Osteomyelitis (Refractory)Phase 3NCT07435051
Prospective, Randomized, Multicenter Clinical Trial of Bisphosphonates Combined With Vancomycin for the Treatment of Cierny-Mader Type I and III Osteomyelitis
A Phase 3 study testing Bisphosphonates Combined with Vancomycin and Vancomycin in people with Osteomyelitis (Refractory), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy and Safety of Bisphosphonates Combined with Vancomycin in the Treatment of Refractory Osteomyelitis Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Osteomyelitis (Refractory)
- What is being tested?
- Bisphosphonates Combined with Vancomycin and Vancomycin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 31 Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zeng Jie Zhang, PhD contact
China1 site
the Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Zhao Ming Ye, PhD, 8613606501549, yezhaominghz@163.com
About this study
Official title: 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
- Conditions
- Osteomyelitis (Refractory)
- Being tested
- Bisphosphonates Combined with Vancomycin, Vancomycin
- Keywords
- Osteomyelitis, Vancomycin, Bisphosphonates
- Medical subject headings
- Osteomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bisphosphonates Combined with VancomycinDrug
After undergoing debridement surgery for osteomyelitis.
- Bisphosphonates: fasting oral alendronate 70mg/w for 24 weeks.
- 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.
VancomycinDrug
After undergoing debridement surgery for osteomyelitis.
- Placebo: fasting oral placebo 1 piece/w for 24 weeks.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Bisphosphonates Combined with Vancomycin | Experimental | To evaluate the infection control effect of bisphosphonate combined with vancomycin in treatment of refractory osteomyelitis. Receives: Drug: Bisphosphonates Combined with Vancomycin |
| Vancomycin | Active comparator | Effect of vancomycin on infection control of refractory osteomyelitis. Receives: Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Infection control rate within 1 year
No clinical, biological, or radiological signs of infection (pain, fever); Or the same bacteria come back.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteomyelitis (Refractory)Studies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435051
- Sponsor's protocol ID
- 2024-0319
- Status last verified
- Feb 2026
- First submitted
- 23 Oct 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Due to policy constraints, it was not clear whether information could be shared.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Multicenter Clinical Trial of Bisphosphonates Bombined With Vancomycin for the Treatment of Cierny-Mader Type I and III Osteomyelitis
- ClinicalTrials.gov ID
- NCT07435051
- Acronym / sponsor ID
- 2024-0319
- Conditions
- Osteomyelitis (Refractory)
- Keywords
- Osteomyelitis, Vancomycin, Bisphosphonates
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy and Safety of Bisphosphonates Combined with Vancomycin in the Treatment of Refractory Osteomyelitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bisphosphonates Combined with Vancomycin | Experimental | Drug: Bisphosphonates Combined with VancomycinTo evaluate the infection control effect of bisphosphonate combined with vancomycin in treatment of refractory osteomyelitis. |
| Vancomycin | Active comparator | Drug: VancomycinEffect of vancomycin on infection control of refractory osteomyelitis. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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%).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bisphosphonates Combined with VancomycinAfter 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 | Bisphosphonates Combined with Vancomycin |
| VancomycinAfter 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. | Drug | Vancomycin |
Primary outcome
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.
1 secondary outcome
Infection control rate within 1 year
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Undecided. Due to policy constraints, it was not clear whether information could be shared.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zeng Jie Zhang, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bisphosphonates Combined with Vancomycin and Vancomycin in people with Osteomyelitis (Refractory), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhao Ming Ye, PhD (86-1360651549, yezhaominghz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infection control rate at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.