Retrospective Monocentric Evaluation of Biomarkers Associated With Bone, Muscle and Energy Metabolism
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Bone Remodeling, Energy Metabolism. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- 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.]
Secondary outcome measures (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. [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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS San Raffaele Hospital — Milan
Identifiers
NCT: NCT07454252 · OVAD