Retrospective Monocentric Evaluation of Biomarkers Associated With Bone, Muscle and Energy Metabolism

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.

Recruiting

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Key information

Conditions

Bone Remodeling Energy Metabolism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS San Raffaele Hospital

Milan, Italy, 20132

Location status: Recruiting

Location contact

Eleonora Sabetta, MD

CONTACT

[email protected]

+390226435288

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

-Age < 18 years

Treatment and study plan

Primary outcomes

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

Secondary outcomes

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.
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

Study contacts

Contact information is provided by the study sponsor or research team.

Eleonora Sabetta, MD

CONTACT

[email protected]

0226435288

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Acronym: OVAD

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2027
First posted: Mar 6, 2026
Registry last updated: Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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