Attending Physician of Shenzhen People's Hospital

ShenzhenPH spine wang04

Bone mineral density and function at 1 year after screw fixation with denosumab vs zoledronic acid for osteoporotic vertebral compression fractures: a parallel double-blind randomized controlled clinical trial

2021-09-08

2023-03-05

2023-03-11

Recruiting

Early phase I

122

Inclusion Criteria: * Must be age between 40 and 90 years old * X-ray diagnosis of 1-2 vertebral compression fractures * Dual eneragy X ray test for bone mineral density T value less than -1 * fracture history lasted within 6 weeks * Must be MRI showed bone marrow edema of injured segment * Must be 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 calcium level ≤2.13 mmol/L * Must be able to have no previous use of anti-osteoporosis drugs * 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': 122, 'type': 'ESTIMATED'}}

2023-02-21