Retrospective Monocentric Evaluation of Biomarkers Associated With Bone, Muscle and Energy Metabolism
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Age < 18 years
研究组 & 干预措施
OVAD cohort
结局指标
主要结局
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
时间窗: 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
次要结局
- 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.)
研究者
Massimo Locatelli
Director
IRCCS San Raffaele
