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

NCT07435051 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 2024-0319
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Osteomyelitis; Vancomycin; Bisphosphonates

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (1)

• Infection control rate within 1 year

  1 year

Study Arms (2)

Bisphosphonates Combined with Vancomycin

EXPERIMENTAL

To evaluate the infection control effect of bisphosphonate combined with vancomycin in treatment of refractory osteomyelitis.

Drug: Bisphosphonates Combined with Vancomycin

Vancomycin

ACTIVE COMPARATOR

Effect of vancomycin on infection control of refractory osteomyelitis.

Drug: Vancomycin

Interventions

Bisphosphonates Combined with Vancomycin DRUG

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.

Bisphosphonates Combined with Vancomycin

Vancomycin DRUG

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.

Vancomycin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with chronic osteomyelitis (Cierny-Mader type I and III) based on clinical manifestations (local pain, redness and swelling, sinus tract formation, etc.), laboratory findings (elevated white blood cell count, neutrophil ratio, CRP and ESR, positive pathogenic bacterial culture), and typical imaging features (X-ray, CT, MRI), and who require debridement surgery.
• Pathogen susceptibility testing confirms the causative organism as Staphylococcus aureus or methicillin-resistant Staphylococcus aureus (MRSA).
• Subjects aged 18 to 65 years.
• Male or female subjects.
• Written informed consent is obtained from the subject and their family members.
• The study protocol has been approved by the hospital ethics committee.
• Willing and able to comply with the study protocol, scheduled follow-up, and toxicity management as judged by the study investigators.

You may not qualify if:

• Known hypersensitivity or resistance to the components of the product (bisphosphonates, vancomycin)NCBI.
• Currently on long-term bisphosphonate therapy, or having received intravenous bisphosphonates within the past year.
• Patients with systemic infectious diseases (sepsis, bacteremia, or septicemia) or immunocompromised status (HIV/AIDS or receiving immunosuppressive medications).
• Patients with granulocytopenia (\< 1×10⁹/L).
• Patients with poorly controlled diabetes (HbA1c \> 8%).
• History of gastrointestinal bleeding or active hemoptysis (at least half a teaspoon of bright red blood) within 3 weeks prior to the first dose of study medication.
• Patients with unexplained hypocalcemia.
• Patients with renal impairment (serum creatinine \> 177 μmol/L or eGFR \< 50 mL/min).
• Females who are breastfeeding or pregnant at screening or baseline.
• Currently enrolled in another clinical trial, or having received any investigational drug or device within 30 days prior to providing informed consent.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

the Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Osteomyelitis

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Zhao Ming Ye, PhD

CONTACT

86-1360651549; yezhaominghz@163.com

Zeng Jie Zhang, PhD

CONTACT

zhangzengjie330@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: February 27, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

CN (1)