Clinical Trial

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

Withdrawn Phase 2
View on ClinicalTrials.gov →
Why the trial stopped
Investigator left the institution
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
Protocol Amendment History 4 changes
critical Trial status changed: Not Yet Recruiting → Withdrawn 2026-06-05
critical Reason stopped changed: — → Investigator left the institution 2026-06-05
notable Enrollment reduced: 36 -> 0 participants 2026-06-05
notable Sponsor changed: Nitin Agarwal -> University of Pittsburgh 2026-06-05
Trial Details
NCT Number NCT06973109
Lead Sponsor University of Pittsburgh
Collaborators: Amgen, The Greg Beckwith Foundation
Conditions Osteoporosis, Post-menopausal
Start Date 2026-06-20
Primary Completion 2027-03-02 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2026-06-04