To collect data regarding the prevalence of:I) - osteoporosis in SCI patients and the relation to characteristics of SCI. - fractures in SCI patients and the relation to characteristics of SCI. - active treatment of osteoporosis in SCI patients.II…
ID
Source
Brief title
Condition
- Hypothalamus and pituitary gland disorders
- Fractures
- Spinal cord and nerve root disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Absolute and relative number of patients with diagnosis of osteoporosis
according to
a. WHO criteria: T-score lower or equal than -2.5
b. BMD at the femoral neck of 0.577 g/cm2 or less.
2. Absolute and relative number of patients with diagnosis of osteopenia
according to WHO criteria: T-score lower or equal than -1.0 and higher than *2.5
3. Absolute and relative number of patients with fractures after the onset of
SCI.
4. Absolute and relative number of patients with adequate treatment for
osteoporosis or osteopenia with fractures.
Secondary outcome
5. Proportion of patients with high bone turnover.
6. Total Qol-score.
7. Proportion of patients with endocrine disturbances.
8. Proportion of patients with autonomic dysregulation.
Background summary
The Netherlands has approximately 16.000 spinal cord injury patients. Spinal
cord injury (SCI) is often associated severe osteoporosis. Osteoporosis has a
prevalence of approximately 60% in men with SCI. Osteopenia is seen in 20% and
fractures occur in 20 to 35% of patients. Despite this high prevalence,
patients are not usually analyzed for the presence of osteoporosis. Recent
studies point towards an important role of the autonomic nervous system in the
pathogenesis of osteoporosis and this might be of extra interest and importance
in SCI patients. Endocrine disturbances as seen in traumatic brain injury might
be a contributing factor when also present. Most importantly, there are no
guidelines for diagnosis and treatment of osteoporosis in SCI patients.
Hypothesis:
A) Osteoporosis is common in patients with SCI and often causes fractures.
B) Osteoporosis in patients with SCI is undertreated.
C) Besides immobilization, other (endocrine) disturbances such as hypogonadism
and/or growth hormone deficiency, which are seen after SCI with accompanying
Traumatic Brain Injury (TBI) might also aggravate loss of BMD.
D) SCI results in an increased loss of BMD of more than 1 SD compared to the
normal population.
E) 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. In line with this we hypothesize that
anti-beta-adrenergic blockade might be protective.
Study objective
To collect data regarding the prevalence of:
I) - osteoporosis in SCI patients and the relation to characteristics of SCI.
- fractures in SCI patients and the relation to characteristics
of SCI.
- active treatment of osteoporosis in SCI patients.
II) - hormonal abnormalities (as seen in TBI) in SCI patients.
To compare:
III) - BMD of SCI patients to BMD of control groups:
> BMD of brother, sister or partner of SCI patient.
> AGGO-database (ages: between 30-42 years old).
> LASA-database (ages: 55 years or older).
To investigate a possible relation between:
IV) - the sympathetic and parasympathetic nervous system activity and/or
endocrine disturbances and BMD.
V) - fractures and Quality of Life (QoL).
Study design
Cross sectional, monocenter, single country, observational study.
Study burden and risks
This is an epidemiological study in which patients from the rehabilitation
center are referred to the outpatients clinic of the department of
endocrinology of the VU University Medical Center for an intake and physical
examination (including blood pressure while, lying, sitting and when possible
standing), blood and urine investigations. Also, a total body, lumbar and
femoral bone mineral density measurement (DXA) will be done, combined with an
Instant Vertebral Assessment (IVA) for diagnosis vertebral fractures. If
indicatid, conventional X-rays can be done of specifeid skeletal parts.
Radiation dosages of DXA/IVA are very low. Heart rate-variance will be measured
with a 24 hour ambulant recording. These investigations will take 3 visits
after which a treatment advice is given.
De Boelelaan 1117
1081 HV Amsterdam
NL
De Boelelaan 1117
1081 HV Amsterdam
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL15360.029.06 |