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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UNKNOWN
PHASE3
100 participants
INTERVENTIONAL
2020-01-15
2023-02-28
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
DOUBLE
Study Groups
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Denosumab
denosumab (60 mg subcutaneously, per 6 month)
Denosumab 60 mg/ml [Prolia]
60 mg subcutaneously per 6 month
zoledronate
zoledronate (5mg, intravenous infusion once a year)
Zoledronate
5mg, intravenous infusion once a year
Interventions
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Denosumab 60 mg/ml [Prolia]
60 mg subcutaneously per 6 month
Zoledronate
5mg, intravenous infusion once a year
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* who diagnosed with lumbar spinal stenosis or lumbar spondylolisthesis
* osteopenia with BMD T score between -1 and -2.5 via dual energy X-ray
* low back pain or leg numbness or weakness
* MRI demonstrated signs of nerve compression
* patients with one or two level symptoms.
Exclusion Criteria
* progressive neurologic deficit
* history of cancer
* scoliosis greater than 15°
* back open surgery history
* have contraindications for surgery
* who had anti-osteoporosis medication within 6 weeks
40 Years
85 Years
ALL
No
Sponsors
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Shenzhen People's Hospital
OTHER
Responsible Party
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Principal Investigators
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Songlin Peng, Doctor
Role: STUDY_CHAIR
Shenzhen People's Hospital
Locations
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ShenzhenPH
Shenzhen, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ShenzhenPH spine06
Identifier Type: -
Identifier Source: org_study_id
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