Bone RemodelingOVADNCT07454252
Retrospective Monocentric Evaluation of Biomarkers Associated With Bone, Muscle and Energy Metabolism
An observational study of Bone Remodeling and Energy Metabolism, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Bone is a metabolically active tissue undergoing continuous remodeling through the coordinated actions of osteoclasts (resorption), osteoblasts (formation), and osteocytes (regulation). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bone Remodeling, Energy Metabolism
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- 10 Oct 2025to 30 Sep 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: Adults (age > 18 years), both male and female (n = 1000), undergoing routine blood sampling, whose biological specimens (blood and/or urine) were analyzed at the Laboratory Medicine Service of IRCCS San Raffaele Hospital, Milan, between January 1, 2006 and March 31, 2025.
Who may be able to join
- Age > 18 years.
- Blood sampling performed at the Laboratory Medicine Service of IRCCS San Raffaele Hospital, Milan, between January 1, 2006 and March 31, 2025.
Who cannot join
- -Age < 18 years
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
IRCCS San Raffaele Hospital
Milan, Italy, 20132
Eleonora Sabetta, MD, +390226435288, sabetta.eleonora@hsr.it
About this study
Bone is a metabolically active tissue undergoing continuous remodeling through the coordinated actions of osteoclasts (resorption), osteoblasts (formation), and osteocytes (regulation). Under physiological conditions, bone formation and resorption are balanced and regulated by systemic hormones (PTH, vitamin D, estrogens) and local mediators. However, aging, metabolic disorders, physical inactivity, or pharmacological treatments may disrupt this equilibrium, leading to the predominance of one process over the other. Circulating biochemical markers of bone turnover-classified into formation markers (P1NP, osteocalcin, bone alkaline phosphatase) and resorption markers (CTx-I, NTx-I, DPD)-provide a means to monitor these dynamics.
Beyond its mechanical role, bone also functions as an endocrine organ: osteocalcin, secreted by osteoblasts, modulates insulin secretion and sensitivity, linking bone to muscle and adipose tissue in the regulation of energy metabolism. Adipokines such as leptin and adiponectin further contribute to this complex crosstalk. Bone biomarkers are therefore essential for evaluating skeletal metabolism and identifying conditions such as osteoporosis, though the strict classification into formation versus resorption markers is limited, as some (e.g., osteocalcin) reflect both processes.
This study aims to analyze IRCCS San Raffaele database records of urinary and serum biomarkers related to bone, muscle, and energy metabolism, to assess their trends and associations according to age and sex, and to develop statistical models capable of explaining their interrelationships.
- Conditions
- Bone Remodeling, Energy Metabolism
- Keywords
- Energy metabolism, Bone resorption markers (CTx-I, NTx-I, deoxypyridinoline/DPD), Bone turnover markers (BTMs), Statistical modeling of metabolic interactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| OVAD cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate circulating levels of osteocalcin, the main non-collagenous protein bound to hydroxyapatite (HAP) and synthesized by osteoblasts-thus considered a biomarker of bone formation-in relation to circulating vitamin D, an endocrine factor involved
Osteocalcin data will be acquired, retrospectively, through the San Raffaele Hospital database from January 1st, 2016 to November 30th, 2023
Measured: As a retrospective study, data were obtained from the San Raffaele Hospital database for the period January 1, 2016, to November 30, 2023, regardless of patients' therapeutic paths.
Secondary outcomes (1)
As a secondary outcomes biomarkers of bone formation and reabsorption as well as biomarkers of skeletal muscle and energy metabolism will be evaluated in order to gain insights on how different tissues can influence each other.
The circulating levels of the following analytes will be analyzed to identify statistically significant associations between different biomarkers. Such associations may provide insights into how various tissues influence each other in relation to bone metabolism.
Due to character limits in this form, a more detailed description cannot be provided.
- Cross Linked C-telopeptide of Type I Collagen (CTx-I)
- Alkaline phosphatase protein (ALP)
- Urinary and serum creatinine
- Urinary Pyridinoline
- Calcium
- Ionized calcium
- Estrogen
- Creatin kinase (CK)
- Lactate dehydrogenase (LDH)
- Potassium
- Glucose
- Glucagon
- Insulin
- Triglycerides
- Total cholesterol
- Parathormone
- Thyrotropin
- Thyroglobulin
- Cortisol
The International Standard Unit of measurment (SI units) will be adopted fot the above analytes.
