SIBlos EXtension Study (SIBEX)

NCT02997033 | Completed

• 1 other identifier: 2013/1090
• Study Type: observational
• Target: 709
• Locations: 1 country
• Sites: 1

Brief Summary

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

Bone Density; Gonadal Steroid Hormones; Thyroid Hormones

Keywords

Bone; Sex steroids; Body composition; Men

Outcome Measures

Primary Outcomes (1)

• Change in bone mineral density

  Change in bone mineral density vs. baseline (= study visit in SIBLOS study)

  ten years

Secondary Outcomes (2)

• Change in sex steroid levels

  ten years

• Change in body composition

  ten years

Study Arms (1)

Total study cohort

Other: No intervention

Interventions

No intervention OTHER

No intervention

Total study cohort

Eligibility Criteria

• Age: 25 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants of the first SIBLOS study (recruited between 2002 and 2009)

You may qualify if:

• Full participation in the first SIBLOS study
• Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Ghent University Hospital, Dept. of Endocrinology

Ghent, 9000, Belgium

Location

Related Publications (23)

• Kaptoge 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 BACKGROUND

• Bogaert 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 BACKGROUND

• Lapauw 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 BACKGROUND

• Vanbillemont 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 BACKGROUND

• Bogaert 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 BACKGROUND

• Taes 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.

  PMID: 19401374 BACKGROUND

• Taes Y, Lapauw B, Vanbillemont G, Bogaert V, De Bacquer D, Goemaere S, Zmierczak H, Kaufman JM. Early smoking is associated with peak bone mass and prevalent fractures in young, healthy men. J Bone Miner Res. 2010 Feb;25(2):379-87. doi: 10.1359/jbmr.090809.

  PMID: 19653814 BACKGROUND

• Vanbillemont G, Lapauw B, Bogaert V, De Naeyer H, De Bacquer D, Ruige J, Kaufman JM, Taes YE. Birth weight in relation to sex steroid status and body composition in young healthy male siblings. J Clin Endocrinol Metab. 2010 Apr;95(4):1587-94. doi: 10.1210/jc.2009-2149. Epub 2010 Feb 3.

  PMID: 20130068 BACKGROUND

• Taes Y, Lapauw B, Griet V, De Bacquer D, Goemaere S, Zmierczak H, Kaufman JM. Prevalent fractures are related to cortical bone geometry in young healthy men at age of peak bone mass. J Bone Miner Res. 2010 Jun;25(6):1433-40. doi: 10.1002/jbmr.17.

  PMID: 20200932 BACKGROUND

• Vanbillemont G, Lapauw B, Bogaert V, Goemaere S, Zmierczak HG, Taes Y, Kaufman JM. Sex hormone-binding globulin as an independent determinant of cortical bone status in men at the age of peak bone mass. J Clin Endocrinol Metab. 2010 Apr;95(4):1579-86. doi: 10.1210/jc.2009-2189. Epub 2010 Feb 4.

  PMID: 20133463 BACKGROUND

• Roef G, Lapauw B, Goemaere S, Zmierczak H, Fiers T, Kaufman JM, Taes Y. Thyroid hormone status within the physiological range affects bone mass and density in healthy men at the age of peak bone mass. Eur J Endocrinol. 2011 Jun;164(6):1027-34. doi: 10.1530/EJE-10-1113. Epub 2011 Mar 10.

  PMID: 21393448 BACKGROUND

• Vanbillemont G, Lapauw B, De Naeyer H, Roef G, Kaufman JM, Taes YE. Sex hormone-binding globulin at the crossroad of body composition, somatotropic axis and insulin/glucose homeostasis in young healthy men. Clin Endocrinol (Oxf). 2012 Jan;76(1):111-8. doi: 10.1111/j.1365-2265.2011.04155.x.

  PMID: 21711374 BACKGROUND

• Boudin E, Piters E, Fransen E, Nielsen TL, Andersen M, Roef G, Taes Y, Brixen K, Van Hul W. Association study of common variants in the sFRP1 gene region and parameters of bone strength and body composition in two independent healthy Caucasian male cohorts. Mol Genet Metab. 2012 Mar;105(3):508-15. doi: 10.1016/j.ymgme.2011.11.189. Epub 2011 Nov 23.

