Complication Of Osteoporosis in Spinal cord injury

• Conditions: 10041543; low bone density; Paraplegia; 10021112; 10017322

• Registration Number: NL-OMON30685
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

- Male or female persons with spinal cord injury
- Age from 18 to 70 years
- SCI since > 1 year

Exclusion Criteria

- Inability to give informed consent

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Absolute and relative number of patients with diagnosis of osteoporosis<br /><br>according to<br /><br>a. WHO criteria: T-score lower or equal than -2.5<br /><br>b. BMD at the femoral neck of 0.577 g/cm2 or less.<br /><br><br /><br>2. Absolute and relative number of patients with diagnosis of osteopenia<br /><br>according to WHO criteria: T-score lower or equal than -1.0 and higher than *2.5<br /><br><br /><br>3. Absolute and relative number of patients with fractures after the onset of<br /><br>SCI.<br /><br><br /><br>4. Absolute and relative number of patients with adequate treatment for<br /><br>osteoporosis or osteopenia with fractures.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>5. Proportion of patients with high bone turnover.<br /><br><br /><br>6. Total Qol-score.<br /><br><br /><br>7. Proportion of patients with endocrine disturbances.<br /><br><br /><br>8. Proportion of patients with autonomic dysregulation.</p><br>