Bone Loss, Fractures, and Management of Bone Health in People With Stroke in Managed Rehabilitation Settings
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|ClinicalTrials.gov Identifier: NCT00462683|
Recruitment Status : Completed
First Posted : April 19, 2007
Last Update Posted : January 6, 2012
|Condition or disease|
|Stroke Anoxia Brain Injury|
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:
- Demographics: date of birth, sex, race, ethnicity
Detailed and complete medical history, with particular focus on:
- Information regarding brain injury: time of occurrence, motor/sensory, etc.
- Bone specific information: history of falls, fractures, use of medications, smoking, alcohol, family history of osteoporosis and fractures, previous DEXA, etc.
- Questionnaire of functional status: use of affected arm, ambulation, assistive device, orthotic, frequency of spasms.
- Evaluation of motor status using the Motor Components of the NIH Stroke Scale (items 4 - 7)
- Dietary history
1. DEXA evaluation. Specific measurements will be made for lumbar spine, hip and distal radius; lateral vertebral assessment will be obtained if possible.
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.
|Study Type :||Observational|
|Actual Enrollment :||87 participants|
|Official Title:||Bone Loss, Fractures, and Management of Bone Health in People With Stroke in Managed Rehabilitation Settings|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00462683
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Rehabilitation Institute of Chicago|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Thomas J Schnitzer, MD, PhD||Northwestern Univesity & Rehabilitation Institute of Chicago|
|Principal Investigator:||Richard Harvey, MD, PhD||Shirley Ryan AbilityLab|
|Principal Investigator:||Elliot Roth, MD||Shirley Ryan AbilityLab|