Bone Density Clinical Trial
Official title:
Longitudinal Extension Phase of Sibling Pair Linkage Analysis of Bone Mineral Density / Geometry and Sex Steroid and Thyroid Status in Healthy Young Men
NCT number | NCT02997033 |
Other study ID # | 2013/1090 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 2014 |
Est. completion date | December 31, 2020 |
Verified date | February 2023 |
Source | University Hospital, Ghent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 709 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 12, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 25 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Ghent University Hospital, Dept. of Endocrinology | Ghent |
Lead Sponsor | Collaborator |
---|---|
University Ghent |
Belgium,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in bone mineral density | Change in bone mineral density vs. baseline (= study visit in SIBLOS study) | ten years | |
Secondary | Change in sex steroid levels | Change in sex steroid levels vs. baseline (= study visit in SIBLOS study) | ten years | |
Secondary | Change in body composition | Change in body composition vs. baseline (= study visit in SIBLOS study) | ten years |
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