Bone Strength After Spinal Cord Injury

Completed

• Conditions: Spinal Cord Injury
• Interventions: Radiation: DXA; Radiation: pQCT

• Registration Number: NCT01853488
• Lead Sponsor: Swiss Paraplegic Research, Nottwil

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2013-05-02
• Study First Submitted QC: 2013-05-10
• Study First Posted: 2013-05-15
• Status Verified: 2015-11
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Last Update Submitted: 2024-02-09
• Last Update Posted: 2024-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 273

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Spinal Cord Injury	pQCT	Persons with spinal cord injury Osteodensitometry DXA pQCT
Spinal Cord Injury	DXA	Persons with spinal cord injury Osteodensitometry DXA pQCT
Reference	DXA	Reference population (able-bodied) Osteodensitometry DXA pQCT
Reference	pQCT	Reference population (able-bodied) Osteodensitometry DXA pQCT

Primary Outcome Measures

Name	Time	Method
Bone parameters	just one timepoint	Measurement of the extremities with DEXA and pQCT

Secondary Outcome Measures

Name	Time	Method
Fractures	just one timepoint (questionnaire)	Number of fractures since SCI

Trial Locations

Locations (1)

Swiss Paraplegic-Centre; 🇨🇭 Nottwil, Lucerne, Switzerland