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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Bone Loss

In brief

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.

Key facts

Study ID

NCT00844480

Run by

Thomas J. Schnitzer

People needed

17

Starts

2010-03-01

Expected to finish

2016-01-01

Last updated by the study team

2017-06-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Rehabilitation Institute of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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