|- candidate number||2916|
|- NTR Number||NTR1145|
|- ISRCTN||ISRCTN wordt niet aangevraagd/Observational study|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||27-nov-2007|
|- Secondary IDs||protocol ID/number 2007/006 VU University Medical Center|
|- Public Title||Observational study;|
Osteoporosis in spinal cord injury patients.
|- Scientific Title||Observational study;|
Complication Of Osteoporosis in Spinal cord injury study.
|- hypothesis||Osteoporosis is common in patients with SCI and often causes fractures and is undertreated. |
Besides immobilization, other (endocrine) disturbances such as hypogonadism and/or growthhormone deficiency, which are seen after SCI with accompanying Traumatic Brain Injury (TBI) might also aggravate loss of BMD. Also, The decentralized autonomic nervous system with periodic high sympathetic activity (often seen in SCI patients), might be related to the frequency of occurrence and severity of osteoporosis.
|- Healt Condition(s) or Problem(s) studied||Spinal Cord Injury|
|- Inclusion criteria||1. Wheelchair-bound male or female persons with spinal cord injury;|
2. Age from 18 to 70 years;
3. SCI since > 1 year.
|- Exclusion criteria||Inability to give informed consent.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-okt-2007|
|- planned closingdate||1-jan-2010|
|- Target number of participants||80|
|- Interventions||None. Observational study in 40 spinal cord injury patients and 40 healthy controls.|
|- Primary outcome||1. Absolute and relative number of patients with diagnosis of osteoporosis or osteopenia according to WHO criteria;|
2. Proportion of participants with a Z-score of -1.0 or lower;
3. Absolute and relative number of patients with fractures after the onset of SCI and the proportion that is adequately treated.
|- Secondary outcome||1. Proportion of patients with high bone turnover;|
2. Total Qol-score;
3. Proportion of patients with endocrine disturbances and/or autonomic dysregulation.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| B.L.J Kanen|
|- CONTACT for SCIENTIFIC QUERIES|| B.L.J Kanen|
|- Sponsor/Initiator ||VU University Medical Center, Department of Endocrinology|
(Source(s) of Monetary or Material Support)
|VU University Medical Center, Department of Pediatric Endocrinology|
|- Brief summary||Spinal cord injury (SCI) is a major risk factor for osteoporosis due to immobilization. Limited data suggest that osteoporosis has a prevalence of approximately 60-80% in men with SCI and fractures occur in 20 to 35% of patients. Despite this high prevalence, patients are not usually analyzed for the presence of osteoporosis and data on prevalence and incidence of osteoporosis and fractures are limited and although bisphosphonates have been shown to be effective in reducing bone loss after acute SCI, chronic SCI is not seen as an indication for secondary prevention with antiosteoporotic medication.|
This study aims to determine prevalence of osteoporosis, fractures and active treatment in patients with SCI since more than 1 year. Also we will investigate other possible pathophysiologic processes as accompanying traumatic brain injury or autonomic dysfunction, that might contribute to the high bone loss in SCI.
It is a 2-year monocenter, cross sectional observational study in which 40 wheelchair-bound patients with traumatic SCI since more than 1 year and 40 healthy controls will be investigated for osteoporosis according to WHO-criteria. Data regarding fractures, quality of life, level, completeness and duration of SCI will be collected. In case of traumatic brain injury pituitary hormone levels will be measured. Autonomic (dys)function will be investigated. After completion of the study, participants will receive a treatment advice.
|- Main changes (audit trail)|
|- RECORD||27-nov-2007 - 12-nov-2008|