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

This study has been terminated.
(Incomplete data set & analysis)
Sponsor:
Collaborators:
United States Department of Defense
Spaulding Rehabilitation Hospital
VA Boston Healthcare System
Massachusetts General Hospital
Information provided by (Responsible Party):
Antonio Lazzari, Boston VA Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT01426555
First received: June 8, 2011
Last updated: March 11, 2016
Last verified: March 2016
  Purpose
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.

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:


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 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.


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 was planned to be compared to CT scans of the distal femur and proximal tibia.


Enrollment: 70
Study Start Date: February 2011
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: FES Rowing
Group 1 - FES-Rowing Exercise for entire study period
Other: FES-Rowing
FES- Rowing Exercise
Other Name: 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 Name: Rowing exercise
Drug: Zoledronic acid
5 mg IV single dose
Other Name: Reclast

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Massachusetts
Boston VAMC
Boston, Massachusetts, United States, 02130
Spaulding Rehab. Hospital
Charlestown, Massachusetts, United States, 02129
Sponsors and Collaborators
Antonio Lazzari
United States Department of Defense
Spaulding Rehabilitation Hospital
VA Boston Healthcare System
Massachusetts General Hospital
Investigators
Principal Investigator: Leslie Morse, DO Spaulding Rehab. Hospital
Principal Investigator: Antonio A Lazzari, MD Boston Division VAMC - New England
  More Information

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
Results First Received: January 14, 2016
Last Updated: March 11, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No
Plan Description: The study has been closed by the VABHS IRB.

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
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 02, 2016