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Bone Strength After Spinal Cord Injury

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. Identifier: NCT01853488
Recruitment Status : Completed
First Posted : May 15, 2013
Last Update Posted : November 26, 2015
Information provided by (Responsible Party):
Clinical Trial Unit, Swiss Paraplegic Centre Nottwil

Brief Summary:


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.


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


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.


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 or disease Intervention/treatment
Spinal Cord Injury Radiation: DXA Radiation: pQCT

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Study Type : Observational
Actual Enrollment : 273 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Impact of Spinal Cord Injury on Bone Strength in Paralysed Extremities.
Study Start Date : October 2010
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Spinal Cord Injury
Persons with spinal cord injury Osteodensitometry DXA pQCT
Radiation: DXA

Radiation: pQCT

Reference population (able-bodied) Osteodensitometry DXA pQCT
Radiation: DXA

Radiation: pQCT

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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).

Inclusion Criteria:

  • Spinal Cord Injury
  • mobilized patients
  • written informed consent

Exclusion Criteria:

  • current fracture
  • limited mobility
  • contractures of the lower limbs
  • decubitus ulcer
  • pregnancy

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 identifier (NCT number): NCT01853488

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Swiss Paraplegic-Centre
Nottwil, Lucerne, Switzerland, 6207
Sponsors and Collaborators
Swiss Paraplegic Centre Nottwil
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Principal Investigator: Angela Frotzler, PhD Swiss Paraplegic Centre Nottwil
Additional Information:
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Responsible Party: Clinical Trial Unit, Angela Frotzler, PhD, Swiss Paraplegic Centre Nottwil Identifier: NCT01853488    
Other Study ID Numbers: 2010‐13
First Posted: May 15, 2013    Key Record Dates
Last Update Posted: November 26, 2015
Last Verified: November 2015
Keywords provided by Clinical Trial Unit, Swiss Paraplegic Centre Nottwil:
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System