Evaluation of Romosozumab vs. Zoledronic Acid Effect in Patients With Spinal Cord Injury and Low Bone Mineral Density

• Status: Not yet recruiting
• Trial end date: 2023-11-15
• Target enrollment: 0
• Participant gender: Female

Summary

This is a randomized study to determine the effects of monthly romosozumab for one year or one-time zoledronic acid on bone mineral density (BMD) and biochemical markers of bone formation and resorption, in patients with spinal cord injury (SCI) and low BMD.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sheba Medical Center
• Treatments: Zoledronic Acid

Criteria

Inclusion Criteria:

• BMD T-score ≤ -2.0 at the lumbar spine, total hip or femoral neck

• SCI of at least 24-month but less than 7 years duration,

• American Spinal Injury Association (ASIA) Impairment Scale A-C

Exclusion Criteria:

• myocardial infarction (MI) or stroke within the preceding year

• high cardiovascular risk, 10 years Framingham score over 20 %.