NCT00844480TerminatedPhase 2
Efficacy and Safety of Zoledronic Acid in Acute Spinal Cord Injury: Prevention of Bone Loss
Thomas J. Schnitzer1 site in 1 country17 target enrollmentStarted: March 2010Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Bone Mass Density (BMD) at Total Hip
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
zoledronic acid
Experimental
Intervention: zoledronic acid (Drug)
placebo
Placebo Comparator
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
Bone Mass Density (BMD) at Total Hip
Time Frame: 6 months
bone mineral density measured by DXA at the total hip
Secondary Outcomes
- BMD at Other Skeletal Sites(6 months)
Investigators
Thomas J. Schnitzer
professor
Northwestern University
Study Sites (1)
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