Study Stopped
difficulty in enrollment
Efficacy and Safety of Zoledronic Acid in Acute Spinal Cord Injury: Prevention of Bone Loss
1 other identifier
interventional
17
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2010
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2009
CompletedFirst Posted
Study publicly available on registry
February 16, 2009
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedResults Posted
Study results publicly available
May 8, 2017
CompletedJune 14, 2017
May 1, 2017
5.8 years
February 13, 2009
March 27, 2017
May 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bone Mass Density (BMD) at Total Hip
bone mineral density measured by DXA at the total hip
6 months
Secondary Outcomes (1)
BMD at Other Skeletal Sites
6 months
Study Arms (2)
zoledronic acid
EXPERIMENTALplacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Thomas J. Schnitzerlead
- Novartiscollaborator
Study Sites (1)
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611, United States
Related Publications (1)
Schnitzer TJ, Kim K, Marks J, Yeasted R, Simonian N, Chen D. Zoledronic Acid Treatment After Acute Spinal Cord Injury: Results of a Randomized, Placebo-Controlled Pilot Trial. PM R. 2016 Sep;8(9):833-43. doi: 10.1016/j.pmrj.2016.01.012. Epub 2016 Jan 30.
PMID: 26828618RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
please see publication for discussion; small sample size major limitation
Results Point of Contact
- Title
- Thomas Schnitzer
- Organization
- Northwestern University
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas J Schnitzer, MD, PhD
Northwestern University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
February 13, 2009
First Posted
February 16, 2009
Study Start
March 1, 2010
Primary Completion
December 1, 2015
Study Completion
January 1, 2016
Last Updated
June 14, 2017
Results First Posted
May 8, 2017
Record last verified: 2017-05