Bone Disease, MetabolicSportMarkersNCT03386981
Metabolic Profile of Bone in Professional Athletes
An observational study of Bone Disease, Metabolic and Physical Activity, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bone Disease, Metabolic, Physical Activity
- What is being tested?
- blood and saliva tests
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 4 Feb 2016to 4 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 200 subjects will be recruited. They will be recruited among professional athletes and technical staff of the cooperating teams
Who may be able to join
- >/= 18 yo
- healthy status
- caucasians
Who cannot join
- < 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Ortopedico Galeazzi
Milan, 20161
Giovanni Lombardi, PhD, 00390216621 ext. 4068, giovanni.lombardi@grupposandonato.it
Elena Cittera, MSc, 00390216621 ext. 4057, elena.cittera@grupposandonato.it
About this study
Official title: 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.
Read the 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.
- Conditions
- Bone Disease, Metabolic, Physical Activity
- Being tested
- blood and saliva tests
- Keywords
- Energy metabolism, Homeostasis, Bone turnover markers
- Medical subject headings
- Bone Diseases, Metabolic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood and saliva testsOther
Blood and saliva will be tested for: bone turnover markers, cytokines, chemokines, adipokines, myokines and hormones regulating bone and energy metabolism
| Study group | Role | What they receive |
|---|---|---|
| 1 | Professional athletes: Professional athletes belonging to different discipline Receives: Other: blood and saliva tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0-36 Months
Secondary outcomes (1)
myokines, adipokines, cytokines, chemokines, hormones regulating bone and energy metabolism
different markers will be assayed depending on the group of subjects
Measured: 0-36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start4 Feb 2016
- Primary completion4 Feb 2026 (estimated)
- Study completion4 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Bone Disease, MetabolicStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Cittera, I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03386981
- Sponsor's protocol ID
- SportMarkers
- Acronym
- SportMarkers
- Status last verified
- Aug 2025
- First submitted
- 5 Dec 2017
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Case Report Form (CRF) will be available
Publications
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.
PubMed 20632739Lombardi 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.
PubMed 22628324Chilibeck PD, Sale DG, Webber CE. Exercise and bone mineral density. Sports Med. 1995 Feb;19(2):103-22. doi: 10.2165/00007256-199519020-00003.
PubMed 7747001Murphy 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.
PubMed 15018482Snow 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.
PubMed 11685427Shackelford LC, LeBlanc AD, Driscoll TB, Evans HJ, Rianon NJ, Smith SM, Spector E, Feeback DL, Lai D; New Collective Author. 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.
PubMed 15220316Lombardi 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.
PubMed 22848709Seibel MJ. Biochemical markers of bone turnover: part I: biochemistry and variability. Clin Biochem Rev. 2005 Nov;26(4):97-122.
PubMed 16648882Corsetti 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.
PubMed 26306846Grasso 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.
PubMed 24433517Lombardi 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.
PubMed 23647316Lombardi 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.
PubMed 20878421Lombardi 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.
PubMed 22475109Lombardi 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.
PubMed 25158976Walsh 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.
PubMed 25368616
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Metabolic Profile of Bone in Professional Athletes as a Function of the Kind of Physical Activity Performed
- ClinicalTrials.gov ID
- NCT03386981
- Acronym / sponsor ID
- SportMarkers / SportMarkers
- Conditions
- Bone Disease, Metabolic, Physical Activity
- Keywords
- Energy metabolism, Homeostasis, Bone turnover markers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 4 Feb 2016 (actual)
- Primary completion
- 4 Feb 2026 (estimated)
- Study completion
- 4 Feb 2027 (estimated)
- First posted
- 29 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: blood and saliva testsProfessional athletes: Professional athletes belonging to different discipline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 200 subjects will be recruited. They will be recruited among professional athletes and technical staff of the cooperating teams
Key inclusion criteria (3 listed)
- >/= 18 yo
- healthy status
- caucasians
Key exclusion criteria (10 listed)
- < 18 yo
- pregnancy status
- ongoing or previous (<5 years) neoplasia
- acute or chronic inflammatory pathologies
- primary metabolic diseases of bone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood and saliva testsBlood and saliva will be tested for: bone turnover markers, cytokines, chemokines, adipokines, myokines and hormones regulating bone and energy metabolism | Other | 1 |
Primary outcome
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
1 secondary outcome
myokines, adipokines, cytokines, chemokines, hormones regulating bone and energy metabolism
Time frame: 0-36 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Results publication: PubMed 20632739Banfi 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.
- Results publication: PubMed 22628324Lombardi 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.
- Results publication: PubMed 7747001Chilibeck PD, Sale DG, Webber CE. Exercise and bone mineral density. Sports Med. 1995 Feb;19(2):103-22. doi: 10.2165/00007256-199519020-00003.
- Results publication: PubMed 15018482Murphy 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.
- Results publication: PubMed 11685427Snow 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.
- Results publication: PubMed 15220316Shackelford LC, LeBlanc AD, Driscoll TB, Evans HJ, Rianon NJ, Smith SM, Spector E, Feeback DL, Lai D; New Collective Author. 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.
- Results publication: PubMed 22848709Lombardi 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.
- Results publication: PubMed 16648882Seibel MJ. Biochemical markers of bone turnover: part I: biochemistry and variability. Clin Biochem Rev. 2005 Nov;26(4):97-122.
- Results publication: PubMed 26306846Corsetti 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.
- Results publication: PubMed 24433517Grasso 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.
- Results publication: PubMed 23647316Lombardi 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.
- Results publication: PubMed 20878421Lombardi 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.
- Individual participant dataSharing planned: No. Case Report Form (CRF) will be available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Disease, Metabolic and Physical Activity, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giovanni Lombardi, PhD (0039026621 ext. 4068, giovanni.lombardi@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone turnover markers (time frame: 0-36 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03386981, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.