Effects of Denosumab on Bone Fusion in Osteoporotic Patients After Lumbar Fusion
Status:
Recruiting
Trial end date:
2023-10-01
Target enrollment:
Participant gender:
Summary
Lumbar fusion is an accepted and effective technique for the treatment of lumbar degenerative
disease. As the population ages, disability associated with spinal pathology and spinal
surgery is rapidly increasing and there is a concomitant increase in prevalence of
osteoporosis which is a detrimental factor for Lumbar fusion and instrumentation.
Osteoporosis-related bone fragility is a primary reason for spinal fusion failure, implant
fixation failure, and vertebral compression fractures above or below the fusion sites.
Denosumab is a human monoclonal antibody against RANKL, it inhibits osteoclast mediated bone
destruction and has been found to be effective in treating osteoporosis, including reducing
bone turnover markers, increasing bone mineral density (BMD), and reducing fractures. But few
studies focus on the effects of Denosumab on lumbar fusion. In this study, we include
osteoporotic patients with lumbar degenerative disease who have had lumbar interbody fusion
surgery. The patients were randomized to either treatment of Denosumab or no treatment. All
these patients are followed at 3, 6, 9, 12 months postoperation. During these periods, we
detect bone metabolism and bone fusion of these patients. Finally, we would report whether
Denosumab can improve bone metabolism and promote bone fusion or not.