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

May 16, 2017 updated by: Thomas J. Schnitzer
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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Rehabilitation Institute of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: placebo
iv
Experimental: zoledronic acid
Drug: zoledronic acid
zoledronic acid, 5mg, iv
Other Names:
  • Reclast, zoledronic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone Mass Density (BMD) at Total Hip
Time Frame: 6 months
bone mineral density measured by DXA at the total hip
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMD at Other Skeletal Sites
Time Frame: 6 months
BMD at spine, femoral neck, distal femur, proximal tibia, heel
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas J. Schnitzer

Collaborators

Novartis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

February 13, 2009

First Submitted That Met QC Criteria

February 13, 2009

First Posted (Estimate)

February 16, 2009

Study Record Updates

Last Update Posted (Actual)

June 14, 2017

Last Update Submitted That Met QC Criteria

May 16, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIC-TJS003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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