NCT04708886

Romosozumab in Women With Chronic SCI

Effects of Romosozumab on Bone Health in Women With Spinal Cord Injury and Osteoporosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This two-year open-label pilot clinical trial will evaluate the efficacy and safety of romosozumab to treat bone loss in females with chronic spinal cord injury (SCI) and osteoporosis (OP). Participants will receive monthly injections of romosozumab during the first 12 months of the study. During the second year, participants will take oral alendronate tablets on a weekly basis.

Detailed description

This is a single-site, singe-arm, open-label pilot study to evaluate safety and efficacy of a sequential drug treatment (12 months of romosozumab injections followed by 12 months with alendronate tablets) to treat bone loss in women with chronic SCI and OP. During the first year, participants will receive monthly subcutaneous injections of romosozumab 210 mg. This drug works by increasing bone formation and is FDA-approved for treating OP in post-menopausal women at high risk of fracture or those who did not benefit from using other available OP treatments. During the second year, participants will take weekly oral alendronate 70 mg. Alendronate is FDA-approved for the treatment of osteopenia and the treatment of OP in post-menopausal women and men as well as for the prevention and treatment of glucocorticoid-induced OP. In this study, it will be used to help maintain any increases in bone mass gained from the year of treatment with romosozumab. Twelve participants will receive the study drug treatment, take daily supplements (calcium and vitamin D), and return to the research site for study visits over the course of two years. Computerized tomography (CT) imaging, dual-energy X-ray absorptiometry (DXA) imaging, and serum bone markers will be collected at various time points.

Conditions

• Osteoporosis
• Bone Loss
• Osteopenia, Osteoporosis
• Spinal Cord Injuries
• Chronic Spinal Paralysis

Interventions

Type	Name	Description
DRUG	Romosozumab	Year 1 study drug
DRUG	Alendronate	Year 2 study drug

Timeline

• Start date: 2021-03-01
• Primary completion: 2024-06-10
• Completion: 2024-06-10
• First posted: 2021-01-14
• Last updated: 2025-09-24
• Results posted: 2025-09-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study