FES-Rowing Versus Zoledronic Acid to Improve Bone Health in Spinal Cord Injury (SCI)

March 11, 2016 updated by: Antonio Lazzari

FES-Rowing Versus Zoledronic Acid to Improve Bone Health in SCI: A Comparative Clinical Trial

This is a research study to determine the effects of functional electrical stimulation (FES) rowing and a drug called zoledronic acid in bone health. The investigators hoped to learn if zoledronic acid treatment will increase bone mineral density in persons with chronic spinal cord injury (SCI) who received it. The investigators also want to find out if zoledronic acid is safe for persons with SCI to take without causing too many side effects.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This research study was designed to determine the effects of functional electrical stimulation (FES) rowing and a drug called zoledronic acid in bone health in individuals who have suffered a spinal cord injury (SCI). The investigators hoped to learn if zoledronic acid treatment would increase bone mineral density in persons with chronic spinal cord injury. This was designed and conducted as a three center study with multiple investigators. The investigators also had a goal to find out if zoledronic acid is safe for persons with SCI without causing too many side effects.

The Prime recipient of funding is Spaulding Rehabilitation Hospital (SRH). Dr. Leslie Morse is the Principal Investigator for the study, the coordination of the study was located at Spaulding Rehabilitation Hospital. Through a sub-award a research group from the Veterans Administration of Boston Healthcare System was contracted to conduct DXA scans, blood draws and zoledronic acid administration to support this study. Through another sub-award from SRH, another Investigator from Massachusetts General Hospital (MGH) participated conducting CT scans for the study. All adverse events related to this study were to be monitored and recorded by investigators at SRH.

Seventy subjects age 18 years or older and wheelchair dependent at least 50% of the time because of an SCI were enrolled. Enrollment and initial screening for the study and follow up was performed at SRH. After enrollment the subjects were randomized to 1) FES-rowing alone or 2) FES-rowing plus a 1-time infusion of zoledronic acid. Following a variable period of strength training which was necessary for preparing quads and hamstrings for extended FES use, enrolled participants were planned to begin a regular rowing program for 12 months at the Cardiovascular Laboratory at the Spaulding Rehabilitation Hospital . DXA scans to measure bone mineral density were planned to be performed at the VA Boston Healthcare System-Jamaica Plain Campus (VABHS) three times during the study on all participants. In addition, 25 subjects in each arm of the study were planned to receive CT scans of their knees at MGH at the beginning and end of the study. Up to 20 subjects were to have an additional CT scan (at MGH) six months into rowing. Research blood samples were planned to be collected at VABHS five times during duration of the study and stored at the VA for further study of molecular markers of bone turnover. All participants were expected to be screened for renal function and calcium and vitamin D levels at the beginning and end of the study, with additional renal screening done before and after the zoledronic acid infusion. Calcium and vitamin D supplements were to be provided to each subject throughout the study. Those with insufficient vitamin D levels were to be provided additional repletion and planned to be periodically rechecked. Up to 15 male subjects were asked to have two echocardiograms at one of the SRH sites - one at the beginning of the study and the other halfway through the year-long rowing regimen.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 2
  • Phase 3

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
    • Massachusetts
      • Boston, Massachusetts, United States, 02130
        • Boston Vamc
      • Charlestown, Massachusetts, United States, 02129
        • Spaulding Rehab. Hospital

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 to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • male and female SCI outpatients
  • women of child bearing age will be required to use an acceptable birth control method throughout the study
  • aged 18 - over the age of 40
  • physician's cardiac clearance to exercise
  • who were at least age 14 at time of injury
  • who are at least 18 months post injury
  • who have a C4 spinal cord injury or lower

Exclusion Criteria:

  • initial blood pressure higher than 140/90
  • patients with orthostatic hypotension
  • an active grade 2 or greater pressure ulcers
  • lower extremity contractures
  • history of significant arrhythmias
  • coronary disease
  • diabetes
  • neurological or renal disease
  • cancer
  • other neurological disease (i.e. stroke, peripheral neuropathy, myopathy)
  • any implanted electronic device
  • active treatment for epilepsy
  • recent weight change
  • regular use of tobacco
  • family history of arrhythmia or sudden cardiac death
  • current use of cardioactive or antidepressant medications
  • current use of medications that may affect fracture risk including:
  • bisphosphonates
  • PTH and PTH analogs
  • androgenic steroids
  • estrogenic steroids
  • glucocorticoids
  • antiepileptics
  • lithium.
  • Any subject with a planned invasive dental procedure will be excluded.

These criteria will be reviewed by telephone survey followed by a health exam where blood pressure will be assessed and a skin and neurological exam performed.

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: FES Rowing
Group 1 - FES-Rowing Exercise for entire study period
Other: FES-Rowing
FES- Rowing Exercise
Other Names:
  • Rowing exercise
EXPERIMENTAL: FES Rowing + Zoledronic acid
Group 2 - FES-Rowing Exercise for entire study period plus Zoledronic Acid 5mg administered by i.v. infusion one-time at the end of observation period
Other: FES-Rowing
FES- Rowing Exercise
Other Names:
  • Rowing exercise
Drug: Zoledronic acid
5 mg IV single dose
Other Names:
  • Reclast

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of Bone Mass as Measured by Sequential Evaluation of Bone Density and Bone Structure
Time Frame: 12 months
This work was designed to determine if FES-rowing plus Zoledronic acid is superior to FES-rowing alone reversing deterioration and weakening of the bones due to SCI and was planned to confirm the effects of FES-rowing in bone structure in patients not receiving Zoledronic Acid.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of DXA Scanning in Patients With SCI
Time Frame: 12 months
This study has been designed to evaluate whether sequential DXA scanning of the distal femur and proximal femur is an appropriate clinical tool to monitor bone changes in response to either treatment. Evaluation of bone density by DXA was planned to be compared to CT scans of the distal femur and proximal tibia.
12 months

Collaborators and Investigators

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

Sponsor

Antonio Lazzari

Collaborators

Massachusetts General Hospital
United States Department of Defense
Spaulding Rehabilitation Hospital
VA Boston Healthcare System

Investigators

  • Principal Investigator: Leslie Morse, DO, Spaulding Rehab. Hospital
  • Principal Investigator: Antonio A Lazzari, MD, Boston Division VAMC - New England

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

February 1, 2011

Primary Completion (ACTUAL)

February 1, 2015

Study Completion (ACTUAL)

February 1, 2015

Study Registration Dates

First Submitted

June 8, 2011

First Submitted That Met QC Criteria

August 30, 2011

First Posted (ESTIMATE)

August 31, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

April 11, 2016

Last Update Submitted That Met QC Criteria

March 11, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 109241

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The study has been closed by the VABHS IRB.

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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