Determination of possible risk factors for developing osteoporosis in GOLD II COPD patients.
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Determination of possible risk factors for the developing of osteoporosis in
COPD GOLD II patients.
Bone mineral density (T-score and Z-score): osteoporosis vs no osteoporosis
• BMI/VVMI
• Emfysema/chronic bronchitis (HRCT scan and diffusion capacity)
• Hyperinflation
• Physical capacity
• Nutritional status
• Infectious parameters (CRP, ESR, leucocytes)
• Use of medication
Secondary outcome
Not applicable
Background summary
Osteoporosis is characterized by low bone mass and a changed micro architecture
leading to increased bone fragility and an increased fracture risk. The
etiology of osteoporosis in COPD patients is complex and multifactorial. There
are not mana large studies investigating the causes of osteoporosis in COPD
patients. Most of the studies investigate patients with more serious COPD.
Study objective
Determination of possible risk factors for developing osteoporosis in GOLD II
COPD patients.
Study design
A case control study. Patients with COPD GOLD II (diagnosis according to ATS
guidelines and devided according to GOLD-classification) who participated in
the study "osteoporosis in COPD patients" or who visit the outpatients clinic
of pulmonology of the Catharina Hospital Eindhoven will be asked to
participate. Patients will answer the questionnaire, do a 6-minute walking
distance, will have a bio-impedance measurement, will get a blood test, an
X-ray of the vertebrae, a HRCT and a DEXA-scan (or the previously collected
data will be used)
Patients with osteoporosis will be matched with patients without osteoporosis
(matched by age and gender). By univariate and myltivariate analyses the
collected data will be analysed to determine possible risk factors for the
development of osteoporosis in COPD GOLD II patients.
Study burden and risks
Patients will need to come to the hospital once or twice for a six minute
walking distance, bio-impedance measurement, X-ray of the spine, to draw some
blood and to have a High resolution CT made. Also they will have to go to the
Diagnostic Centrum Einhoven to have a DEXA-scan made.
So the burden is relatively low and also the risks associated with drawing
blood and having a CT-scan and DEXA-scan taken are low.
For some patients the tests are already done so the burden and risk will be
none.
Michelangelolaan 2
5623 EJ Eindhoven
Nederland
Michelangelolaan 2
5623 EJ Eindhoven
Nederland
Listed location countries
Age
Inclusion criteria
Age >=40
COPD GOLD II patients
Written permission (informed consent)
Men and women
Exclusion criteria
Age < 40
COPD GOLD I, III or IV
No permission
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 | NL18223.060.07 |