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

Osteoporosis Clinical Trial

Official title:

FES-Rowing Versus Zoledronic Acid to Improve Bone Health in SCI: A Comparative Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01426555
• Other study ID #: 109241
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: June 8, 2011
• Last updated: March 8, 2016
• Start date: February 2011
• Est. completion date: February 2015

Study information

• Verified date: March 2016
• Source: Boston VA Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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 receive 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Other:
• FES-Rowing
FES- Rowing Exercise

Drug:
• Zoledronic acid
5 mg IV single dose

Locations

Country	Name	City	State
United States	Boston VAMC	Boston	Massachusetts
United States	Spaulding Rehab. Hospital	Charlestown	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
Antonio Lazzari	Massachusetts General Hospital, Spaulding Rehabilitation Hospital, United States Department of Defense, VA Boston Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Validation of DXA Scanning in Patients With SCI	This study has been designed to evaluate whether sequential DXA scanning of the distal femur and proximal femur is an appropriate clinical tool to monitor bone changes in response to either treatment. Evaluation of bone density by DXA was planned to be compared to CT scans of the distal femur and proximal tibia.	12 months	Yes