MedPath

Bone health in professional cycling

Conditions
Osteoporosis
Registration Number
NL-OMON27586
Lead Sponsor
HAN University of Applied Sciences
Brief Summary

ot applicable

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
75
Inclusion Criteria

Inclusion criteria

World tour level (highest level) professional male cyclists (aged 22 – 40):
•Male
•Professional cyclist competing in UCI’s WorldTour competition
•Willing to give written informed consent.
•Willing to comply with study procedures.
•Accept use of all encoded data, including publication, and the confidential use and storage of all data for 15 years.

World tour level professional female cyclists (aged 22 – 40):
•Female
•Professional cyclist competing in UCI’s Women’s WorldTour competition
•Willing to give written informed consent.
•Willing to comply with study procedures.
•Accept use of all encoded data, including publication, and the confidential use and storage of all data for 15 years.

Talented elite male cyclist (aged 18 – 22):
•Male
•Included in a talent program of professional cycling team
•Willing to give written informed consent.
•Willing to comply with study procedures.
•Accept use of all encoded data, including publication, and the confidential use and storage of all data for 15 years.

Retired world tour level professional cyclists (aged 35 – 60):
•Retired male of female professional cyclist.
•A minimum of 5 years of professional cycling at WorldTour level.
•Duration of retirement is minimal 1 year before Day 01 of this study.
•Willing to give written informed consent.
•Willing to comply with study procedures.
•Accept 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 events or medication use that may significantly affect bone metabolism, to be decided by the principal investigator.
•Medication use that may affect tests within this study must be minimal 3 months before Day 01 of this study.
•Participation in any clinical trial including blood sampling and/or administration of substances up to 30 days before Day 01 of this study
•A recent injury that may significantly affect BMD, to be decided by the principal investigator.

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Whole body and regional (lumbar spine and femoral hip) bone mineral density (t- and z-scores) and bone mineral content as determined by dual-energy X-ray absorptiometry (DXA).
Secondary Outcome Measures
NameTimeMethod
Whole body and regional (lumbar spine and femoral hip) bone mineral content as determined by dual-energy X-ray absorptiometry (DXA).<br>Cycling exercise volume during the preceding 12 months (for retired cyclists we obtain the average volume during a 5 year period in their career). <br>Dietary intake (energy, macronutrients, calcium, vitamin D).<br>Blood parameters of bone health: Procollagen type I N propeptide (P1NP), carboxy-terminal crosslinking telopeptide of type I collagen (CTX-I), calcitonine, parathyroid hormone (PTH), testosterone and oestrogen.<br>Current and life time sports participation.
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