Prevention of Bone Loss After Acute SCI by Zoledronic Acid

June 8, 2021 updated by: Thomas J. Schnitzer, Northwestern University

Prevention of Bone Loss After Acute SCI by Zoledronic Acid: Durability, Effect on Bone Strength, and Use of Biomarkers to Guide Therapy

The overall objective of this study is to define an effective therapeutic approach, using currently available medication, to prevent or mitigate the loss of bone mass and bone strength that occurs after acute spinal cord injury.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, double-blind placebo-controlled study of zoledronic acid to evaluate its efficacy and safety over a 2 year period for the prevention of bone loss and maintenance of bone strength in individuals with recent onset SCI (see diagram below). Subjects will be randomized at the baseline visit to receive either zoledronic acid or placebo. At the end of the first year of the study, each treatment group will be re-randomized to either zoledronic acid or placebo to evaluate the durability of response to zoledronic acid and the utility of serum bone markers to guide therapeutic decision making. DXA imaging, CT imaging and bone markers will be obtained at baseline, 3 months, 6 months, 12 months, 18 months and 24 months.

Study Type

Interventional

Enrollment (Actual)

60

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
        • Northwestern University Feinberg School of Medicine
      • 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:

  • In-patient at Rehabilitation Institute of Chicago (RIC) or an outpatient who was recently discharged from RIC
  • Males and females
  • Age >/=18 years
  • Medically stable in the opinion of subject's physiatrist
  • SCI at within 120 days inclusive at time of screening
  • SCI with inability to ambulate independently
  • ASIA Impairment Scale (AIS) A, B, or C, at time of study entry
  • Capable of positioning to have DXA performed
  • Able to tolerate acetaminophen
  • No known endocrinopathies (diabetes type 1 or 2 can be included)
  • Normal TSH levels
  • Normal 25-OH vitamin D levels (>/= 20 ng/ml) at baseline (subjects may be repleted)
  • Normal calcium levels
  • Normal renal function (creatinine <2.0 mg/dl)
  • Well hydrated with adequate intake of liquids
  • Able to return for all follow-up visits
  • Capable of reading and understanding informed consent document
  • Males and females of childbearing potential must be willing and able to use double barrier method of contraception for 2 months after having received study drug

Exclusion Criteria:

  • Have Paget's disease of the bone
  • Malignancy as a cause of acute SCI
  • Have unexplained high levels of alkaline phosphatase in blood
  • Any active gastrointestinal condition that results in malabsorption
  • Poor dental hygiene or requirement for invasive dental procedure within two months prior to enrollment
  • History of bone metastasis and skeletal malignancies
  • History of alcoholism or drug abuse within the 2 years prior to study screening
  • Other medical conditions that in the opinion of the investigator would preclude the subject from completing the study
  • Elevated liver function tests >2x normal
  • Currently being prescribed anti-convulsants at a dose or frequency that is determined to interfere with bone metabolism as determined by the investigator
  • Currently being prescribed glucocorticoids, other than inhaled glucocorticoids
  • Current or recent use any bone-active agents, including any bisphosphonate, raloxifene, hormone therapy (estrogen and estrogen/progestin), calcitonin or strontium-containing compounds within 60 days of screening.
  • Pregnant, planning to become pregnant, or lactating

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zol
Intravenous infusion of zoledronic acid (zol) 5 mg at baseline.
Drug: Zoledronic acid
Intravenous infusion of zoledronic acid 5 mg.
Other Names:
  • Reclast
  • Zometa
  • Bisphosphonate
Experimental: Placebo
Intravenous infusion of placebo at baseline.
Drug: Placebo
Placebo (saline) infusion to match zoledronic acid
Other Names:
  • Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change in Bone Mass Density (BMD) in the Hip
Time Frame: 0-12 months
Percent change of bone mass density (BMD) in the total hip (as measured by DXA)
0-12 months
Percent Change of Bone Mass Density (BMD) in the Femoral Neck
Time Frame: 0-12 months
Percent change of bone mass density (BMD) in the femoral neck (as measured by DXA)
0-12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change in the Epiphyseal Integral Bone Mass Content (iBMC) of the Femur
Time Frame: 0-12 months
Percent change in the epiphyseal integral bone mass content (iBMC) of the femur, as collected by CT.
0-12 months
Percent Change in the Metaphyseal Integral Bone Mass Content (iBMC) of the Femur
Time Frame: 0-12 months
Percent change in the metaphyseal integral bone mass content (iBMC) of the femur, as collected by CT
0-12 months

Collaborators and Investigators

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

Sponsor

Northwestern University

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: Thomas J Schnitzer, MD, PhD, Northwestern University Feinberg School of Medicine

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 (Actual)

February 1, 2015

Primary Completion (Actual)

August 25, 2020

Study Completion (Actual)

August 25, 2020

Study Registration Dates

First Submitted

December 21, 2014

First Submitted That Met QC Criteria

December 24, 2014

First Posted (Estimate)

December 25, 2014

Study Record Updates

Last Update Posted (Actual)

June 29, 2021

Last Update Submitted That Met QC Criteria

June 8, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00098239
  • A-18350 (Other Grant/Funding Number: Department of Defense)

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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