Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-04-06 @ 12:24 PM
Study NCT ID:
NCT07435051
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2024-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective, Randomized, Multicenter Clinical Trial of Bisphosphonates Combined With Vancomycin for the Treatment of Cierny-Mader Type I and III Osteomyelitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010019', 'term': 'Osteomyelitis'}], 'ancestors': [{'id': 'D001850', 'term': 'Bone Diseases, Infectious'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014640', 'term': 'Vancomycin'}], 'ancestors': [{'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 280}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-25', 'studyFirstSubmitDate': '2024-10-23', 'studyFirstSubmitQcDate': '2026-02-25', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infection control rate at 6 months', 'timeFrame': '6 months', 'description': "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).\n\n(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."}], 'secondaryOutcomes': [{'measure': 'Infection control rate within 1 year', 'timeFrame': '1 year', 'description': 'No clinical, biological, or radiological signs of infection (pain, fever); Or the same bacteria come back.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Osteomyelitis', 'Vancomycin', 'Bisphosphonates'], 'conditions': ['Osteomyelitis (Refractory)']}, 'descriptionModule': {'briefSummary': 'A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy and Safety of Bisphosphonates Combined with Vancomycin in the Treatment of Refractory Osteomyelitis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* Pathogen susceptibility testing confirms the causative organism as Staphylococcus aureus or methicillin-resistant Staphylococcus aureus (MRSA).\n* Subjects aged 18 to 65 years.\n* Male or female subjects.\n* Written informed consent is obtained from the subject and their family members.\n* The study protocol has been approved by the hospital ethics committee.\n* Willing and able to comply with the study protocol, scheduled follow-up, and toxicity management as judged by the study investigators.\n\nExclusion Criteria:\n\n* Known hypersensitivity or resistance to the components of the product (bisphosphonates, vancomycin)NCBI.\n* Currently on long-term bisphosphonate therapy, or having received intravenous bisphosphonates within the past year.\n* Patients with systemic infectious diseases (sepsis, bacteremia, or septicemia) or immunocompromised status (HIV/AIDS or receiving immunosuppressive medications).\n* Patients with granulocytopenia (\\< 1×10⁹/L).\n* Patients with poorly controlled diabetes (HbA1c \\> 8%).\n* 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.\n* Patients with unexplained hypocalcemia.\n* Patients with renal impairment (serum creatinine \\> 177 μmol/L or eGFR \\< 50 mL/min).\n* Females who are breastfeeding or pregnant at screening or baseline.\n* Currently enrolled in another clinical trial, or having received any investigational drug or device within 30 days prior to providing informed consent.'}, 'identificationModule': {'nctId': 'NCT07435051', 'briefTitle': 'Prospective, Randomized, Multicenter Clinical Trial of Bisphosphonates Combined With Vancomycin for the Treatment of Cierny-Mader Type I and III Osteomyelitis', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Prospective, Randomized, Multicenter Clinical Trial of Bisphosphonates Bombined With Vancomycin for the Treatment of Cierny-Mader Type I and III Osteomyelitis', 'orgStudyIdInfo': {'id': '2024-0319'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bisphosphonates Combined with Vancomycin', 'description': 'To evaluate the infection control effect of bisphosphonate combined with vancomycin in treatment of refractory osteomyelitis.', 'interventionNames': ['Drug: Bisphosphonates Combined with Vancomycin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vancomycin', 'description': 'Effect of vancomycin on infection control of refractory osteomyelitis.', 'interventionNames': ['Drug: Vancomycin']}], 'interventions': [{'name': 'Bisphosphonates Combined with Vancomycin', 'type': 'DRUG', 'description': 'After undergoing debridement surgery for osteomyelitis.\n\n1. Bisphosphonates: fasting oral alendronate 70mg/w for 24 weeks.\n2. 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.', 'armGroupLabels': ['Bisphosphonates Combined with Vancomycin']}, {'name': 'Vancomycin', 'type': 'DRUG', 'description': 'After undergoing debridement surgery for osteomyelitis.\n\n1. Placebo: fasting oral placebo 1 piece/w for 24 weeks.\n2. 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.', 'armGroupLabels': ['Vancomycin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'Zhao Ming Ye, PhD', 'role': 'CONTACT', 'email': 'yezhaominghz@163.com', 'phone': '8613606501549'}], 'facility': 'the Second Affiliated Hospital of Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Zhao Ming Ye, PhD', 'role': 'CONTACT', 'email': 'yezhaominghz@163.com', 'phone': '86-1360651549'}, {'name': 'Zeng Jie Zhang, PhD', 'role': 'CONTACT', 'email': 'zhangzengjie330@163.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Due to policy constraints, it was not clear whether information could be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}