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

February 25, 2026 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

280

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bisphosphonates Combined with Vancomycin
To evaluate the infection control effect of bisphosphonate combined with vancomycin in treatment of refractory osteomyelitis.
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.
Active Comparator: Vancomycin
Effect of vancomycin on infection control of refractory osteomyelitis.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infection control rate at 6 months
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infection control rate within 1 year
Time Frame: 1 year
No clinical, biological, or radiological signs of infection (pain, fever); Or the same bacteria come back.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

October 23, 2024

First Submitted That Met QC Criteria

February 25, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-0319

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Due to policy constraints, it was not clear whether information could be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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