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Sponsors and Collaborators: |
Northwestern University Rehabilitation Institute of Chicago |
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Information provided by: | Northwestern University |
ClinicalTrials.gov Identifier: | NCT00462683 |
The purpose of the study is to evaluate the state of bone health of brain injury patients being seen within a rehabilitation setting. Osteopenia is a condition of bone in which decreased calcification, decreased density, or reduced mass occurs. Osteoporosis is a disease in which the bones become extremely porous, are subject to fracture, and heal slowly. More specifically, the prevalence of osteopenia and osteoporosis at specific anatomic locations (e.g., forearms, hips, spine) will be determined as will specific interventions (e.g., use of vitamins, nutritional supplements, specific prescription medications) that people with brain injury may be applying, or have applied, to manage their bone health. An attempt will also be made to evaluate severity of brain injury, based on loss of muscle strength/function, and to compare this data with bone-focused information such as bone mineral density (BMD), falls, and history.
Condition |
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Stroke Anoxia Brain Injury |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Bone Loss, Fractures, and Management of Bone Health in People With Stroke in Managed Rehabilitation Settings |
Two 10ml tubes of blood will be obtained from each participant. Serum will be separated and frozen to be saved for possible measurement of vitamin D levels and/or bone markers.
Estimated Enrollment: | 200 |
Study Start Date: | July 2007 |
Primary Outcomes: As this study has no control or comparator group, the goal will be to provide descriptive data regarding the prevalence of osteopenia and osteoporosis at each of the anatomic sites evaluated by DEXA in this specialized population (BMD outcome measures). Additionally, the use of bone-specific interventions (vitamins, nutritional supplements, medications), previous diagnostic testing (DEXA) and history of falls and fractures will be assessed to determine the extent to which bone health has been considered and evaluated in this population of individuals at increased risk of fracture.
Secondary Outcomes: Functional status measures will also be obtained to enable correlation with bone data.
This study involves a cross-sectional, descriptive evaluation of a cohort of 225 patients with brain injury who are being managed at the out-patient clinics by physicians from RIC. The goal of the study is to provide representative data of both the general bone health of this population of patients (degree, extent and localization of bone loss) as well as interventions that may have been implemented to manage their bone health (vitamins, nutritional supplements, prescription medications). After obtaining informed consent, those patients who wish to be involved will be asked to complete a medical history questionnaire that focuses on bone health and will then undergo measurement of bone density by DEXA (dual energy X-ray absorptiometry). At the time of the DEXA examination, muscle strength will be evaluated by a trained research coordinator. A dietary history and a blood sample will also be obtained, the latter for storage in order to later measure vitamin D levels and/or other bone markers. All subjects will then be given the opportunity to continue in the longitudinal arm of the study (second phase). Those who do will sign the informed consent and will then be re-evaluated at yearly intervals with the same set of data being obtained.
Descriptive Data to be Obtained:
Detailed and complete medical history, with particular focus on:
Study procedures:
1. DEXA evaluation. Specific measurements will be made for lumbar spine, hip and distal radius; lateral vertebral assessment will be obtained if possible.
Biological Samples:
1. Two 10ml tubes of blood will be obtained from each participant. Serum will be separated and frozen in two aliquots to be saved for possible measurement of vitamin D levels (25OH vitamin D) and/or bone markers.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Subjects who have experienced brain injury.
Inclusion Criteria:
Exclusion Criteria:
Contact: Thomas J Schnitzer, MD, PhD | 312-649-2964 | tjs@northwestern.edu |
United States, Illinois | |
Rehabilitation Institute of Chicago | Recruiting |
Chicago, Illinois, United States, 60611 | |
Contact: Lisa Stregg, RN 312-238-2816 lstreff@ric.org | |
Principal Investigator: Thomas J Schnitzer, MD, PhD | |
Sub-Investigator: Richard Harvey, MD, PhD | |
Sub-Investigator: Elliot Roth, MD | |
Northwestern University | Recruiting |
Chicago, Illinois, United States, 60611 | |
Contact: Lisa Streff, RN 312-238-2816 lstreff@ric.org | |
Principal Investigator: Thomas J Schnitzer, MD, PhD |
Principal Investigator: | Thomas J Schnitzer, MD, PhD | Northwestern Univesity & Rehabilitation Institute of Chicago |
Principal Investigator: | Richard Harvey, MD, PhD | Rehabilitation Institute of Chicago |
Principal Investigator: | Elliot Roth, MD | Rehabilitation Institute of Chicago |
Responsible Party: | Northwestern University ( Thomas J. Schnitzer, MD, PhD ) |
Study ID Numbers: | NURIC0445100 |
Study First Received: | April 18, 2007 |
Last Updated: | November 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00462683 |
Health Authority: | United States: Federal Government |
Stroke Anoxia Brain Injury |
Rehabilitation Osteoporosis Osteopenia |
Craniocerebral Trauma Cerebral Infarction Stroke Fractures, Bone Wounds and Injuries Vascular Diseases Disorders of Environmental Origin Osteoporosis Central Nervous System Diseases Trauma, Nervous System |
Ischemia Brain Diseases Cerebrovascular Disorders Anoxia Signs and Symptoms Brain Ischemia Signs and Symptoms, Respiratory Brain Infarction Brain Injuries Infarction |
Nervous System Diseases Cardiovascular Diseases |