An observational study in Osteoporosis, Sarcopenia and Obesity, sponsored by Holbaek Sygehus. Enrolling by invitation at 9 sites in Denmark. Open to participants aged 18 Years to 19 Years. Per ClinicalTrials.gov, last updated 2025-01-10.
Sponsored by Holbaek Sygehus · Observational
Diseases which can be the result of poor lifestyle choices in adult life, such as osteoporosis, obesity or poor muscle mass (sarcopenia) can also be driven by heritable genetic factors. More surprisingly, perhaps, the genes we inherit from our parents can be modified as a result of influences that affected the health and pregnancy of our mothers and hence the environment experienced in the womb and at birth. The purpose of this study is to investigate which factors are needed for good bone health and hormonal health in young adulthood as well as good muscle mass and normal fat mass, and how this is influenced by factors before birth and by childhood health. Specifically, we will measure bone mass and body composition in young adults (18 years of age) and measure hormones in blood and in hair samples. The clinical visits will be available nationwide at several centers to make participation swift and easy for participants. The changes (known as epigenetic modification) to genes at birth will be studied in dried blood spot samples stored from birth 18 years ago in the Danish Serum Institute and we will use national health registers to identify factors during pregnancy and in childhood that contribute to health effects at age 18.
Population-based, nationwide, cross-sectional, clinical study with already available early life exposure data including bio banked neonatal biological samples. An embedded design using the full 2006+2007 birth cohorts is used to demonstrate external validity of the clinically assessed cohort. We will obtain the necessary ethics and regulatory approval and individual consent from the participants who are all aged 18.
The overall aim of the project addresses whether the following sets of potential determinants are associated with young adult hormonal status, lipids, bone turnover markers, bone mineral density (BMD), fat mass and lean body mass at age 18 years: a) maternal risk factors during preconception and pregnancy; b) risk factors at birth; c) neonatal epigenetic signature; d) childhood risk factors.
Aim 1 - Epigenetics - Is peak bone mass and body size influenced by epigenetic profile for endocrine signals at birth? From the second trimester of pregnancy and until early adulthood, bone is gradually developed and shaped, with longitudinal growth dominating the later stages of fetal life, infancy, and childhood. This is followed by a period of rapid bone mineral accrual occurring up to and during puberty, with bone mass accretion ultimately reaching a plateau in young adult life. It is strongly suggested by prior research that epigenetic variation at birth can result from differences in maternal health, lifestyle, nutrition, smoking and medication usage and result in long-term changes in gene expression and metabolism.
As existing childhood cohorts either lack BMD information, suffer from significant cohort attrition, and low recruitment success, there is an opportunity to instead use national invitations to recruit directly into an efficient endocrine and bone outcomes study and use already archived biological material from early infancy and register data and obtain individual study subject consent.
Aim 2 - Endocrine status in young adulthood - Does maternal medication use and health issues prior to pregnancy or in pregnancy affect endocrine health in young adults? This question will be addressed using data from Danish national registers. While it is straightforward to link binary events data e.g., malformations or paediatric admissions (eg epilepsy, diabetes, failure to thrive) to registry capture of their maternal exposures, we will be obtaining detailed information about continuous outcomes including endocrine serum biochemistry (thyroid axis, GH axis, PTH-vitamin D-calcium axis, lipids, HbA1c), hair cortisol levels (a cumulative serum cortisol metric) as well as body composition and bone density metrics.
Aim 3 - DXA measured muscle, fat mass and lipid status in young adults - Do suboptimal conditions prior to pregnancy, during pregnancy, birth, and childhood, such as lifestyle, poor health and low socioeconomics adversely influence establishment of healthy body composition and lipid status in young adulthood? Detailed register-based information prior to pregnancy, about pregnancy, birth and childhood health will be used to identify areas open to prevention. Detailed information will be obtained via the Danish national health registers.
Statistical consideration - With a study population of 2,000, the power (given α=0.05) available to detect a 0.2 SD effect on a continuous outcome such as PBM for a risk factor with a population prevalence of 20% is 90%. With inclusion of 1,500 subjects, the corresponding study power is 90% for detection of an effect size of 0.24 SD or 80% for detection of an effect size of 0.2 SD. The study needs this resolving power to be able to address multiple contributing factors and for the inclusion of factors in the model that may have a population prevalence below 20%. Less common factors would, even if powerful drivers of skeletal health, be somewhat less useful in population impact even if successfully modified.
