Bone DensityNCT02997033
SIBlos EXtension Study (SIBEX)
An observational study of Bone Density and Gonadal Steroid Hormones, run by University Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bone Density, Gonadal Steroid Hormones, Thyroid Hormones
- How many people
- 709 participants
- Where
- 1 siteBelgium
- Study dates
- May 2014to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants of the first SIBLOS study (recruited between 2002 and 2009)
Who may be able to join
- Full participation in the first SIBLOS study
- Informed consent
Who cannot join
- 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
Show all 27Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
Osteoporosis is a common disorder affecting both sexes, with a lifetime risk of sustaining a fragility fracture at age 50 y estimated at 40-50% in women and 13-22% in men. The age-specific fracture risk in men is about half that in women, which results in part from the achievement of a higher bone mass in men, in particular of larger bone size during growth. Bone size, mass and strength in the elderly depend on the accrual and loss of bone through time. Not only from an epidemiological but also from a potentially preventive viewpoint, it is important to understand the determinants of the components and to identify risk and protective factors for bone accrual or loss through life.
Hormonal status in men, e.g. gonadal and thyroid hormone levels, has a wide range of effects on different body compartments. For both thyroid and gonadal steroid levels, there exists a wide inter-individual variation, even among healthy young men. Up till now, it is not clear whether this variation represents true differences in hormonal exposure or whether it represents an inter-individual variation in hormonal responsiveness. Since prevalence of both thyroid disorders and age- and obesity-associated hypogonadism is rather high, it is relevant to assess determinant and clinical correlates of the between-subject variation in sex steroid and thyroid hormone status.
Our research department therefore undertook a cross-sectional, population-based study in healthy men aged 25-45 years with the aim to investigate determinants of peak bone mass and between-subject variation in gonadal and thyroid hormone status (SIBLOS study). In total, 1114 men were recruited from 2002 till 2009. Herein, we focused on genetic determinants (SNPs, single nucleotide polymorphisms) contributing to between-subject differences in bone mass, as well as on the interrelationship between body composition, bone mass, density and size, lifestyle and hormonal status (sex steroids, thyroid hormones). In addition, we assessed determinants of sex steroid and thyroid hormone status, again focusing on genetic polymorphisms, body composition and lifestyle factors. The investigations in the SIBLOS study have been performed using state-of-the-art technology such as dual-energy X-ray absorptiometry and peripheral quantitative computed tomography for evaluating bone, muscle and body composition parameters; assessment of anthropometric parameters by well-trained personnel; validated questionnaires regarding lifestyle, physical activity and calcium intake; the use of liquid gas chromatography / mass spectrometry for assessing serum hormonal levels; using KASPar technology for genotyping after a high-yield DNA extraction procedure.
From this cross-sectional study, for example, following results have emerged:
- Estradiol seems to be the main sex steroid associated with bone mineral density and bone geometry, whereas testosterone was weakly associated with parameters reflecting muscle strength. In addition, serum estradiol levels might modulate the impact of physical activity on bone size at the tibia.
- Smokers presented with a higher prevalence of previous fractures, especially if they started smoking at younger age. This could be partly explained by the observation of lower bone mineral density and a thinner cortex in smokers.
- Physical activity, muscle mass and parameters reflecting muscle force are strongly associated with bone size; whereas fat mass displayed an inverse association with bone mass and size.
- Birth weight is associated with higher testosterone levels at adult age; in addition weight gain higher/lower than expected during life associated with lower/higher testosterone levels at adult age.
- Serum levels of sex-hormone binding globulin are positively associated with bone size in adult men.
- Higher serum thyroid hormone levels are associated with lower bone mineral density and cortical bone area.
- A less favorable body composition (higher fat and lower muscle mass) and insulin resistance are associated with higher serum thyroid hormone concentrations.
- Serum thyroid hormone levels are influenced by SNPs in the monocarboxylate transporter (MCT)-8 gene.
