Denosumab vs Zoledronate After Lumbar Fusion

Sex: All

Ages: 40 Years – 85 Years

Phase: PHASE3

Enrollment: 100

Sponsor: Shenzhen People's Hospital

Summary

The aim of the study was to compare denosumab and zoledronate efficacy in bone mass, bone turnover markers (BTMs), Visual Analogue Scale (VAS) for leg and back, EuroQol Five-Dimension (EQ-5D) scores, Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 (QUALEFFO-31) scores, and Roland-Morris Disability Functioning Questionnaire (RMDQ) scores, secondary fracture, complications and adverse events after lumbar fusion.

Eligibility Criteria

Inclusion Criteria:Participants aged 40 to 85 yearswho diagnosed with lumbar spinal stenosis or lumbar spondylolisthesisosteopenia with BMD T score between -1.0 and -2.5 via dual-energy X-raylow back pain or leg numbness or weeknessMRI demonstrated signs of nerve compressionpatients with one or two level symptoms.Exclusion Criteria:cauda equina syndromeprogressive neurologic deficithistory of cancerscoliosis greater than 15°back open surgery historyhave contraindications for surgerywho had anti-osteoporosis medication within 6 weeks

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05638399). StuddyBuddy aggregates publicly available trial information.