A Phase 3 interventional study of Bisphosphonates Combined with Vancomycin and Vancomycin in Osteomyelitis (Refractory), sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Phase 3, Interventional, and Treatment
A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy and Safety of Bisphosphonates Combined with Vancomycin in the Treatment of Refractory Osteomyelitis
Exclusion Criteria:
To evaluate the infection control effect of bisphosphonate combined with vancomycin in treatment of refractory osteomyelitis.
Drug: Bisphosphonates Combined with Vancomycin
Effect of vancomycin on infection control of refractory osteomyelitis.
Drug: 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.
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.
Infection control rate at 6 months
The primary outcome of this trial is the status of infection control within 6 months after treatment. Infection control is defined by meeting the following three criteria: (1) The patient's body temperature returns to normal, and the local wound heals well (no exudation or purulence, no redness, swelling, or pain). (2) Blood routine tests (white blood cell count, neutrophil ratio) and inflammatory markers (C-reactive protein (CRP), erythrocyte sedimentation rate (ESR)) show a progressive decrease until they return to normal levels. (3) X-ray imaging indicates the formation of new bone callus.
Time frame: 6 months
Infection control rate within 1 year
No clinical, biological, or radiological signs of infection (pain, fever); Or the same bacteria come back.
Time frame: 1 year
Plan to share: Undecided — Due to policy constraints, it was not clear whether information could be shared.
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Second Affiliated Hospital, School of Medicine, Zhejiang University