- Testosterone serum levels are associated with genetic polymorphisms in the genes encoding for the androgen receptor and sex-hormone binding globulin.
Our initial analyses in this SIBLOS population are cross-sectional. Although revealing, this, as any, cross-sectional study has limitations, mainly because the associations do not allow conclusions about direction nor causality. To add prospective elements to the acquired data and to investigate changes over time, we plan to perform a longitudinal follow-up in this study population (SIBEX - SIBlos EXtension study), and as in the mean time knowledge has increased and new questions have emerged, additional investigations are intended. The general aims of this follow-up study include the evaluation of changes in bone mineral density, bone geometry, body composition, parameters reflecting muscle force and sex steroid status in healthy young men, +-10 years after their initial evaluation in the SIBLOS cohort.
- Conditions
- Bone Density, Gonadal Steroid Hormones, Thyroid Hormones
- Being tested
- No intervention
- Keywords
- Bone, Sex steroids, Body composition, Men
- Medical subject headings
- Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Total study cohort | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bone mineral density
Change in bone mineral density vs. baseline (= study visit in SIBLOS study)
Measured: ten years
Secondary outcomes (2)
Change in sex steroid levels
Change in sex steroid levels vs. baseline (= study visit in SIBLOS study)
Measured: ten years
Change in body composition
Change in body composition vs. baseline (= study visit in SIBLOS study)
Measured: ten years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study startMay 2014
- Primary completion12 Dec 2019
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Bone DensityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 709 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno Lapauw, M.D., Ph.D., Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02997033
- Sponsor's protocol ID
- 2013/1090
- Status last verified
- Feb 2023
- First submitted
- 14 Dec 2016
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18519175Bogaert 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.
PubMed 18598274Lapauw 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.
PubMed 19113912Vanbillemont 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.
PubMed 18681858Bogaert 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.
PubMed 19383805Taes 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.
PubMed 19401374Taes 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.
PubMed 19653814Vanbillemont 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.
PubMed 20130068Taes 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.
PubMed 20200932Vanbillemont 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.
PubMed 20133463Roef 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.
PubMed 21393448Vanbillemont 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.
PubMed 21711374Boudin 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.
PubMed 22178351Boudin 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.
PubMed 22608881Roef 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.
PubMed 22956557
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02997033
- Acronym / sponsor ID
- 2013/1090
- Conditions
- Bone Density, Gonadal Steroid Hormones, Thyroid Hormones
- Keywords
- Bone, Sex steroids, Body composition, Men
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 709 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- 12 Dec 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 19 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Osteoporosis is a common disorder affecting both sexes, with a lifetime risk of sustaining a fragility fracture at age 50 y estimated at 40-50% in women and 13-22% in men. The age-specific fracture risk in men is about half that in women, which results in part from the achievement of a higher bone mass in men, in particular of larger bone size during growth. Bone size, mass and strength in the elderly depend on the accrual and loss of bone through time. Not only from an epidemiological but also from a potentially preventive viewpoint, it is important to understand the determinants of the components and to identify risk and protective factors for bone accrual or loss through life.
Hormonal status in men, e.g. gonadal and thyroid hormone levels, has a wide range of effects on different body compartments. For both thyroid and gonadal steroid levels, there exists a wide inter-individual variation, even among healthy young men. Up till now, it is not clear whether this variation represents true differences in hormonal exposure or whether it represents an inter-individual variation in hormonal responsiveness. Since prevalence of both thyroid disorders and age- and obesity-associated hypogonadism is rather high, it is relevant to assess determinant and clinical correlates of the between-subject variation in sex steroid and thyroid hormone status.
