Metabolic Profile of Bone in Professional Athletes (SportMarkers)

January 4, 2018 updated by: Elena Cittera, Istituto Ortopedico Galeazzi

Study of the Metabolic Profile of Bone in Professional Athletes as a Function of the Kind of Physical Activity Performed

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Genetics explain about 70% of the inter-individual variance of bone mineral density (BMD) but maintenance and acquisition of bone mass strikingly depend on environmental factors as diet, calcium intake (in both quantitative and qualitative terms), and physical activity (PA). Among these, the biomechanical load generated by different kinds of PA represents the most important physiological stimulus able to increase bone mass and density.

Bone is a metabolically active tissue that undergoes to continuous remodeling throughout the coupling of resorption (operated by osteoclasts) and formation (operated by osteoblasts). Osteocytes, the quiescent form of osteoblasts, regulate the activity of the other two cell types and directly respond to load. Under normal conditions, resorption and formation are strikingly coupled and this guarantees an equilibrium between old bone matrix removal and new matrix deposition. This equilibrium is dependent upon several hormones and local mediators (e.g., cytokines, myokines, adipokines). Physiological (e.g., growth, aging, PA) and pathological conditions (e.g., metabolic diseases, bed rest, drugs) inbalance this equilibrium towards one side and, hence, affect bone mass. Regarding PA, for example, it is known that weight-bearing aerobic activity has positive effects on BMD and, hence, it is considered a preventive strategy against post-menopausal bone loss.

Differently from radiological imaging, that gives information about established architectural changes happened at a specific site in bone, biochemical and molecular markers of bone turnover give an instantaneous picture of the metabolic status of bone cells and, possibly, their immediate response to a stimulus.

Other than the bony response, PA activates several endocrine responses and particularly, the whole set of responses needed for managing the energy stores and to save the most nobile functions (e.g., brain, hearth). Hence, bone is subjected to the endocrine regulation of energy usage but, as recently discovered, being it the primary mechanosensor of load, it acts itself as an endocrine organ able to signal to other tissues and organs the changing environmental conditions.

Although several molecular aspects about the effects of PA on bone metabolism and the bone-energy cross-talk, a number of unresolved questions still exists. The study of different physiological models (i.e., athletes belonging to different disciplines) might allow the identification of common mechanisms regulating the response to PA and, from another side, to understand the physiological response to different stresses applied onto the muscle-skeletal apparatus.

The general aim of this study is to investigate the effects of different kinds of professional physical activity on bone metabolism and the relationship between bone metabolism, energy metabolism, hormone profile, and organ functionality.

The primary aim is to deepen the knowledge of the molecular mechanisms by which PA modulates bone metabolism. Specifically, this study will evaluate the bony effects of specific kinds of PA, over the time (over an entire season, over consecutive seasons, during different phases of a season), as well as the direct comparison of the bony effects of different kinds of PA and training.

Secondary aims are:

  • to contextualize the modification of bone cell metabolism within the whole-body homeostatic profile. Particularly, markers of the energy metabolism and the inflammatory status (hormone, myokines, adipokines, cytokines, chemokines) will be evaluated.
  • focused case-control studies will be conducted by including as little-active control the people belonging to the technical staff of the cooperating teams.

This is a perspective monocentric pilot study with different components:

  • longitudinal perspective: repeated evaluations over the time
  • case-control: comparison among different populations of athletes and technical staff Being based on already planned blood drawings (as independently decided by the team physicians), and since the researchers will use only waste material derived from these sample, the overall implant of the study is observational.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

  • >/= 18 yo
  • healthy status
  • caucasians

Exclusion Criteria:

  • < 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Professional athletes: Professional athletes belonging to different discipline
Other: blood and saliva tests
Blood and saliva will be tested for: bone turnover markers, cytokines, chemokines, adipokines, myokines and hormones regulating bone and energy metabolism

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone turnover markers
Time Frame: 0-36 Months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
myokines, adipokines, cytokines, chemokines, hormones regulating bone and energy metabolism
Time Frame: 0-36 Months
different markers will be assayed depending on the group of subjects
0-36 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Galeazzi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 4, 2016

Primary Completion (ANTICIPATED)

February 4, 2019

Study Completion (ANTICIPATED)

February 4, 2019

Study Registration Dates

First Submitted

December 5, 2017

First Submitted That Met QC Criteria

December 21, 2017

First Posted (ACTUAL)

December 29, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 5, 2018

Last Update Submitted That Met QC Criteria

January 4, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SportMarkers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Case Report Form (CRF) will be available

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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