NCT01426555

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2011

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2011

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 31, 2011

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 10, 2016

Completed
Last Updated

April 11, 2016

Status Verified

March 1, 2016

Enrollment Period

4 years

First QC Date

June 8, 2011

Results QC Date

January 14, 2016

Last Update Submit

March 11, 2016

Conditions

Osteoporosis

Keywords

Disorder of Bone Density and Structure, UnspecifiedWeakening of the bone structure

Outcome Measures

Primary Outcomes (1)

  • Improvement of Bone Mass as Measured by Sequential Evaluation of Bone Density and Bone Structure

    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 Outcomes (1)

  • Validation of DXA Scanning in Patients With SCI

    12 months

Study Arms (2)

FES Rowing

ACTIVE COMPARATOR

Group 1 - FES-Rowing Exercise for entire study period

Other: FES-Rowing

FES Rowing + Zoledronic acid

EXPERIMENTAL

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-RowingDrug: Zoledronic acid

Interventions

FES-RowingOTHER

FES- Rowing Exercise

Also known as: Rowing exercise
FES RowingFES Rowing + Zoledronic acid
Zoledronic acidDRUG

5 mg IV single dose

Also known as: Reclast
FES Rowing + Zoledronic acid

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Boston VAMC

Boston, Massachusetts, 02130, United States

Location

Spaulding Rehab. Hospital

Charlestown, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Limitations and Caveats

No Data Safety Monitor Board established for this project. Incomplete data set and analysis.

Results Point of Contact

Title
Dr. Antonio Lazzari
Organization
VA Boston Healthcare System
antonio.lazzari@va.gov
857-364-6381

Study Officials

  • Leslie Morse, DO

    Spaulding Rehab. Hospital

    PRINCIPAL INVESTIGATOR

  • Antonio A Lazzari, MD

    Boston Division VAMC - New England

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

June 8, 2011

First Posted

August 31, 2011

Study Start

February 1, 2011

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

April 11, 2016

Results First Posted

March 10, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

The study has been closed by the VABHS IRB.

Locations

US(2)