We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Metabolic Profile of Bone in Professional Athletes (SportMarkers)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03386981
Recruitment Status : Recruiting
First Posted : December 29, 2017
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Bone Disease, Metabolic Physical Activity Other: blood and saliva tests

  Show Detailed Description

Study Design

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Study of the Metabolic Profile of Bone in Professional Athletes as a Function of the Kind of Physical Activity Performed
Actual Study Start Date : February 4, 2016
Estimated Primary Completion Date : February 4, 2019
Estimated Study Completion Date : February 4, 2019
Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


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

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03386981


Contacts
Contact: Giovanni Lombardi, PhD 0039026621 ext 4068 giovanni.lombardi@grupposandonato.it
Contact: Elena Cittera, MSc 0039026621 ext 4057 elena.cittera@grupposandonato.it

Locations
Italy
Istituto Ortopedico Galeazzi Recruiting
Milano, Italy, 20161
Contact: Giovanni Lombardi, PhD    00390216621 ext 4068    giovanni.lombardi@grupposandonato.it   
Contact: Elena Cittera, MSc    00390216621 ext 4057    elena.cittera@grupposandonato.it   
Sponsors and Collaborators
Istituto Ortopedico Galeazzi
More Information

Publications:

Responsible Party: Elena Cittera, Scientific Direction, Istituto Ortopedico Galeazzi
ClinicalTrials.gov Identifier: NCT03386981     History of Changes
Other Study ID Numbers: SportMarkers
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Case Report Form (CRF) will be available

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Elena Cittera, Istituto Ortopedico Galeazzi:
Energy metabolism
Homeostasis
Bone turnover markers

Additional relevant MeSH terms:
Bone Diseases
Metabolic Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases