Metabolic Profile of Bone in Professional Athletes

NCT03386981 | Recruiting

• 1 other identifier: SportMarkers
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Physical activity is a key stimulus for bone metabolism through both direct mechanisms (e.g., as a result of the applied load and/or impact) and indirect mechanisms (e.g., the activation of several metabolic pathways and the production of several mediators and effectors that have systemic effects). However, different kinds of physical activity exert different effects on bone and endocrine system. Aim of the study is to investigate the effects of different kinds of physical activity on bone metabolism and on the relationships existing between bone metabolism, energy metabolism, hormone profile, and organ functionality.

Conditions

Bone Disease, Metabolic; Physical Activity

Keywords

Energy metabolism; Homeostasis; Bone turnover markers

Outcome Measures

Primary Outcomes (1)

• Bone turnover markers

  different markers of bone turnover (osteocalcin, N-terminal type I pro-collagen, beta-crosslaps, osteopontin, bone-alkaline phosphatase, tartrate-resistant acid phosphatase 5b) will be tested depending on the group of subjects considered time-by-time

  0-36 Months

Secondary Outcomes (1)

• myokines, adipokines, cytokines, chemokines, hormones regulating bone and energy metabolism

  0-36 Months

Study Arms (1)

1

Professional athletes: Professional athletes belonging to different discipline

Other: blood and saliva tests

Interventions

blood and saliva tests OTHER

Blood and saliva will be tested for: bone turnover markers, cytokines, chemokines, adipokines, myokines and hormones regulating bone and energy metabolism

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 200 subjects will be recruited. They will be recruited among professional athletes and technical staff of the cooperating teams

You may qualify if:

• \>/= 18 yo
• healthy status
• caucasians

You may not qualify if:

• \< 18 yo
• pregnancy status
• ongoing or previous (\<5 years) neoplasia
• acute or chronic inflammatory pathologies
• primary metabolic diseases of bone
• recent bone fractures (\< 6 months)
• chronic drugs
• recent drugs administration (\< 2 months) for non steroidal anti-inflammatory drugs (NSAIDs) and steroids
• anxious-depressive conditions
• inability to understand the information given by the recruiting physician

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

Istituto Ortopedico Galeazzi

Milan, 20161, Italy

RECRUITING

Related Publications (18)

• Banfi G, Lombardi G, Colombini A, Lippi G. Bone metabolism markers in sports medicine. Sports Med. 2010 Aug 1;40(8):697-714. doi: 10.2165/11533090-000000000-00000.

  PMID: 20632739 BACKGROUND

• Lombardi G, Lanteri P, Colombini A, Banfi G. Blood biochemical markers of bone turnover: pre-analytical and technical aspects of sample collection and handling. Clin Chem Lab Med. 2012 Feb 3;50(5):771-89. doi: 10.1515/cclm-2011-0614.

  PMID: 22628324 BACKGROUND

• Chilibeck PD, Sale DG, Webber CE. Exercise and bone mineral density. Sports Med. 1995 Feb;19(2):103-22. doi: 10.2165/00007256-199519020-00003.

  PMID: 7747001 BACKGROUND

• Murphy NM, Carroll P. The effect of physical activity and its interaction with nutrition on bone health. Proc Nutr Soc. 2003 Nov;62(4):829-38. doi: 10.1079/PNS2003304.

  PMID: 15018482 BACKGROUND

• Snow CM, Williams DP, LaRiviere J, Fuchs RK, Robinson TL. Bone gains and losses follow seasonal training and detraining in gymnasts. Calcif Tissue Int. 2001 Jul;69(1):7-12. doi: 10.1007/s00223-001-0014-5. Epub 2001 Jun 5.

  PMID: 11685427 BACKGROUND

• Shackelford LC, LeBlanc AD, Driscoll TB, Evans HJ, Rianon NJ, Smith SM, Spector E, Feeback DL, Lai D. Resistance exercise as a countermeasure to disuse-induced bone loss. J Appl Physiol (1985). 2004 Jul;97(1):119-29. doi: 10.1152/japplphysiol.00741.2003.

  PMID: 15220316 BACKGROUND

• Lombardi G, Lanteri P, Graziani R, Colombini A, Banfi G, Corsetti R. Bone and energy metabolism parameters in professional cyclists during the Giro d'Italia 3-weeks stage race. PLoS One. 2012;7(7):e42077. doi: 10.1371/journal.pone.0042077. Epub 2012 Jul 27.

