timeline

• Start date: 2026-05-01
• Primary completion: 2029-12-31
• Completion: 2030-12-31
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: China