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
NA
90 participants
INTERVENTIONAL
2021-01-03
2023-10-25
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
DOUBLE
Study Groups
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Denosumab
1 ml (60 mg) of denosumab (Prolia; Amgen, Inc) subcutaneous injection plus intravenous placebo every 6 months
Denosumab
1 ml (60 mg) of denosumab (Prolia; Amgen, Inc) subcutaneous injection
Placebo
oral placebo weekly
alendronate
oral 70 mg alendronate sodium weekly.
Alendronate
oral 70 mg alendronate sodium weekly plus subcutaneous placebo per 6 month.
Placebo
oral placebo weekly
Interventions
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Denosumab
1 ml (60 mg) of denosumab (Prolia; Amgen, Inc) subcutaneous injection
Alendronate
oral 70 mg alendronate sodium weekly plus subcutaneous placebo per 6 month.
Placebo
oral placebo weekly
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* X-ray diagnosis of 1 or 2 segment vertebral compression fractures from T4 to L5
* Bone mineral density T value less than -1 via dual-energy X-ray
* A recent fracture history less than 6 weeks
* MRI show bone marrow edema of fractured vertebrae
* low back pain, local paravertebral tenderness
Exclusion Criteria
* 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
* Must be able to have no inability to perform magnetic resonance imaging
* Must be able to have no prior back open surgery
* Must be able to have no other established contraindications for elective surgery
50 Years
85 Years
ALL
No
Sponsors
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Shenzhen People's Hospital
OTHER
Responsible Party
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Locations
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Shenzhen People's Hospital
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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ShenzhenPH06
Identifier Type: -
Identifier Source: org_study_id
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