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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Thomas J. Schnitzer, Northwestern University
ClinicalTrials.gov Identifier:
NCT00844480
First received: February 13, 2009
Last updated: December 5, 2013
Last verified: December 2013
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Northwestern University:

Primary Outcome Measures:
  • Bone mass density (BMD) at distal femur [ Time Frame: 3,6, and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • BMD at proximal tibia, hip, spine, heel and forearm [ Time Frame: 3,6, and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 34
Study Start Date: March 2010
Estimated Study Completion Date: December 2015
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Thomas J. Schnitzer, professor, Northwestern University
ClinicalTrials.gov Identifier: NCT00844480     History of Changes
Other Study ID Numbers: RIC-TJS003
Study First Received: February 13, 2009
Last Updated: December 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Northwestern University:
spinal cord injury
osteoporosis
bone loss
zoledronic acid
bisphosphonate

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

ClinicalTrials.gov processed this record on August 28, 2014