Attending Doctor of Shenzhen People's Hospital

ShenzhenPH spine wang02

Evaluation of bone mineral density and function at 1 year after screw internal fixation of osteoporotic vertebral compression fractures with desuzumab: a parallel double-blind randomized controlled clinical trial

2021-09-14

2023-03-20

2023-09-25

Withdrawn

Early phase I

Inclusion Criteria:• Must be age between 40 and 90 years old * X-ray diagnosis of 1-2 vertebral compression fractures * Dual energy X ray test bone mineral density T value less than -1 * fracture history lasted within 6 weeks * MRI showed bone marrow edema of injured segment * lower back pain, local spines tenderness Exclusion Criteria: * • Must be able to have no posterior vertebral wall fracture * Must be able to have no patients with intervertebral fissure * Must be able to have no infection * Must be able to have no malignancy * Must be able to have no neurological dysfunction * Must be able to have no previous use of anti-osteoporosis drugs within 6 weeks * Must be able to have no inability to perform magnetic resonance imaging * Must be able to have no prior back surgery * Must be able to have no other established contraindications for elective surgery

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

2023-03-14