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
• Status: Completed
• 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
• 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 (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.

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

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)

External Links

•   Swiss Paraplegic Centre Nottwil