Bone Strength After Spinal Cord Injury

February 9, 2024 updated by: Swiss Paraplegic Research, Nottwil

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

273

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Lucerne
      • Nottwil, Lucerne, Switzerland, 6207
        • Swiss Paraplegic-Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients of the Swiss Paraplegic Centre Nottwil (in-patient or out-patient).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Spinal Cord Injury
Persons with spinal cord injury Osteodensitometry DXA pQCT
Radiation: DXA
Osteodensitometry
Radiation: pQCT
Osteodensitometry
Reference
Reference population (able-bodied) Osteodensitometry DXA pQCT
Radiation: DXA
Osteodensitometry
Radiation: pQCT
Osteodensitometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone parameters
Time Frame: just one timepoint
Measurement of the extremities with DEXA and pQCT
just one timepoint

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fractures
Time Frame: just one timepoint (questionnaire)
Number of fractures since SCI
just one timepoint (questionnaire)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Paraplegic Research, Nottwil

Investigators

  • Principal Investigator: Angela Frotzler, PhD, Swiss Paraplegic Research, Nottwil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

May 2, 2013

First Submitted That Met QC Criteria

May 10, 2013

First Posted (Estimated)

May 15, 2013

Study Record Updates

Last Update Posted (Actual)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 9, 2024

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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