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

Primary Purpose

Bone Loss

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
zoledronic acid
placebo
Sponsored by
Thomas J. Schnitzer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bone Loss focused on measuring spinal cord injury, osteoporosis, bone loss, zoledronic acid, bisphosphonate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rehabilitation Institute of Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

zoledronic acid

placebo

Arm Description

Outcomes

Primary Outcome Measures

Bone Mass Density (BMD) at Total Hip
bone mineral density measured by DXA at the total hip

Secondary Outcome Measures

BMD at Other Skeletal Sites
BMD at spine, femoral neck, distal femur, proximal tibia, heel

Full Information

First Posted
February 13, 2009
Last Updated
May 16, 2017
Sponsor
Thomas J. Schnitzer
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00844480
Brief Title
Efficacy and Safety of Zoledronic Acid in Acute Spinal Cord Injury: Prevention of Bone Loss
Official Title
Efficacy and Safety of Zoledronic Acid in Acute Spinal Cord Injury: Prevention of Bone Loss
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
difficulty in enrollment
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Thomas J. Schnitzer
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Loss
Keywords
spinal cord injury, osteoporosis, bone loss, zoledronic acid, bisphosphonate

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
zoledronic acid
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
zoledronic acid
Other Intervention Name(s)
Reclast, zoledronic acid
Intervention Description
zoledronic acid, 5mg, iv
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
iv
Primary Outcome Measure Information:
Title
Bone Mass Density (BMD) at Total Hip
Description
bone mineral density measured by DXA at the total hip
Time Frame
6 months
Secondary Outcome Measure Information:
Title
BMD at Other Skeletal Sites
Description
BMD at spine, femoral neck, distal femur, proximal tibia, heel
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas J Schnitzer, MD, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehabilitation Institute of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26828618
Citation
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.
Results Reference
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Efficacy and Safety of Zoledronic Acid in Acute Spinal Cord Injury: Prevention of Bone Loss

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