Bone Strength After Spinal Cord Injury

NCT01853488 | Completed

• 1 other identifier: 2010-13
• Study Type: observational
• Target: 273
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Keywords

Osteoporosis; BMD; SCI; DXA; pQCT

Outcome Measures

Primary Outcomes (1)

• Bone parameters

  Measurement of the extremities with DEXA and pQCT

  just one timepoint

Secondary Outcomes (1)

• Fractures

  just one timepoint (questionnaire)

Study Arms (2)

Spinal Cord Injury

Persons with spinal cord injury Osteodensitometry DXA pQCT

Radiation: DXA; Radiation: pQCT

Reference

Reference population (able-bodied) Osteodensitometry DXA pQCT

Radiation: DXA; Radiation: pQCT

Interventions

DXA RADIATION

Osteodensitometry

Reference; Spinal Cord Injury

pQCT RADIATION

Osteodensitometry

Reference; Spinal Cord Injury

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Spinal Cord Injury
• mobilized patients
• written informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Swiss Paraplegic Research, Nottwil: lead

Study Sites (1)

Swiss Paraplegic-Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

Related Links

• Swiss Paraplegic Centre Nottwil

MeSH Terms

Conditions

Spinal Cord Injuries; Osteoporosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Angela Frotzler, PhD

  Swiss Paraplegic Research, Nottwil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2013
• First Posted: May 15, 2013
• Study Start: October 1, 2010
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: February 13, 2024

Record last verified: 2015-11

Locations

CH (1)