  PMID: 22848709 BACKGROUND

• Seibel MJ. Biochemical markers of bone turnover: part I: biochemistry and variability. Clin Biochem Rev. 2005 Nov;26(4):97-122.

  PMID: 16648882 BACKGROUND

• Corsetti R, Barassi A, Perego S, Sansoni V, Rossi A, Damele CA, Melzi D'Eril G, Banfi G, Lombardi G. Changes in urinary amino acids excretion in relationship with muscle activity markers over a professional cycling stage race: in search of fatigue markers. Amino Acids. 2016 Jan;48(1):183-92. doi: 10.1007/s00726-015-2077-z. Epub 2015 Aug 26.

  PMID: 26306846 BACKGROUND

• Grasso D, Corsetti R, Lanteri P, Di Bernardo C, Colombini A, Graziani R, Banfi G, Lombardi G. Bone-muscle unit activity, salivary steroid hormones profile, and physical effort over a 3-week stage race. Scand J Med Sci Sports. 2015 Feb;25(1):70-80. doi: 10.1111/sms.12147. Epub 2013 Oct 31.

  PMID: 24433517 BACKGROUND

• Lombardi G, Corsetti R, Lanteri P, Grasso D, Vianello E, Marazzi MG, Graziani R, Colombini A, Galliera E, Corsi Romanelli MM, Banfi G. Reciprocal regulation of calcium-/phosphate-regulating hormones in cyclists during the Giro d'Italia 3-week stage race. Scand J Med Sci Sports. 2014 Oct;24(5):779-87. doi: 10.1111/sms.12080. Epub 2013 May 7.

  PMID: 23647316 BACKGROUND

• Lombardi G, Colombini A, Freschi M, Tavana R, Banfi G. Seasonal variation of bone turnover markers in top-level female skiers. Eur J Appl Physiol. 2011 Mar;111(3):433-40. doi: 10.1007/s00421-010-1664-7. Epub 2010 Sep 29.

  PMID: 20878421 BACKGROUND

• Lombardi G, Lanteri P, Colombini A, Mariotti M, Banfi G. Sclerostin concentrations in athletes: role of load and gender. J Biol Regul Homeost Agents. 2012 Jan-Mar;26(1):157-63.

  PMID: 22475109 BACKGROUND

• Lombardi G, Perego S, Luzi L, Banfi G. A four-season molecule: osteocalcin. Updates in its physiological roles. Endocrine. 2015 Mar;48(2):394-404. doi: 10.1007/s12020-014-0401-0. Epub 2014 Aug 27.

  PMID: 25158976 BACKGROUND

• Walsh MC, Choi Y. Biology of the RANKL-RANK-OPG System in Immunity, Bone, and Beyond. Front Immunol. 2014 Oct 20;5:511. doi: 10.3389/fimmu.2014.00511. eCollection 2014.

  PMID: 25368616 BACKGROUND

• Lombardi G, Sanchis-Gomar F, Perego S, Sansoni V, Banfi G. Implications of exercise-induced adipo-myokines in bone metabolism. Endocrine. 2016 Nov;54(2):284-305. doi: 10.1007/s12020-015-0834-0. Epub 2015 Dec 30.

  PMID: 26718191 BACKGROUND

• Fang S, Deng Y, Gu P, Fan X. MicroRNAs regulate bone development and regeneration. Int J Mol Sci. 2015 Apr 13;16(4):8227-53. doi: 10.3390/ijms16048227.

  PMID: 25872144 BACKGROUND

• Allison RJ, Farooq A, Hamilton B, Close GL, Wilson MG. No association between vitamin D deficiency and markers of bone health in athletes. Med Sci Sports Exerc. 2015 Apr;47(4):782-8. doi: 10.1249/MSS.0000000000000457.

  PMID: 25058327 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and saliva will be collected under standard procedures as routine procedure independently decided by the team physicians. Waste material will be collected and analyzed for the aims of the study

MeSH Terms

Conditions

Bone Diseases, Metabolic; Motor Activity

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Giovanni Lombardi, PhD

CONTACT

0039026621; giovanni.lombardi@grupposandonato.it

Elena Cittera, MSc

CONTACT

0039026621; elena.cittera@grupposandonato.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Direction

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: December 29, 2017
• Study Start: February 4, 2016
• Primary Completion: February 4, 2026
• Study Completion (Estimated): February 4, 2027
• Last Updated: September 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)