Denosumab and Screw Fixation for Osteoporotic Compression Fracture
NCT ID: NCT05065164
Last Updated: 2023-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2/PHASE3
INTERVENTIONAL
2021-09-14
2023-09-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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dnosumab
Desuzumab 60 mg subcutaneously /6 months, twice a year
Denosumab Only Product
denosumab subcutaneous injection /6 months, twice a year
placebo control
Placebo subcutaneous injection /6 months, twice a year
Denosumab Only Product
denosumab subcutaneous injection /6 months, twice a year
Interventions
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Denosumab Only Product
denosumab subcutaneous injection /6 months, twice a year
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
40 Years
90 Years
ALL
Yes
Sponsors
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Shenzhen People's Hospital
OTHER
Responsible Party
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Principal Investigators
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Hongyu Wang, Doctor
Role: PRINCIPAL_INVESTIGATOR
Shenzhen People's Hospital
Locations
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ShenzhenPH
Shenzhen, Guangdong, China
Countries
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Other Identifiers
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ShenzhenPH spine wang02
Identifier Type: -
Identifier Source: org_study_id
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