Status:
TERMINATED
FES-Rowing Versus Zoledronic Acid to Improve Bone Health in Spinal Cord Injury (SCI)
Lead Sponsor:
Antonio Lazzari
Collaborating Sponsors:
United States Department of Defense
Spaulding Rehabilitation Hospital
Conditions:
Osteoporosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
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 aci...
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 c...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01426555
Start Date
February 1 2011
End Date
February 1 2015
Last Update
April 11 2016
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Boston VAMC
Boston, Massachusetts, United States, 02130
2
Spaulding Rehab. Hospital
Charlestown, Massachusetts, United States, 02129