  PMID: 22178351 BACKGROUND

• Boudin E, Piters E, Nielsen TL, Andersen M, Roef G, Taes Y, Brixen K, Van Hul W. Single nucleotide polymorphisms in sFRP4 are associated with bone and body composition related parameters in Danish but not in Belgian men. Mol Genet Metab. 2012 Jul;106(3):366-74. doi: 10.1016/j.ymgme.2012.04.021. Epub 2012 May 2.

  PMID: 22608881 BACKGROUND

• Roef G, Lapauw B, Goemaere S, Zmierczak HG, Toye K, Kaufman JM, Taes Y. Body composition and metabolic parameters are associated with variation in thyroid hormone levels among euthyroid young men. Eur J Endocrinol. 2012 Nov;167(5):719-26. doi: 10.1530/EJE-12-0447. Epub 2012 Sep 6.

  PMID: 22956557 BACKGROUND

• Van Camp JK, Beckers S, Zegers D, Boudin E, Nielsen TL, Andersen M, Roef G, Taes Y, Brixen K, Van Hul W. Genetic association study of WNT10B polymorphisms with BMD and adiposity parameters in Danish and Belgian males. Endocrine. 2013 Aug;44(1):247-54. doi: 10.1007/s12020-012-9869-7. Epub 2013 Jan 17.

  PMID: 23325361 BACKGROUND

• Roef GL, Rietzschel ER, De Meyer T, Bekaert S, De Buyzere ML, Van daele C, Toye K, Kaufman JM, Taes YE. Associations between single nucleotide polymorphisms in thyroid hormone transporter genes (MCT8, MCT10 and OATP1C1) and circulating thyroid hormones. Clin Chim Acta. 2013 Oct 21;425:227-32. doi: 10.1016/j.cca.2013.08.017. Epub 2013 Aug 24.

  PMID: 23978482 BACKGROUND

• Roef G, Taes Y, Toye K, Goemaere S, Fiers T, Verstraete A, Kaufman JM. Heredity and lifestyle in the determination of between-subject variation in thyroid hormone levels in euthyroid men. Eur J Endocrinol. 2013 Oct 21;169(6):835-44. doi: 10.1530/EJE-13-0265. Print 2013 Dec.

  PMID: 24086088 BACKGROUND

• De Naeyer H, Bogaert V, De Spaey A, Roef G, Vandewalle S, Derave W, Taes Y, Kaufman JM. Genetic variations in the androgen receptor are associated with steroid concentrations and anthropometrics but not with muscle mass in healthy young men. PLoS One. 2014 Jan 23;9(1):e86235. doi: 10.1371/journal.pone.0086235. eCollection 2014.

  PMID: 24465978 BACKGROUND

• Gysel T, Calders P, Cambier D, Roman de Mettelinge T, Kaufman JM, Taes Y, Zmierczak HG, Goemaere S. Association between insulin resistance, lean mass and muscle torque/force in proximal versus distal body parts in healthy young men. J Musculoskelet Neuronal Interact. 2014 Mar;14(1):41-9.

  PMID: 24583539 BACKGROUND

• Verroken C, Zmierczak HG, Goemaere S, Kaufman JM, Lapauw B. Association of Jumping Mechanography-Derived Indices of Muscle Function with Tibial Cortical Bone Geometry. Calcif Tissue Int. 2016 May;98(5):446-55. doi: 10.1007/s00223-015-0094-2. Epub 2015 Dec 16.

  PMID: 26671019 BACKGROUND

• Verroken C, Zmierczak HG, Goemaere S, Kaufman JM, Lapauw B. Maternal age at childbirth is associated with offspring insulin sensitivity: a cross-sectional study in adult male siblings. Clin Endocrinol (Oxf). 2017 Jan;86(1):52-59. doi: 10.1111/cen.13253. Epub 2016 Nov 2.

  PMID: 27726168 BACKGROUND

• Verroken C, Zmierczak HG, Goemaere S, Kaufman JM, Lapauw B. Bone Turnover in Young Adult Men: Cross-Sectional Determinants and Associations With Prospectively Assessed Bone Loss. J Bone Miner Res. 2018 Feb;33(2):261-268. doi: 10.1002/jbmr.3303. Epub 2017 Nov 17.

  PMID: 28987002 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

* Venous blood sampling after overnight fast, with whole blood, serum and plasma samples to be retained * Second void urine samples to be retained

MeSH Terms

Conditions

Multiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Study Officials

• Bruno Lapauw, M.D., Ph.D.

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: December 19, 2016
• Study Start: May 1, 2014
• Primary Completion: December 12, 2019
• Study Completion: December 31, 2020
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

BE (1)