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Completed

NCT Number: NCT01853488

Bone Strength After Spinal Cord Injury

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.

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Key information

Conditions

Spinal Cord Injury Bone Diseases Bone Diseases, Metabolic Central Nervous System Diseases Metabolic Diseases Musculoskeletal Diseases Nervous System Diseases Nutritional and Metabolic Diseases Osteoporosis Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Swiss Paraplegic-Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Spinal Cord Injury
  • mobilized patients
  • written informed consent

Exclusion criteria

  • current fracture
  • limited mobility
  • contractures of the lower limbs
  • decubitus ulcer
  • pregnancy

Treatment and study plan

DXA

Radiation

Osteodensitometry

pQCT

Radiation

Osteodensitometry

Primary outcomes

  1. Bone parameters

    Time frame: just one timepoint

    Measurement of the extremities with DEXA and pQCT

Secondary outcomes

  1. Fractures

    Time frame: just one timepoint (questionnaire)

    Number of fractures since SCI

Sponsors and collaborators

Lead sponsor

Swiss Paraplegic Research, Nottwil

Network

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
May 15, 2013
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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