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| Name | Class |
|---|---|
| National Hellenic Research Foundation | OTHER |
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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.
Study Objectives:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Postmenopausal Female Patient with subcapital hip osteoporotic fracture | Postmenopausal Female Patient with subcapital hip osteoporotic fracture |
| |
| Postmenopausal Female Patient with hip osteoarthritis | Postmenopausal female patient with hip osteoarthritis who will undergo total hip replacement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone, Serum and Plasma sample | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Identification of Proteomic Biomarkers | The number of proteins identified through proteomic analysis that differ significantly between osteoporosis and control groups | Up to 18 months. |
| Identification of Metabolomic Biomarkers | The number of small molecules identified through metabolomic analysis that differ significantly between osteoporosis and control groups. | Up to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Bone Density Assessment | Bone density measurements using micro-CT in patients with osteoporosis and controls. | Up to 18 months |
| Identification of Disrupted Pathways | Analysis of disrupted biological pathways using bioinformatics tools to map the mechanisms affected in osteoporosis. |
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Inclusion Criteria:
Exclusion Criteria:
Only postmenopausal female patients
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Efstathios Chronopoulos | Contact | 00306944837793 | stathi24@yahoo.gr | |
| Stavros Lykos | Contact | 00306978695466 | lykosstavros@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Efstathios Chronopoulos | KAT General Hospital, Athens Greece | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratory for Research of the Musculoskeletal System | Recruiting | Kifissia | Attica | 14561 | Greece |
We plan to make individual participant data (IPD) available to other researchers upon reasonable request. Data sharing will be governed by ethical guidelines and privacy regulations to ensure the confidentiality and security of participant information. Interested researchers will be required to submit a formal request, including a brief proposal outlining the intended use of the data. Approved requests will gain access to anonymized data sets, ensuring that participant identities are protected. The aim is to foster collaborative research and maximize the scientific impact of our findings.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 10, 2024 | Jul 24, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| D058866 | Osteoporotic Fractures |
| D010024 | Osteoporosis |
| D010003 | Osteoarthritis |
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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Bone,Serum and Plasma
| Up to 18 months |
| Correlation of Omics Data with Clinical Markers | Correlation analysis between identified proteomic and metabolomic biomarkers and traditional clinical markers such as CTX and PINP. | Up to 18 months |
| Microarchitecture Assessment | Evaluation of bone microarchitecture using histological analysis in osteoporosis patients and controls. | Up to 18 months |
| D009750 |
| Nutritional and Metabolic Diseases |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D012216 | Rheumatic Diseases |
| D005264 | Femoral Fractures |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |