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

This study has been terminated.
(difficulty in enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00844480
First Posted: February 16, 2009
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novartis
Information provided by (Responsible Party):
Thomas J. Schnitzer, Northwestern University
  Purpose
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.

Condition Intervention Phase
Bone Loss Drug: zoledronic acid Drug: placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy and Safety of Zoledronic Acid in Acute Spinal Cord Injury: Prevention of Bone Loss

Resource links provided by NLM:


Further study details as provided by Thomas J. Schnitzer, Northwestern University:

Primary Outcome Measures:
  • Bone Mass Density (BMD) at Total Hip [ Time Frame: 6 months ]
    bone mineral density measured by DXA at the total hip


Secondary Outcome Measures:
  • BMD at Other Skeletal Sites [ Time Frame: 6 months ]
    BMD at spine, femoral neck, distal femur, proximal tibia, heel


Enrollment: 17
Study Start Date: March 2010
Study Completion Date: January 2016
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: zoledronic acid Drug: zoledronic acid
zoledronic acid, 5mg, iv
Other Name: Reclast, zoledronic acid
Placebo Comparator: placebo Drug: placebo
iv

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00844480


Locations
United States, Illinois
Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Thomas J. Schnitzer
Novartis
Investigators
Principal Investigator: Thomas J Schnitzer, MD, PhD Northwestern University
  More Information

Publications:
Responsible Party: Thomas J. Schnitzer, professor, Northwestern University
ClinicalTrials.gov Identifier: NCT00844480     History of Changes
Other Study ID Numbers: RIC-TJS003
First Submitted: February 13, 2009
First Posted: February 16, 2009
Results First Submitted: March 27, 2017
Results First Posted: May 8, 2017
Last Update Posted: June 14, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Thomas J. Schnitzer, Northwestern University:
spinal cord injury
osteoporosis
bone loss
zoledronic acid
bisphosphonate

Additional relevant MeSH terms:
Spinal Cord Injuries
Bone Diseases, Metabolic
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Bone Diseases
Musculoskeletal Diseases
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs