Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00462683
Status:
COMPLETED
Last Update Posted:
2012-01-06
First Post:
2007-04-18
Brief Title:
Bone Loss Fractures and Management of Bone Health in People With Stroke in Managed Rehabilitation Settings
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Bone Loss Fractures and Management of Bone Health in People With Stroke in Managed Rehabilitation Settings
Status:
COMPLETED
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 eg forearms hips spine will be determined as will specific interventions eg 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 strengthfunction and to compare this data with bone-focused information such as bone mineral density BMD falls and history
Detailed Description:
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 andor 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
1 Demographics date of birth sex race ethnicity
2 Detailed and complete medical history with particular focus on
Information regarding brain injury time of occurrence motorsensory 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
3 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 andor bone markers
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 andor 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
1 Demographics date of birth sex race ethnicity
2 Detailed and complete medical history with particular focus on
Information regarding brain injury time of occurrence motorsensory 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
3 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 andor bone markers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None