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Bone Strength After Spinal Cord Injury

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01853488
First Posted: May 15, 2013
Last Update Posted: November 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Clinical Trial Unit, Swiss Paraplegic Centre Nottwil
  Purpose

Background:

After a traumatic spinal cord injury, a severe bone loss in the paralyzed extremities is observed. This leads to a osteoporosis which is connected to a high fracture risk.

Aims:

To compare the two measurement methods DEXA and pQCT concerning optimal diagnostics and assessment of fracture risk in subjects with spinal cord injury.

Subjects:

250 women and 250 men (age≥18, any AIS-classification) with an acute or chronic spinal cord injury will be recruited for this study. For a reference group, 500 able-bodied persons will be measured analogously.

Methods:

Using DEXA-Osteodensitometry, bone parameters of the lumbar vertebral column, proximal femur, distal radius, distal tibia and knee area will be assessed. Additionally, geometric bone parameters of the tibia will be measured by using pQCT. All measurements will be done unilaterally. For the assessment of potential risk factors for reduced bone stiffness after spinal cord injury a questionnaire will be used.


Condition Intervention
Spinal Cord Injury Radiation: DXA Radiation: pQCT

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Impact of Spinal Cord Injury on Bone Strength in Paralysed Extremities.

Resource links provided by NLM:


Further study details as provided by Clinical Trial Unit, Swiss Paraplegic Centre Nottwil:

Primary Outcome Measures:
  • Bone parameters [ Time Frame: just one timepoint ]
    Measurement of the extremities with DEXA and pQCT


Secondary Outcome Measures:
  • Fractures [ Time Frame: just one timepoint (questionnaire) ]
    Number of fractures since SCI


Enrollment: 273
Study Start Date: October 2010
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Spinal Cord Injury
Persons with spinal cord injury Osteodensitometry DXA pQCT
Radiation: DXA
Osteodensitometry
Radiation: pQCT
Osteodensitometry
Reference
Reference population (able-bodied) Osteodensitometry DXA pQCT
Radiation: DXA
Osteodensitometry
Radiation: pQCT
Osteodensitometry

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients of the Swiss Paraplegic Centre Nottwil (in-patient or out-patient).
Criteria

Inclusion Criteria:

  • Spinal Cord Injury
  • mobilized patients
  • written informed consent

Exclusion Criteria:

  • current fracture
  • limited mobility
  • contractures of the lower limbs
  • decubitus ulcer
  • pregnancy
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01853488


Locations
Switzerland
Swiss Paraplegic-Centre
Nottwil, Lucerne, Switzerland, 6207
Sponsors and Collaborators
Swiss Paraplegic Centre Nottwil
Investigators
Principal Investigator: Angela Frotzler, PhD Swiss Paraplegic Centre Nottwil
  More Information

Additional Information:
Responsible Party: Clinical Trial Unit, Angela Frotzler, PhD, Swiss Paraplegic Centre Nottwil
ClinicalTrials.gov Identifier: NCT01853488     History of Changes
Other Study ID Numbers: 2010‐13
First Submitted: May 2, 2013
First Posted: May 15, 2013
Last Update Posted: November 26, 2015
Last Verified: November 2015

Keywords provided by Clinical Trial Unit, Swiss Paraplegic Centre Nottwil:
Osteoporosis
BMD
SCI
DXA
pQCT

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System