drugset / Trial / NCT05911477

Recombinant Human Bone Morphogenetic Protein-2(rhBMP-2) in Patients With Osteoporosis After Lumbar Fusion

NCT05911477

Unknown 76 enrolled Xijing Hospital
RandomizedParallel-groupDouble-blindTreatment

Summary

rhBMP-2 has been used to promote spinal fusion. Despite potential risk of complications, satisfied results could be obtained with low dose of rhBMP-2. Effect of early bone formation has been validated using rat ovariectomy osteoporosis model. However, whether it functioned in patients with osteoporosis remained unknown. In this study, the investigators intend to investigate whether rhBMP-2 promotes early bone formation in patients with osteoporosis after transforaminal lumbar interbody fusion (TLIF).

Timeline

Start
2023-07-01
Primary completion
2023-12-31
Completion
2024-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject rhBMP-2 Protein / enzyme biologic 1 mg

Indications