NCT05203588

Effects of Denosumab on Bone Fusion in Osteoporotic Patients After Lumbar Fusion

The Effects of Denosumab on Bone Fusion and Bone Metabolism in Osteoporotic Patients With Lumbar Degenerative Disease After Lumbar Interbody Fusion

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: Shanghai Changzheng Hospital · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoporosis
• Fusion of Spine, Lumbar Region

Interventions

Type	Name	Description
DRUG	Denosumab 60 mg/ml Injectable Solution [Prolia]	Denosumab, 60mg(1ml), subcutaneously, totally two times, with one time at 1-week postoperatively and another time at 26-week postoperatively.
DRUG	calcium and vitamin D	calcium (≥1·0 g) and vitamin D (≥400 IU).

Timeline

• Start date: 2021-10-09
• Primary completion: 2022-10-01
• Completion: 2023-10-01
• First posted: 2022-01-24
• Last updated: 2022-01-24

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study