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NOT YET RECRUITING
NCT07435051
PHASE3

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

Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

Summary

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

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

280

Start Date

2026-05-01

Completion Date

2030-12-31

Last Updated

2026-02-27

Healthy Volunteers

No

Interventions

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.

Locations (1)

the Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China