NCT06973109

Romosozumab Effects on Bone Density, Muscle Mass, and Spine Surgery Outcomes

Investigating the Efficacy of Romosozumab in Augmenting Bone Density and Muscle Mass to Enhance the Outcomes of Spine Surgery

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Nitin Agarwal · Academic / Other
• Sex: Female
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if romosozumab (Evenity) can improve bone and muscle health in postmenopausal women with osteoporosis who are undergoing lumbar spine surgery. The main questions it aims to answer are: * Does romosozumab improve bone strength and reduce the risk of complications during and after spine surgery? * Does romosozumab increase muscle mass and help patients recover better from surgery? Researchers will compare romosozumab (a monthly injection) to alendronate (a weekly pill), both approved treatments for osteoporosis, to see which is more effective in this surgical setting. Participants will: * Be randomly assigned to receive romosozumab or alendronate * Take standard vitamin supplements and receive a one-time dose of zoledronic acid near the end of the study * Attend five study visits over about 12 months * Undergo bone scans, muscle imaging, and complete health questionnaires before and after surgery

Conditions

• Osteoporosis, Post-menopausal

Interventions

Type	Name	Description
DRUG	Romosozumab	Monthly subcutaneous injection (210 mg total dose) administered as two separate 105 mg injections, one per arm. Administered for 12 months to female patients ≥65 years undergoing spine surgery.
DRUG	Alendronate (Fosamax)	Weekly oral dose (70 mg) administered for 12 months. Used as active comparator in control arm of study.
DRUG	Placebo Romosozumab	Monthly subcutaneous injections mimicking romosozumab in appearance and administration schedule. Administered to control group.
DRUG	Placebo Alendronate	Weekly oral placebo pill mimicking alendronate. Administered to treatment group.

Timeline

• Start date: 2026-03-20
• Primary completion: 2027-03-02
• Completion: 2027-06-01
• First posted: 2025-05-15
• Last updated: 2026-03-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study