Efficacy and Safety of Zoledronic Acid in Acute Spinal Cord Injury: Prevention of Bone Loss
| Status: | Terminated |
|---|---|
| Conditions: | Hospital, Orthopedic, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | March 2010 |
| End Date: | January 2016 |
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.
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.
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
We found this trial at
1
site
Rehabilitation Institute of Chicago The Rehabilitation Institute of Chicago (RIC) is an independent, 501(c)3, non-profit...
Click here to add this to my saved trials
