New Biomarkers and Therapeutic Targets in Osteoporosis Via Omics Technologies
- Conditions
- Osteoporosis, PostmenopausalOsteoporosis, SevereOsteoporosis Fracture
- Interventions
- Other: Bone, Serum and Plasma sample
- Registration Number
- NCT06525688
- Lead Sponsor
- National and Kapodistrian University of Athens
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 60
- Postmenopausal Female Patients with osteoporotic subcapital femoral neck fracture (Arm 1)
- Postmenopausal Female Patients with hip osteoarthritis that will undergo Total Hip Replacement (Arm 2)
- Patients that have undergone before osteoporotic fractures
- Patients with severe cardiovascular, pulmonary, autoimmune, or urinary system conditions
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Postmenopausal Female Patient with hip osteoarthritis Bone, Serum and Plasma sample Postmenopausal female patient with hip osteoarthritis who will undergo total hip replacement. Postmenopausal Female Patient with subcapital hip osteoporotic fracture Bone, Serum and Plasma sample Postmenopausal Female Patient with subcapital hip osteoporotic fracture
- Primary Outcome Measures
Name Time Method Identification of Metabolomic Biomarkers Up to 18 months The number of small molecules identified through metabolomic analysis that differ significantly between osteoporosis and control groups.
Identification of Proteomic Biomarkers Up to 18 months. The number of proteins identified through proteomic analysis that differ significantly between osteoporosis and control groups
- Secondary Outcome Measures
Name Time Method Bone Density Assessment Up to 18 months Bone density measurements using micro-CT in patients with osteoporosis and controls.
Microarchitecture Assessment Up to 18 months Evaluation of bone microarchitecture using histological analysis in osteoporosis patients and controls.
Correlation of Omics Data with Clinical Markers Up to 18 months Correlation analysis between identified proteomic and metabolomic biomarkers and traditional clinical markers such as CTX and PINP.
Identification of Disrupted Pathways Up to 18 months Analysis of disrupted biological pathways using bioinformatics tools to map the mechanisms affected in osteoporosis.
Trial Locations
- Locations (1)
Laboratory for Research of the Musculoskeletal System
🇬🇷Kifisiá, Attica, Greece