This study aims to gain insight into the effect of inflammatory factors on bone metabolism. For this purpose we formulated the following research questions:1. Which circulating inflammatory factors play a central role in the pathogenesis of general…
ID
Source
Brief title
Condition
- Gastrointestinal infections
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
osteoblast proliferation, osteoblast differentiation, osteoclastogenesis,
osteoclast function and bone histomorphometry
Secondary outcome
NA
Background summary
Decreased bone mineral density (BMD) is a common phenomenon in chronic
inflammatory diseases like inflammatory bowel disease (IBD), and the prevalence
of osteoporosis complicating these diseases has truly been underestimated. The
pathogenesis of bone loss and osteoporosis in patients with chronic
inflammatory diseases is complex. Traditionally, IBD involves calcium and
vitamin D malabsorption caused by decreased ileal function and corticosteroid
treatment. More recently, the inflammatory process has been proposed to play a
central role in both local and systemic bone loss. However, the exact effect of
inflammation on bone loss still remains unclear.
Study objective
This study aims to gain insight into the effect of inflammatory factors on bone
metabolism. For this purpose we formulated the following research questions:
1. Which circulating inflammatory factors play a central role in the
pathogenesis of general and local osteoporosis in patients with chronic
inflammatory diseases?
2. Can the pathogenesis of general and local osteoporosis be inhibited by
blocking specific inflammatory factors, comparable to the inhibition of TNF
alpha by infliximab?
3. Is there a difference in the osteoclastogenesis and/or osteoclast function
between patients with chronic inflammatory diseases and healthy controls?
Study design
cross-sectional
Study burden and risks
A transiliac bone biopsy may involve pain and discomfort. There is some risk of
bruising and wound infection, but serious complications are very rare. The
drawing of a blood sample may involve some discomfort.
De Boelelaan 1117
1081 GH
NL
De Boelelaan 1117
1081 GH
NL
Listed location countries
Age
Inclusion criteria
1. Men and women between the age of 18 and 50 years
2. Informed consent
3a. Patients suffering from Crohn*s disease of at least 3 months duration, confirmed by
radiography, endoscopy and histology (according to the Lennard-Jones criteria ; Lennard-Jones 1989).
3b. Patients suffering from Ulcerative Colitis of at least 3 months duration, confirmed by
radiography, endoscopy and histology (according to the Lennard-Jones criteria)
4. a BMI between 18-30
Exclusion criteria
1. Co-morbidity influencing bone metabolism
- Renal insufficiency (creatinin clearance < 40 ml/min)
- untreated hypo- / hyperthyroidism (stabily treated hypothyroidism may be included)
- Paget*s disease or other metabolic bone diseases, Cushing*s disease or hyperprolactinemia
2. Patients who have received calcitonin, bisphosphonates and strontium within 1 year
3. Use of corticosteroids current use and in the last 3 months in case of longterm use or in the last 6 weeks in case of induction therapy
4. Patients who have been treated with anti-TNF in the last 6 months
5. Use of antitrombotic agents
6. Patients who are pregnant, breast-feeding or menopausal
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 | NL23103.029.08 |