Bone Strength After Spinal Cord Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Swiss Paraplegic Centre Nottwil
Sponsor:
Information provided by (Responsible Party):
Clinical Trial Unit, Swiss Paraplegic Centre Nottwil
ClinicalTrials.gov Identifier:
NCT01853488
First received: May 2, 2013
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Spinal Cord Injury
Radiation: DXA
Radiation: pQCT

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Impact of Spinal Cord Injury on Bone Strength in Paralysed Extremities.

Resource links provided by NLM:


Further study details as provided by Swiss Paraplegic Centre Nottwil:

Primary Outcome Measures:
  • Bone parameters [ Time Frame: just one timepoint ] [ Designated as safety issue: No ]
    Measurement of the extremities with DEXA and pQCT


Secondary Outcome Measures:
  • Fractures [ Time Frame: just one timepoint (questionnaire) ] [ Designated as safety issue: No ]
    Number of fractures since SCI


Estimated Enrollment: 1000
Study Start Date: October 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • Spinal Cord Injury
  • mobilized patients
  • written informed consent

Exclusion Criteria:

  • current fracture
  • limited mobility
  • contractures of the lower limbs
  • decubitus ulcer
  • pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01853488

Locations
Switzerland
Swiss Paraplegic-Centre Recruiting
Nottwil, Lucerne, Switzerland, 6207
Contact: Angela Frotzler, PhD    +41419395561    angela.frotzler@paranet.ch   
Principal Investigator: Angela Frotzler, PhD         
Sponsors and Collaborators
Swiss Paraplegic Centre Nottwil
Investigators
Principal Investigator: Angela Frotzler, PhD Swiss Paraplegic Centre Nottwil
  More Information

Additional Information:
No publications provided

Responsible Party: Clinical Trial Unit, Angela Frotzler, PhD, Swiss Paraplegic Centre Nottwil
ClinicalTrials.gov Identifier: NCT01853488     History of Changes
Other Study ID Numbers: 2010‐13
Study First Received: May 2, 2013
Last Updated: May 13, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by Swiss Paraplegic Centre Nottwil:
Osteoporosis
BMD
SCI
DXA
pQCT

Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 22, 2014