The Effect of Gaucher Disease on Bone Cells
- Conditions
- 1000533010005959Gaucher disease
- Registration Number
- NL-OMON34135
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Patients
1. Men and women between the age of 18 and 65 years
2. Informed consent
3. Patient with a proven diagnosis of Gaucher disease
4. Stable (< 5% change) body weight for at least 6 months and a BMI between 18-30;healthy controls
1. Men and women between the age of 18 and 65 years
2. Informed consent
3. Stable (< 5% change) body weight for at least 6 months and a BMI between 18-30
Patients and healthy controls:
1. Documented inflammatory or malignant bowel disease
2. Previous bowel surgery, both small intestine and/or colon, with the exception of appendicular surgery.
3. Cholestatic disease defined by elevated values of AP or gammaGT > 2 x upper reference limit
4. Fever of unknown cause during the past 4 weeks prior to study
5. 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
6. Patients who have received calcitonin, bisphosphonates and strontium within 1 year
7. 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
8. Patients who have been treated with anti-TNF in the last 6 months
9. Use of antitrombotic agents
10. Patients who are pregnant or breast-feeding
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>osteoblast proliferation, osteoblast differentiation, osteoclastogenesis,<br /><br>osteoclast function</p><br>
- Secondary Outcome Measures
Name Time Method <p>na</p><br>