Status:
TERMINATED
Efficacy and Safety of Zoledronic Acid in Acute Spinal Cord Injury: Prevention of Bone Loss
Lead Sponsor:
Thomas J. Schnitzer
Collaborating Sponsors:
Novartis
Conditions:
Bone Loss
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 evaluat...
Eligibility Criteria
Inclusion
- Men and women
- Age 18 years and older
- Spinal cord injury within 8 weeks of study entry
- ASIA AIS A or B
- Medically stable in the opinion of their physiatrist
- Able to have dexa performed
- Able to return for follow-up at 6 and 12 months
Exclusion
- Vitamin D deficiency
- Hypocalcemia
- Renal insufficiency (estimated creatinine clearance \<30ml/min)
- Abnormal thyroid hormone status
- Abnormal mental status
- Osteoporosis at the hip or spine by dexa
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00844480
Start Date
March 1 2010
End Date
January 1 2016
Last Update
June 14 2017
Active Locations (1)
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1
Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60611