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Clinical Trials/NCT01853488
NCT01853488
Completed
Not Applicable

Impact of Spinal Cord Injury on Bone Strength in Paralysed Extremities.

Swiss Paraplegic Research, Nottwil1 site in 1 country273 target enrollmentOctober 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinal Cord Injury
Sponsor
Swiss Paraplegic Research, Nottwil
Enrollment
273
Locations
1
Primary Endpoint
Bone parameters
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 2010
End Date
November 2015
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Swiss Paraplegic Research, Nottwil
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Bone parameters

Time Frame: just one timepoint

Measurement of the extremities with DEXA and pQCT

Secondary Outcomes

  • Fractures(just one timepoint (questionnaire))

Study Sites (1)

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