Data will be acquired, retrospectively, through the San Raffaele Hospital database from January 1st, 2016 to November 30th, 2023
Measured: As a retrospective study, data were obtained from the San Raffaele Hospital database for the period January 1, 2016, to November 30, 2023, regardless of patients' therapeutic paths.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start10 Oct 2025
- Primary completion1 Nov 2025
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone RemodelingStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo Locatelli, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07454252
- Sponsor's protocol ID
- OVAD
- Acronym
- OVAD
- Status last verified
- Mar 2026
- First submitted
- 5 Sep 2025
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Monocentric Evaluation of Biomarkers Associated With Bone, Muscle and Energy Metabolism
- ClinicalTrials.gov ID
- NCT07454252
- Acronym / sponsor ID
- OVAD / OVAD
- Conditions
- Bone Remodeling, Energy Metabolism
- Keywords
- Energy metabolism, Bone resorption markers (CTx-I, NTx-I, deoxypyridinoline/DPD), Bone turnover markers (BTMs), Statistical modeling of metabolic interactions
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 6 Mar 2026 (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.
Bone is a metabolically active tissue undergoing continuous remodeling through the coordinated actions of osteoclasts (resorption), osteoblasts (formation), and osteocytes (regulation). Under physiological conditions, bone formation and resorption are balanced and regulated by systemic hormones (PTH, vitamin D, estrogens) and local mediators. However, aging, metabolic disorders, physical inactivity, or pharmacological treatments may disrupt this equilibrium, leading to the predominance of one process over the other. Circulating biochemical markers of bone turnover-classified into formation markers (P1NP, osteocalcin, bone alkaline phosphatase) and resorption markers (CTx-I, NTx-I, DPD)-provide a means to monitor these dynamics.
Beyond its mechanical role, bone also functions as an endocrine organ: osteocalcin, secreted by osteoblasts, modulates insulin secretion and sensitivity, linking bone to muscle and adipose tissue in the regulation of energy metabolism. Adipokines such as leptin and adiponectin further contribute to this complex crosstalk. Bone biomarkers are therefore essential for evaluating skeletal metabolism and identifying conditions such as osteoporosis, though the strict classification into formation versus resorption markers is limited, as some (e.g., osteocalcin) reflect both processes.
This study aims to analyze IRCCS San Raffaele database records of urinary and serum biomarkers related to bone, muscle, and energy metabolism, to assess their trends and associations according to age and sex, and to develop statistical models capable of explaining their interrelationships.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OVAD cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (age > 18 years), both male and female (n = 1000), undergoing routine blood sampling, whose biological specimens (blood and/or urine) were analyzed at the Laboratory Medicine Service of IRCCS San Raffaele Hospital, Milan, between January 1, 2006 and March 31, 2025.
Key inclusion criteria (2 listed)
- Age > 18 years.
- Blood sampling performed at the Laboratory Medicine Service of IRCCS San Raffaele Hospital, Milan, between January 1, 2006 and March 31, 2025.
Key exclusion criteria (1 listed)
- -Age < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate circulating levels of osteocalcin, the main non-collagenous protein bound to hydroxyapatite (HAP) and synthesized by osteoblasts-thus considered a biomarker of bone formation-in relation to circulating vitamin D, an endocrine factor involved
Time frame: As a retrospective study, data were obtained from the San Raffaele Hospital database for the period January 1, 2016, to November 30, 2023, regardless of patients' therapeutic paths.
Osteocalcin data will be acquired, retrospectively, through the San Raffaele Hospital database from January 1st, 2016 to November 30th, 2023
1 secondary outcome
As a secondary outcomes biomarkers of bone formation and reabsorption as well as biomarkers of skeletal muscle and energy metabolism will be evaluated in order to gain insights on how different tissues can influence each other.
Time frame: As a retrospective study, data were obtained from the San Raffaele Hospital database for the period January 1, 2016, to November 30, 2023, regardless of patients' therapeutic paths.
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 6 Mar 2026.
- Individual participant dataSharing planned: No
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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 Remodeling and Energy Metabolism, run by IRCCS San Raffaele 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 2 inclusion and 1 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 6 Mar 2026. 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 Eleonora Sabetta, MD (0226435288, sabetta.eleonora@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate circulating levels of osteocalcin, the main non-collagenous protein bound to hydroxyapatite (HAP) and synthesized by osteoblasts-thus considered a biomarker of bone formation-in relation to circulating vitamin D, an endocrine factor involved (time frame: As a retrospective study, data were obtained from the San Raffaele Hospital database for the period January 1, 2016, to November 30, 2023, regardless of patients' therapeutic paths.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2026.