Efficacy and Safety of Zoledronic Acid in Acute Spinal Cord Injury: Prevention of Bone Loss

• Status: Terminated
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a double-blind, randomized, placebo-controlled trial of zoledronic acid, 5mg, to be administered intravenously to people who have suffered an acute spinal cord fracture. The goal is to evaluate if zoledronic acid can prevent the acute bone loss seen in this population. Outcome measures will include bone density determinations over a one year period.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas J. Schnitzer
• Collaborator: Novartis
• Treatments: Diphosphonates; Zoledronic Acid

Criteria

Inclusion Criteria:

1. Men and women

2. Age 18 years and older

3. Spinal cord injury within 8 weeks of study entry

4. ASIA AIS A or B

5. Medically stable in the opinion of their physiatrist

6. Able to have dexa performed

7. Able to return for follow-up at 6 and 12 months

Exclusion Criteria:

1. Vitamin D deficiency

2. Hypocalcemia

3. Renal insufficiency (estimated creatinine clearance <30ml/min)

4. Abnormal thyroid hormone status

5. Abnormal mental status

6. Osteoporosis at the hip or spine by dexa