StrokeNCT00462683
Bone Loss, Fractures, and Management of Bone Health in People With Stroke in Managed Rehabilitation Settings
An observational study of Stroke and Anoxia, run by Northwestern University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Anoxia, Brain Injury
- How many people
- 87 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2007to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who have experienced brain injury.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern University
Chicago, Illinois, 60611
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611
About this study
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.
Read the 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 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:
- DEXA evaluation. Specific measurements will be made for lumbar spine, hip and distal radius; lateral vertebral assessment will be obtained if possible.
Biological Samples:
- 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.
- Conditions
- Stroke, Anoxia, Brain Injury
- Keywords
- Stroke, Anoxia, Brain Injury, Rehabilitation, Osteoporosis, Osteopenia
- Medical subject headings
- Stroke, Hypoxia, Brain Injuries, Osteoporosis, Bone Diseases, Metabolic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2007 (estimated)
- Study startJul 2007
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Shirley Ryan AbilityLab
- Responsible party
- Principal investigator, Thomas J. Schnitzer, Northwestern University
- Investigators
- Thomas J Schnitzer, MD, PhD, Principal investigator, Northwestern Univesity & Rehabilitation Institute of ChicagoRichard Harvey, MD, PhD, Principal investigator, Shirley Ryan AbilityLabElliot Roth, MD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00462683
- Sponsor's protocol ID
- NURIC0445100
- Status last verified
- Jan 2012
- First submitted
- 18 Apr 2007
- Last updated
- 6 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Loss, Fractures, and Management of Bone Health in People With Stroke in Managed Rehabilitation Settings
- ClinicalTrials.gov ID
- NCT00462683
- Acronym / sponsor ID
- NURIC0445100
- Conditions
- Stroke, Anoxia, Brain Injury
- Keywords
- Stroke, Anoxia, Brain Injury, Rehabilitation, Osteoporosis, Osteopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Shirley Ryan AbilityLab
- Study start
- Jul 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 19 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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:
- DEXA evaluation. Specific measurements will be made for lumbar spine, hip and distal radius; lateral vertebral assessment will be obtained if possible.
Biological Samples:
- 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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who have experienced brain injury.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas J Schnitzer, MD, PhD principal investigator
Northwestern Univesity & Rehabilitation Institute of Chicago
Richard Harvey, MD, PhD principal investigator
Shirley Ryan AbilityLab
Elliot Roth, MD principal investigator
Shirley Ryan AbilityLab
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Anoxia, run by Northwestern University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2012.