NCT06525688

New Biomarkers and Therapeutic Targets in Osteoporosis Via Omics Technologies

Identification of New Biomarkers and Potential Therapeutic Targets in Clinical Osteoporosis Using Omics Technologies

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: National and Kapodistrian University of Athens · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

This study aims to discover novel biomarkers and therapeutic targets for osteoporosis through the use of advanced omics technologies, including proteomics and metabolomics. By analyzing bone and plasma samples from patients with osteoporosis, the research seeks to understand the underlying mechanisms of the disease and identify potential diagnostic and therapeutic biomarkers.

Detailed description

Study Objectives: 1. To investigate the proteomic profile of bone and plasma in clinical osteoporosis compared to patients with osteoarthritis. 2. To study the metabolomic profile of serum in clinical osteoporosis compared to patients with osteoarthriti. 3. To identify and validate potential biomarkers for osteoporosis diagnosis and treatment. 4. To elucidate the pathophysiological mechanisms involved in osteoporosis. Methodology: Clinical Osteoporosis: Patient Recruitment: 60 postmenopausal women will be divided into two groups: those with osteoporotic hip fractures and a control group with osteoarthritis undergoing total hip replacement. Sample Collection: Bone Samples: Collected from the femoral neck during surgery, cleaned, and divided into four parts. One part will be used for bone density analysis (pQCT or DXA), and the other parts will be stored for proteomic analysis. Blood Samples: Fasting morning blood samples will be collected for general biochemical tests, bone turnover markers, and stored for metabolomic and proteomic analyses. Technologies and Analysis: Proteomics: Utilizes mass spectrometry to identify and quantify proteins in bone and plasma. Key pathways and protein networks involved in osteoporosis will be identified using bioinformatics tools. Metabolomics: Analyzes small molecules in serum to uncover metabolic changes associated with osteoporosis. Both targeted and non-targeted approaches will be used to identify significant biomarkers. Expected Outcomes: 1. Identification of specific proteins and metabolites as biomarkers for osteoporosis. 2. Enhanced understanding of the molecular mechanisms driving bone loss. 3. Validation of therapeutic targets for potential treatment strategies. Significance: This integrative approach combining proteomics and metabolomics aims to provide a comprehensive understanding of osteoporosis, facilitating the development of more accurate diagnostic tools and effective treatments for this widespread bone disease.

Conditions

• Osteoporosis, Postmenopausal
• Osteoporosis Fracture
• Osteoporosis, Severe

Interventions

Type	Name	Description
OTHER	Bone, Serum and Plasma sample	Intervention: Bone samples will be collected during surgery from the femoral neck (which is typically removed and discarded in these operations) and fasting morning blood samples.

Timeline

• Start date: 2024-07-03
• Primary completion: 2024-10-15
• Completion: 2025-12-30
• First posted: 2024-07-29
• Last updated: 2024-07-29

Locations

1 site across 1 country: Greece