Osteoporosis | FES-Rowing Versus Zoledronic Acid to Improve Bone Health in Spinal Cord Injury (SCI)
Osteoporosis research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Other:FES-RowingFES- Rowing Exercise
Drug:Zoledronic acid5 mg IV single dose
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
FES RowingGroup 1 - FES-Rowing Exercise for entire study period
FES Rowing + Zoledronic acidGroup 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
Start Date: February 2011
Completed Date: February 2015
Phase: Phase 2/Phase 3
Primary Outcome: Improvement of Bone Mass as Measured by Sequential Evaluation of Bone Density and Bone Structure
Secondary Outcome: Validation of DXA Scanning in Patients With SCI
Study sponsors, principal investigator, and references
Principal Investigator: Leslie Morse, DO
Lead Sponsor: Antonio Lazzari
Collaborator: United States Department of Defense