- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00462683
Bone Loss, Fractures, and Management of Bone Health in People With Stroke in Managed Rehabilitation Settings
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
Illinois
-
Chicago, Illinois, Förenta staterna, 60611
- Northwestern University
-
Chicago, Illinois, Förenta staterna, 60611
- Rehabilitation Institute of Chicago
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- History of brain injury at some defined time in the past (include stroke, traumatic brain injury, anoxia)
- Age 16 years and older (no upper age limit)
- Male and females
- Able to undergo a DEXA examination (able to lie on the DEXA table for 20-30 minutes)
- Able to provide answers to the questionnaires regarding medical and dietary history and demographics
- Able to provide informed consent
Exclusion Criteria:
- History of spinal cord injury
- History of traumatic brain damage
- Inability to lie down appropriately to obtain DEXA measurements
- Inability to communicate
- Anything condition that in the judgment of the physician would prevent the person from participating
Studieplan
Hur är studien utformad?
Designdetaljer
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Thomas J Schnitzer, MD, PhD, Northwestern Univesity & Rehabilitation Institute of Chicago
- Huvudutredare: Richard Harvey, MD, PhD, Shirley Ryan AbilityLab
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- NURIC0445100
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .