Bone Loss, Fractures, and Management of Bone Health in People With Stroke in Managed Rehabilitation Settings

NCT00462683 | Completed

• 1 other identifier: NURIC0445100
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 2

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 (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.

Conditions

Stroke; Anoxia; Brain Injury

Keywords

Stroke; Anoxia; Brain Injury; Rehabilitation; Osteoporosis; Osteopenia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who have experienced brain injury.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• Shirley Ryan AbilityLab: collaborator

Study Sites (2)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

MeSH Terms

Conditions

Stroke; Hypoxia; Brain Injuries; Osteoporosis; Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 18, 2007
• First Posted: April 19, 2007
• Study Start: July 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 6, 2012

Record last verified: 2012-01

Locations

US (2)