Our research department therefore undertook a cross-sectional, population-based study in healthy men aged 25-45 years with the aim to investigate determinants of peak bone mass and between-subject variation in gonadal and thyroid hormone status (SIBLOS study). In total, 1114 men were recruited from 2002 till 2009. Herein, we focused on genetic determinants (SNPs, single nucleotide polymorphisms) contributing to between-subject differences in bone mass, as well as on the interrelationship between body composition, bone mass, density and size, lifestyle and hormonal status (sex steroids, thyroid hormones). In addition, we assessed determinants of sex steroid and thyroid hormone status, again focusing on genetic polymorphisms, body composition and lifestyle factors. The investigations in the SIBLOS study have been performed using state-of-the-art technology such as dual-energy X-ray absorptiometry and peripheral quantitative computed tomography for evaluating bone, muscle and body composition parameters; assessment of anthropometric parameters by well-trained personnel; validated questionnaires regarding lifestyle, physical activity and calcium intake; the use of liquid gas chromatography / mass spectrometry for assessing serum hormonal levels; using KASPar technology for genotyping after a high-yield DNA extraction procedure.
From this cross-sectional study, for example, following results have emerged:
- Estradiol seems to be the main sex steroid associated with bone mineral density and bone geometry, whereas testosterone was weakly associated with parameters reflecting muscle strength. In addition, serum estradiol levels might modulate the impact of physical activity on bone size at the tibia.
- Smokers presented with a higher prevalence of previous fractures, especially if they started smoking at younger age. This could be partly explained by the observation of lower bone mineral density and a thinner cortex in smokers.
- Physical activity, muscle mass and parameters reflecting muscle force are strongly associated with bone size; whereas fat mass displayed an inverse association with bone mass and size.
- Birth weight is associated with higher testosterone levels at adult age; in addition weight gain higher/lower than expected during life associated with lower/higher testosterone levels at adult age.
- Serum levels of sex-hormone binding globulin are positively associated with bone size in adult men.
- Higher serum thyroid hormone levels are associated with lower bone mineral density and cortical bone area.
- A less favorable body composition (higher fat and lower muscle mass) and insulin resistance are associated with higher serum thyroid hormone concentrations.
- Serum thyroid hormone levels are influenced by SNPs in the monocarboxylate transporter (MCT)-8 gene.
- Testosterone serum levels are associated with genetic polymorphisms in the genes encoding for the androgen receptor and sex-hormone binding globulin.
Our initial analyses in this SIBLOS population are cross-sectional. Although revealing, this, as any, cross-sectional study has limitations, mainly because the associations do not allow conclusions about direction nor causality. To add prospective elements to the acquired data and to investigate changes over time, we plan to perform a longitudinal follow-up in this study population (SIBEX - SIBlos EXtension study), and as in the mean time knowledge has increased and new questions have emerged, additional investigations are intended. The general aims of this follow-up study include the evaluation of changes in bone mineral density, bone geometry, body composition, parameters reflecting muscle force and sex steroid status in healthy young men, +-10 years after their initial evaluation in the SIBLOS cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total study cohort | – | Other: No intervention |
Who may qualify
- Ages
- 25 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants of the first SIBLOS study (recruited between 2002 and 2009)
Key inclusion criteria (2 listed)
- Full participation in the first SIBLOS study
- Informed consent
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Total study cohort |
Primary outcome
Change in bone mineral density
Time frame: ten years
Change in bone mineral density vs. baseline (= study visit in SIBLOS study)
2 secondary outcomes
Change in sex steroid levels
Time frame: ten years
Change in body composition
Time frame: ten years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Background: PubMed 18519175Kaptoge 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.
- Background: PubMed 18598274Bogaert 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.
- Background: PubMed 19113912Lapauw 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.
- Background: PubMed 18681858Vanbillemont 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.
- Background: PubMed 19383805Bogaert 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.
- Background: PubMed 19401374Taes 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.
- Background: PubMed 19653814Taes 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.
- Background: PubMed 20130068Vanbillemont 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.
- Background: PubMed 20200932Taes 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.
- Background: PubMed 20133463Vanbillemont 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.
- Background: PubMed 21393448Roef 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.
- Background: PubMed 21711374Vanbillemont 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno Lapauw, M.D., Ph.D. principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Density and Gonadal Steroid Hormones, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bone mineral density (time frame: ten years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02997033, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.