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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07454252
Acronym
OVAD
Enrollment
1000
Registered
2026-03-06
Start date
2025-10-10
Completion date
2027-09-30
Last updated
2026-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Brief summary

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.

Interventions

None listed

Sponsors

IRCCS San Raffaele
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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 involvedAs 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

MeasureTime frameDescription
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.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

Countries

Italy

Contacts

CONTACTEleonora Sabetta, MD
sabetta.eleonora@hsr.it0226435288

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026