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NCT01853488 Clinical Trial

Bone Strength After Spinal Cord Injury

Spinal Cord Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01853488
Other study ID # 2010-13
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2010
Est. completion date November 2015

Study information
Verified date November 2015
Source Swiss Paraplegic Research, Nottwil
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 (ageā‰„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.

Recruitment information / eligibility
Status Completed
Enrollment 273
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Spinal Cord Injury - mobilized patients - written informed consent Exclusion Criteria: - current fracture - limited mobility - contractures of the lower limbs - decubitus ulcer - pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• DXA
Osteodensitometry
• pQCT
Osteodensitometry

Locations
Country Name City State
Switzerland Swiss Paraplegic-Centre Nottwil Lucerne

Sponsors (1)
Lead Sponsor Collaborator
Swiss Paraplegic Research, Nottwil

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Bone parameters Measurement of the extremities with DEXA and pQCT just one timepoint
Secondary Fractures Number of fractures since SCI just one timepoint (questionnaire)
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