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

• Status: Terminated
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Antonio Lazzari
• Collaborators: Massachusetts General Hospital; Spaulding Rehabilitation Hospital; United States Department of Defense; VA Boston Healthcare System
• Treatments: Diphosphonates; Zoledronic Acid

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.