Clinical trial · Observational
SIBlos EXtension Study (SIBEX)
Longitudinal Extension Phase of Sibling Pair Linkage Analysis of Bone Mineral Density / Geometry and Sex Steroid and Thyroid Status in Healthy Young Men
NCT02997033CI-TRIAL-00063742completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Population-based, longitudinal cohort study designed to evaluate changes in bone mineral density, bone geometry, body composition, parameters reflecting muscle force, and sex steroid status in healthy young men, as well as their interactions, over a period of +-10 years.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Density | — | UNRESOLVED | — |
| Gonadal Steroid Hormones | — | UNRESOLVED | — |
| Thyroid Hormones | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Total study cohort
- interventionNames
- Other: No intervention
Primary outcomes (1)
- measure
- Change in bone mineral density
- timeFrame
- ten years
- description
- Change in bone mineral density vs. baseline (= study visit in SIBLOS study)
Secondary outcomes (2)
- measure
- Change in sex steroid levels
- timeFrame
- ten years
- description
- Change in sex steroid levels vs. baseline (= study visit in SIBLOS study)
- measure
- Change in body composition
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 25 Years
Show eligibility criteria text
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
References
Publications (23)
- BACKGROUNDKaptoge S, da Silva JA, Brixen K, Reid DM, Kroger H, Nielsen TL, Andersen M, Hagen C, Lorenc R, Boonen S, de Vernejoul MC, Stepan JJ, Adams J, Kaufman JM, Reeve J. Geographical variation in DXA bone mineral density in young European men and women. Results from the Network in Europe on Male Osteoporosis (NEMO) study. Bone. 2008 Aug;43(2):332-339. doi: 10.1016/j.bone.2008.04.001. Epub 2008 Apr 16. PMID 18519175
- BACKGROUNDBogaert V, Taes Y, Konings P, Van Steen K, De Bacquer D, Goemaere S, Zmierczak H, Crabbe P, Kaufman JM. Heritability of blood concentrations of sex-steroids in relation to body composition in young adult male siblings. Clin Endocrinol (Oxf). 2008 Jul;69(1):129-35. doi: 10.1111/j.1365-2265.2008.03173.x. PMID 18598274
- BACKGROUNDLapauw BM, Taes Y, Bogaert V, Vanbillemont G, Goemaere S, Zmierczak HG, De Bacquer D, Kaufman JM. Serum estradiol is associated with volumetric BMD and modulates the impact of physical activity on bone size at the age of peak bone mass: a study in healthy male siblings. J Bone Miner Res. 2009 Jun;24(6):1075-85. doi: 10.1359/jbmr.081260. PMID 19113912
- BACKGROUNDVanbillemont G, Bogaert V, De Bacquer D, Lapauw B, Goemaere S, Toye K, Van Steen K, Taes Y, Kaufman JM. Polymorphisms of the SHBG gene contribute to the interindividual variation of sex steroid hormone blood levels in young, middle-aged and elderly men. Clin Endocrinol (Oxf). 2009 Feb;70(2):303-10. doi: 10.1111/j.1365-2265.2008.03365.x. Epub 2008 Aug 4. PMID 18681858
- BACKGROUNDBogaert V, Vanbillemont G, Taes Y, De Bacquer D, Deschepper E, Van Steen K, Kaufman JM. Small effect of the androgen receptor gene GGN repeat polymorphism on serum testosterone levels in healthy men. Eur J Endocrinol. 2009 Jul;161(1):171-7. doi: 10.1530/EJE-09-0123. Epub 2009 Apr 21. PMID 19383805
- BACKGROUNDTaes YE, Lapauw B, Vanbillemont G, Bogaert V, De Bacquer D, Zmierczak H, Goemaere S, Kaufman JM. Fat mass is negatively associated with cortical bone size in young healthy male siblings. J Clin Endocrinol Metab. 2009 Jul;94(7):2325-31. doi: 10.1210/jc.2008-2501. Epub 2009 Apr 28.