Biological material - All material for use in the current project will be stored in a research biobank during the current study during its term. Any remaining material is transferred to biobank for future research with the approval of the Danish Data Protection Agency. The purpose of the biobank is to ensure validation of the analysis methods used over time. The participants must give consent to the storage of their biological material in the biobank. It is completely optional if the participants want to donate their excess biological material to the biobank and if they do not want this, it does not affect their participation in the study. For new research, new consent must be obtained, but the Scientific Ethics Committee can grant exemption from the consent requirement.
All material will be stored in compliance with Danish legislation on data protection.
24 mL of blood will be drawn. All blood samples are encoded so that all samples are anonymized, and the key is under special protection and only with access for authorized personnel. All extra material will be kept in the biobank.
To ensure uniformity between neonatal and adolescent samples, DBS will be created from the freshly drawn whole blood. DBS are created by spotting 3x75µL onto a cotton filter paper of the same type used in 2006-2007. The cards are left overnight at ambient temperatures then transferred to -20C for long term storage. DNA is be extracted from two 3.2mm disks excised from the DBS card, then purified using magnetic silica beads. Finally, concentrations are measured using intercalating dyes.
All hair samples (minimum 20 mg per participant) will be encoded so that all samples are pseudonymised, and the key is under special protection and only with access for authorized personnel. All hair samples will be used in the analyses, and then discarded.
1,601 studies on the registry are indexed under Osteoporosis; 209 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 160 across 455 observational studies indexed under Osteoporosis.
Browse Osteoporosis studies →Holbaek Sygehus is the lead sponsor of 27 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The Danish Personal Civil Registration will be used to identify all alive individuals born in Denmark in 2006 and 2007 using civil registration numbers. Invitations will be sent through secure e-mail (E-boks) in blocks until 2,000 participants have been reached. The study population will be selected with representative geographical distribution in Denmark.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Random subsample of all 17-18-year-old individuals in Denmark, i.e. live births from year 2006 and 2007.
Bone Mineral Density of Spine, Hip and Whole-body
The Dual-energy X-ray Absorptiometry (DXA) measures the bone mineral density (BMD) of the spine, hip and whole-body.
Time frame: Baseline
Bone Mineral Density of Spine, Hip and Whole-body
The Dual-energy X-ray Absorptiometry (DXA) measures the bone mineral density (BMD) of the spine, hip and whole-body.
Time frame: 2 years
Bone Area of Spine, Hip and Whole-body
The Dual-energy X-ray Absorptiometry (DXA) measures the bone area (BA) of the spine, hip and whole-body.
Time frame: Baseline
Bone Area of Spine, Hip and Whole-body
The Dual-energy X-ray Absorptiometry (DXA) measures the bone area (BA) of the spine, hip and whole-body.
Time frame: 2 years
Bone Mineral Content of Spine, Hip and Whole-body
The Dual-energy X-ray Absorptiometry (DXA) measures the bone mineral content (BMC) in the spine, hip and whole-body.
Time frame: Baseline
Bone Mineral Content of Spine, Hip and Whole-body
The Dual-energy X-ray Absorptiometry (DXA) measures the bone mineral content (BMC) in the spine, hip and whole-body.
Time frame: 2 years
Total Body Lean Mass
The Dual-energy X-ray Absorptiometry (DXA) measures the whole-body densitometry, providing information on total body lean mass in kg.
Time frame: Baseline
Total Body Lean Mass
The Dual-energy X-ray Absorptiometry (DXA) measures the whole-body densitometry, providing information on total body lean mass in kg.
Time frame: 2 years
Total Body Fat Mass
The Dual-energy X-ray Absorptiometry (DXA) measures the whole-body densitometry, providing information on total body fat mass in kg.
Time frame: Baseline
Total Body Fat Mass
The Dual-energy X-ray Absorptiometry (DXA) measures the whole-body densitometry, providing information on total body fat mass in kg.
Time frame: 2 years
High-Resolution Peripheral Quantitative Computed Tomography of The Distal Radius and Tibia
High-resolution peripheral quantitative computed tomography (HRpQCT) of the distal radius and tibia will provide structural information including cortical thickness, trabecular number, trabecular thickness and volumetric bone mineral density (vBMD)
Time frame: Baseline
High-Resolution Peripheral Quantitative Computed Tomography of The Distal Radius and Tibia
High-resolution peripheral quantitative computed tomography (HRpQCT) of the distal radius and tibia will provide structural information including cortical thickness, trabecular number, trabecular thickness and volumetric bone mineral density (vBMD)
Time frame: 2 years
Body Weight
Weight will be measured to the nearest 0.1 kg on an electronic scale with participants wearing light clothing. Measurement will be carried out barefoot.
Time frame: Baseline
Body Weight
Weight will be measured to the nearest 0.1 kg on an electronic scale with participants wearing light clothing. Measurement will be carried out barefoot.
