Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT02997033
Eligibility Criteria:
Inclusion Criteria:
* Full participation in the first SIBLOS study
* Informed consent
Exclusion Criteria:
* Unwillingness or inability to participate
* Medication or disease known to affect bone metabolism, body composition and/or sex steroid metabolism:
* malignancy (previous or current)
* systemic diseases (auto-immune and rheumatoid pathology, ankylosing spondylitis)
* previous or current systemic use of glucocorticoids for more than 3 months, irrespective or dose
* use of glucocorticoid injections in previous 3 months
* use of inhalation glucocorticoids more than 500 µg / day
* previous or current thyroxin therapy (Graves disease, thyroidectomy)
* current insulin use for diabetes mellitus
* previous or current (anti-) androgen treatment or treated hypogonadism
* previous or current anti-epileptic drugs (phenytoin, valproate, carbamazepine, oxcarbazepine/carbamazepine, primidone)
* previous or current hyperthyroidism
* previous or current hyperparathyroidism or serum calcaemia \< 8.5 or \> 11 mg/dL
* hypocalcaemia (corrected for albumin, confirmed in 2 measurements)
* cystic fibrosis
* orchidectomy irrespective of underlying cause
* history of immobilisation \> 3 months or immobilisation \> 4 weeks within previous 6 months
* previous or current history of eating disorder
* serum creatinine \> 2 mg% (estimated creatinine clearance \< 35 mL/min)
* known diseases affecting growth, collagen, bone development or body composition (OI, otosclerosis, AIDS, ...)
* previous or current gastrointestinal malabsorption (gastrectomy, Crohn's disease, ulcerative colitis, coeliac disease, haemochromatosis)
* alcoholism (\> 42 units per week)
* organ transplant recipients
* previous or current treatment for osteoporosis
* previous treatment for cryptorchidism irrespective of age
* current varicocoele or treatment for varicocoele after the age of 25 years (no exclusion if testosterone level in blood is normal)
* BMI \> 42.3 kg/m²
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
25 Years
Study:
NCT02997033
Study Brief:
Protocol Section:
NCT02997033