Local treatment of osteoporotic sheep vertebral body with calcium sulfate for decreasing the potential fracture risk: Microstructural and biomechanical evaluations

Study Design: In this study, calcium sulfate (CS) was injected through pedicle into the osteoporotic vertebral body in vivo in sheep, and micro-computed tomography analysis, histologic observation, and biomechanical test were performed. Objective: To investigate the improvement on microstructure and biomechanical performance of lumbar vertebrae augmented with CS in osteoporotic sheep. Summary of Background Data: The present treatments for osteoporosis relies on systemic medications intended to increase the bone mineral density (BMD). Although effective, these timeconsuming medications provide little protection from fracture in the "early period" after initiation of therapy. In this regard, the strategy of local treatment is to target specific areas of the skeletal system that are prone to osteoporotic fractures. However, there is little or no research focused on local treatment of osteoporotic vertebrae with CS. Methods: Eight female sheep were induced to osteoporosis with bilateral ovariectomy and methylprednisolone administration for 12 months. After successful establishment of an osteoporotic model, lumbar vertebrae (L1-L4) in every sheep were randomly divided into 2 groups: CS group and control group (2 vertebrae in each group in every sheep). CS was injected into the vertebral body transpedicularly in the CS group and no treatments were performed in the control group. Three months later, all sheep were killed and all L1-L4 vertebrae were harvested. Thereafter, microstructure and biomechanical performance of the cancellous bone of the vertebral body were assessed through micro- computed tomography analysis, histologic observation, and biomechanical test, respectively. Results: After a 12-month induction with ovariectomy and methylprednisolone administration, the mean BMD of the sheep lumbar vertebrae significantly decreased (>25%) compared with the value before induction, which demonstrated successful establishment of osteoporosis. Three months after injection of CS, CS was completely degraded without any remains in bone tissue and the quality of bone tissue (amount and density of the bone tissue) in the CS group was significantly higher than that in the control group. The ultimate load, stiffness, and energy absorption in the CS group were all significantly higher than those in the control group. Conclusions: The preliminary data suggest that local injection of CS can significantly improve the amount, density, and biomechanical performance of the bone trabeculae in osteoporotic vertebra. The local injection of CS could also be used as a new method to improve the physical microstructure and augment the mechanical properties in "high-risk" vertebral bodies, decreasing the potential fracture risk of patients with osteoporosis. The strict inclusion and exclusion criteria should be performed before treatment.