Utilizing AI to Investigate the Efficacy of Romosozumab in Boosting Bone Density and Muscle Mass for Improved Spine Surgery Outcomes

Grant Application

Primary Investigator: Nitin Agarwal, MD

Co-Investigators: D. Kojo Hamilton, MD, Nami S. Haeri, MD, Rohit Premkumar, BA, and Taim Aizooky, BS

Proposed Innovation

Bone health and muscle strength are predictors for how well patients will do after spine surgery. But older patients often develop osteoporosis (a bone disease that develops when bone mineral density and bone mass decrease) and sarcopenia (the loss of muscle and strength due to decreased physical activity). Both diseases can increase the risk of surgical complications.

Investigators in this project are testing the hypothesis that providing romosozumab — an FDA- approved drug for treatment of osteoporosis — prior to surgery can improve outcomes for those patients with muscle wasting and thinning of the bones.

Improvements in Action

This 2-year, double-blinded study will involve 24 patients with osteoporosis and sarcopenia. Three months prior to spinal fusion surgery, half of the patients will be part of a treatment cohort that receives romosozumab. The other half will be part of a control group that receives alendronate, a widely prescribed osteoporosis medication.

Researchers will then measure bone density and muscle mass before and after surgery to determine the drug’s effectiveness. These measurements will be obtained manually using imaging scans and further validated through an artificial intelligence (AI) tool. The researchers also will compare the rate of post-surgical complications between the two groups.

Intended Outcomes

Researchers believe that providing romosozumab to patients with osteoporosis and sarcopenia prior to spinal fusion surgery will boost bone density and muscle mass. This is expected to improve outcomes with better function, fewer complications, and a decreased rate of revision surgery.