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ID
Source
Brief title
Health condition
Osteoporosis
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
Whole body and regional (lumbar spine and femoral hip) bone mineral content as determined by dual-energy X-ray absorptiometry (DXA).
Cycling exercise volume during the preceding 12 months (for retired cyclists we obtain the average volume during a 5 year period in their career).
Dietary intake (energy, macronutrients, calcium, vitamin D).
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.
Current and life time sports participation.
Background summary
Bone is a highly dynamic tissue that undergoes constant remodeling, mainly influenced by physical activity. Non-weight-bearing activities, such as cycling do not contribute to bone health, with potentially severe consequences for individuals who engage in high volume non-weight-baring exercise training and competition such as professional cyclists. There is a lack of data on the time course and severity of low bone mineral density in professional and retired cyclists. We hypothesize that the greater part of professional cyclist will be diagnosed with osteopenia or osteoporosis. Furthermore, we expect that low bone mineral density will not be normalized after the active career.
Study objective
We hypothesize that the greater part of professional cyclist will be diagnosed with osteopenia or osteoporosis. Furthermore, we expect that low bone mineral density will not be normalized after the active career.
Study design
A subgroup of young talented cyclists will be followed over a 4 year period, including yearly measurements of bone mineral density during the off-season.
Intervention
None
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.
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL8691 |
| Other | METC Zuyderland : METCZ20200039 |