Efficacy and Safety of Zoledronic Acid in Acute Spinal Cord Injury: Prevention of Bone Loss
- Registration Number
- NCT00844480
- Lead Sponsor
- Thomas J. Schnitzer
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 17
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo placebo - zoledronic acid zoledronic acid -
- Primary Outcome Measures
Name Time Method Bone Mass Density (BMD) at Total Hip 6 months bone mineral density measured by DXA at the total hip
- Secondary Outcome Measures
Name Time Method BMD at Other Skeletal Sites 6 months BMD at spine, femoral neck, distal femur, proximal tibia, heel
Trial Locations
- Locations (1)
Rehabilitation Institute of Chicago
🇺🇸Chicago, Illinois, United States