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Recruiting
NCT05662358
Denosumab vs Alendronate After Vertebroplasty
Conditions: Denosumab Allergy
Sex: All
Ages: 50 Years – 85 Years
Phase: NA
Enrollment: 90
Sponsor: Shenzhen People's Hospital
Location: China
Summary
Osteoporotic vertebral compression fracture (OVCF) patients had a proportion of secondary fractures after percutaneous vertebroplasty (PVP).
Denosumab and alendronate is both effective to prevent bone loss for OVCF postmenopausal women.
However, trial evidence comparing effect of denosumab vs zoledronate after PVP was unknown.
The study aims to assess the efficiency of denosumab vs alendronate for OVCF patients bone mineral density (BMD), bone turnover markers (BTMs), secondary fracture and adverse events after PVP
Eligibility Criteria
Inclusion Criteria:Must be age between 50 and 85 years oldX-ray diagnosis of 1 or 2 segment vertebral compression fractures from T4 to L5Bone mineral density T value less than -1 via dual-energy X-rayA recent fracture history less than 6 weeksMRI show bone marrow edema of fractured vertebraelow back pain, local paravertebral tendernessExclusion Criteria:Must be able to have no intervertebral fissureMust be able to have no infectionMust be able to have no malignancyMust be able to have no neurological dysfunctionMust be able to have no previous use of anti-osteoporosis drugsMust be able to have no inability to perform magnetic resonance imagingMust be able to have no prior back open surgeryMust be able to have no other established contraindications for elective surgery
Source: ClinicalTrials.gov (NCT05662358). StuddyBuddy aggregates publicly available trial information.