Time frame: 2 years
Height
Height will be measured to the nearest 0.5 cm using a portable stadiometer. Measurement will be carried out barefoot
Time frame: Baseline
Height
Height will be measured to the nearest 0.5 cm using a portable stadiometer. Measurement will be carried out barefoot
Time frame: 2 years
Body Mass Index
Body Mass Index (BMI) will be calculated based on the participant's weight and height
Time frame: Baseline
Body Mass Index
Body Mass Index (BMI) will be calculated based on the participant's weight and height
Time frame: 2 years
Waist Circumference
The waist circumference will be measured using a measuring tape to the nearest 0.5 cm. At least two measurements will be performed and a third will be made if the two differs by more than 1 cm
Time frame: Baseline
Waist Circumference
The waist circumference will be measured using a measuring tape to the nearest 0.5 cm. At least two measurements will be performed and a third will be made if the two differs by more than 1 cm
Time frame: 2 years
Hip Circumference
The hip circumference will be measured using a measuring tape to the nearest 0.5 cm. At least two measurements will be performed and a third will be made if the two differs by more than 1 cm
Time frame: Baseline
Hip Circumference
The hip circumference will be measured using a measuring tape to the nearest 0.5 cm. At least two measurements will be performed and a third will be made if the two differs by more than 1 cm
Time frame: 2 years
Waist-Hip Ratio
The waist-hip ratio is calculated using the waist and hip circumference
Time frame: Baseline
Waist-Hip Ratio
The waist-hip ratio is calculated using the waist and hip circumference
Time frame: 2 years
Endocrine Status
Blood will be drawn for plasma analyses for endocrine status
Time frame: Baseline
Endocrine Status and Bone Markers of Bone Metabolism
Blood will be drawn for plasma analyses for endocrine status and biomarkers of bone metabolism (PINP and CTX)
Time frame: Baseline
Hair Cortisol Concentrations
The hair samples will be cut from the posterior apex as close to the scalp as possible (minimum 20 mg per participant). Cortisol extracted from the hair will be analysed via the Elisa method
Time frame: Baseline
Blood Pressure
Resting blood pressure will be measured
Time frame: Baseline
Blood Pressure
Resting blood pressure will be measured
Time frame: 2 years
Self-reported Stress
Information about well-being will be collected by electronic questionnaire, using the World Health Organization Well-Being index (WHO-5): (1) 'I have felt cheerful and in good spirits', (2) 'I have felt calm and relaxed', (3) 'I have felt active and vigorous', (4) 'I woke up feeling fresh and rested' and (5) 'My daily life has been filled with things that interest me'. The respondent is asked to rate how well each of the 5 statements applies to him or her when considering the last 14 days. Each of the 5 items is scored from 5 (all of the time) to 0 (none of the time). Score ranges from 0 (absence of well-being) to 25 (maximal well-being).
Time frame: Baseline
Self-reported Sleep
Information about sleep will be collected by electronic questionnaire. The respondent is asked about what time he or she goes to sleep and wakes up on the weekdays and weekends/holidays, as well as five elaborating questions about their sleeping pattern: (1) 'How often do you have poor or restless sleep?', (2) 'How often do you have trouble falling asleep?', (3) 'How often do you wake up too early in the morning?', (4) 'How often do you wake up multiple times at night and have trouble falling asleep again?' and (5) 'Do you snore loudly when you sleep?'. Each of the 5 items is scored from 4 (every day or almost every day) to 1 (rarely or never).
Time frame: Baseline
Self-reported Hearing
Information about tinnitus will be collected by electronic questionnaire. The respondent is asked the following five questions: (1) 'After listening to loud music or other sounds/noise, have you then heard any form of sounds in your head or ears, even after turning off the loud music or noise?', (2) 'Do you ever experience sounds in your head or ears without listening to loud music or other sounds first?', (3) 'Are you experiencing it today?', (4) 'Does the sound bother you?' and (5) 'How worried are you that sound can harm your hearing?'. The questions 1 to 3 are answered as yes or no. Question 4 is answered as not bothered; a little bothered or very bothered. Question 5 is I am not concerned; I am a little concerned or I am seriously concerned.
Time frame: Baseline
Plan to share: Undecided
Started Nov 2024 (actual). Primary completion is estimated for Sep 2026, 22 months after the start.
Of 114 non-industry observational studies under Osteoporosis, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 113. This study's planned 22 months is below that.
Counting every sponsor, half of 125 studies reached it within 51 months; a quarter within 24 and three quarters within 97.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Holbaek Sygehus