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

NCT01426555 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2016-04-11

Study results available
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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.

Conditions

Interventions

OTHER

FES-Rowing

FES- Rowing Exercise

DRUG

Zoledronic acid

5 mg IV single dose

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Spaulding Rehabilitation Hospital

    collaborator OTHER

  • VA Boston Healthcare System

    collaborator FED

  • Massachusetts General Hospital

    collaborator OTHER

  • Antonio Lazzari

    lead OTHER

Principal Investigators

  • Leslie Morse, DO · Spaulding Rehab. Hospital

  • Antonio A Lazzari, MD · Boston Division VAMC - New England

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01426555 on ClinicalTrials.gov