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

This study is currently recruiting participants.
Verified July 2012 by Boston VA Research Institute, Inc.
Sponsor:
Collaborator:
Department of Defense
Information provided by (Responsible Party):
Antonio Lazzari, Boston VA Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT01426555
First received: June 8, 2011
Last updated: July 24, 2012
Last verified: July 2012
History of Changes
  Purpose

This is a research study that will determine the facts of functional electrical stimulation (FES) rowing and a drug called zoledronic acid in bone health. The investigators hope to learn if zoledronic acid treatment will increase bone mineral density in persons with chronic spinal cord injury (SCI) who receive 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.


Condition Intervention Phase
Osteoporosis
 Other: FES-Rowing
Drug: Zoledronic acid
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: FES-Rowing Versus Zoledronic Acid to Improve Bone Health in SCI: A Comparative Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boston VA Research Institute, Inc.:

Primary Outcome Measures:
  • Improvement of bone mass as measured by sequential evaluation of bone density and bone structure [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    This work will determine if FES-rowing plus Zoledronic acid is superior to FES-rowing alone to reverse deterioration and weakening of the bones due to SCI and will confirm the effects of FES-rowing in bone structure in patients not receiving Zoledronic acid or other bisphosphonates. This study seeks to answer the question of whether zoledronic acid and FES-rowing have a greater impact on bone mineral density than FES-rowing alone.


Secondary Outcome Measures:
  • Validation of DXA Scanning in patients with SCI [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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 will be compared to CT scans of the distal femur and proximal tibia.


Estimated Enrollment: 70
Study Start Date: February 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Functional Electrical Stimulation (FES) Rowing Other: FES-Rowing
Exercise
Other Name: Rowing exercise
Experimental: FES Rowing with Zoledronic Acid Drug: Zoledronic acid
5 mg IV single dose
Other Name: Reclast

Detailed Description:

This is a research study that will determine the facts of functional electrical stimulation (FES) rowing and a drug called zoledronic acid in bone health. The investigators hope to learn if zoledronic acid treatment will increase bone mineral density in persons with chronic spinal cord injury (SCI) who receive 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01426555

Contacts
Contact: Leslie Morse, DO 617 573 2913 lmorse4@partners.org
Contact: Cathy Wolff, B.J. 617-573-2197 cwolff@partners.com

Locations
United States, Massachusetts
Spaulding Rehab. Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Cathy Wolff, B.J.     617-573-2197     cwolff@partners.org    
Contact: Supreetha Sudhakar, MPH     617 573 2133        
Principal Investigator: Leslie Morse, DO            
Boston VAMC Recruiting
Boston, Massachusetts, United States, 02130
Contact: Samuel A Davis     857-364-6381     Samuel.davis2@va.gov    
Principal Investigator: Antonio A Lazzari, MD, PhD            
Sponsors and Collaborators
Antonio Lazzari
Department of Defense
Investigators
Principal Investigator: Leslie Morse, DO Spaulding Rehab. Hospital
Principal Investigator: Antonio A Lazzari, MD Boston Division VAMC - New England
  More Information

No publications provided

Responsible Party: Antonio Lazzari, PI, Boston VA Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01426555     History of Changes
Other Study ID Numbers: 109241
Study First Received: June 8, 2011
Last Updated: July 24, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston VA Research Institute, Inc.:
Disorder of Bone Density and Structure, Unspecified
Weakening of the bone structure

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

ClinicalTrials.gov processed this record on May 21, 2013