Bone Strength After Spinal Cord Injury

NCT ID: NCT01853488

Last Updated: 2024-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

273 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2015-11-30

Brief Summary

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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

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Conditions

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Spinal Cord Injury

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Spinal Cord Injury

Persons with spinal cord injury Osteodensitometry DXA pQCT

DXA

Intervention Type RADIATION

Osteodensitometry

pQCT

Intervention Type RADIATION

Osteodensitometry

Reference

Reference population (able-bodied) Osteodensitometry DXA pQCT

DXA

Intervention Type RADIATION

Osteodensitometry

pQCT

Intervention Type RADIATION

Osteodensitometry

Interventions

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DXA

Osteodensitometry

Intervention Type RADIATION

pQCT

Osteodensitometry

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Spinal Cord Injury
* mobilized patients
* written informed consent

Exclusion Criteria

* current fracture
* limited mobility
* contractures of the lower limbs
* decubitus ulcer
* pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Swiss Paraplegic Research, Nottwil

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Angela Frotzler, PhD

Role: PRINCIPAL_INVESTIGATOR

Swiss Paraplegic Research, Nottwil

Locations

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Swiss Paraplegic-Centre

Nottwil, Canton of Lucerne, Switzerland

Site Status

Countries

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Switzerland

Related Links

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http://www.paranet.ch/en/pub/pan.htm

Swiss Paraplegic Centre Nottwil

Other Identifiers

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2010-13

Identifier Type: -

Identifier Source: org_study_id

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