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ELEMENTAL

Bone Quality Assessment in Athletes - Bone Quality Assessment in Athletes

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57967
Enrollment
240
Registered
2025-06-04
Start date
2026-02-06
Completion date
Unknown
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone health, osteoporosis, energy availability Bone strength, nutrional status

Interventions

None

Sponsors

HAN University of Applied Sciences
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Elite runners:Age 18 to 45 yearsNational or international level competitive athleteAverage weekly training volume =100 km per weekWilling to give informed consentWilling to comply to study proceduresAccept use of all encoded data, including publication, and the confidential use and storage of all data for 15 yearsAmateur runners:Age 18 to 45 years=3 years competitive athlete at the regional levelAverage weekly training volume =60 km per weekWilling to give informed consentWilling to comply to study proceduresAccept use of all encoded data, including publication, and the confidential use and storage of all data for 15 yearsElite cyclists:Age 18 to 45 yearsAffiliation with a Continental team, ProTeam or WorldTour teamWilling to give informed consentWilling to comply to study proceduresAccept use of all encoded data, including publication, and the confidential use and storage of all data for 15 yearsAmateur cyclists:Age 18 to 45 years=3 years average weekly training volume =12 hours per weekWilling to give informed consentWilling to comply to study proceduresAccept use of all encoded data, including publication, and the confidential use and storage of all data for 15 yearsElite swimmers:Age 18 to 45 yearsNational or international level competitive athleteWilling to give informed consentWilling to comply to study proceduresAccept use of all encoded data, including publication, and the confidential use and storage of all data for 15 yearsAmateur swimmers:Age 18 to 45 years=3 years active as a competitive swimmer at the regional levelWilling to give informed consentWilling to comply to study proceduresAccept use of all encoded data, including publication, and the confidential use and storage of all data for 15 years

Exclusion criteria

Exclusion criteria: Having a history of medical conditions (e.g. hyper- or hypoparathyroidism, hyper- or hypothyroidism, diabetes mellitus, chronic kidney disease, rheumatoid arthritis) that may significantly affect bone metabolism.Use of medications known to interfere with bone metabolism (e.g., glucocorticoids, thyroid hormones in supraphysiological doses, aromatase inhibitors, anti-seizure medication) within three months prior to Day 01 of the study (use of hormonal contraception (e.g., oral contraceptives, hormonal intrauterine devices, implants) is not an exclusion criterion).Use of antiresorptive or anabolic bone agents within one year prior to Day 01 of the study.Participation in any clinical trial including blood sampling and/or administration of substances up to 30 days before Day 01 of this study.Participants who have had a traumatic fracture recently (<2 years) at both distal radii and distal tibiae will be excluded from the HR-pQCT measurement. Female participants who are pregnant or lactating.Smoking (current heavy smoking, >10 cigarettes/day).Excessive alcohol consumption (>3 drinks/day).

Design outcomes

Primary

MeasureTime frame
Lumbar spine, total hip and femoral neck bone mineral density.Volumetric BMD and cortical and trabecular microarchitecture of the distal radius and tibia.Bone strength (failure load) of the distal radius and tibia.

Secondary

MeasureTime frame
Whole body BMD, as assessed by DXA.Non-dominant forearm BMD, as assessed by DXA.Presence of a vertebral fracture as assessed by Vertebral Fracture Assessment (VFA) with DXA.Anthropometrics (height, weight, lean mass, fat mass)Average weekly exercise training volume during the preceding 12 months. Blood parameters of bone health and energy availability: Procollagen type I N propeptide (P1NP), carboxy-terminal crosslinking telopeptide of type I collagen (CTX-I), parathyroid hormone (PTH), Insulin-like growth factor (IGF-1), serum total and free triiodothyronine (T3), serum total and free testosterone.Current and life time sports participation.Low energy availability questionnaireEating Disorder Examination Questionnaire (EDE-Q)Tibial bone loading during a typical training speed as determined with markerless motion capture (OpenCap)

Countries

Netherlands

Contacts

Public ContactLPM Hilkens

HAN University of Applied Sciences

luuk.hilkens@han.nl024 353 0500

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Mar 20, 2026