New Biomarkers and Therapeutic Targets in Osteoporosis Via Omics Technologies
NCT ID: NCT06525688
Last Updated: 2024-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
60 participants
OBSERVATIONAL
2024-07-03
2025-12-30
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Postmenopausal Female Patient with subcapital hip osteoporotic fracture
Postmenopausal Female Patient with subcapital hip osteoporotic fracture
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.
Postmenopausal Female Patient with hip osteoarthritis
Postmenopausal female patient with hip osteoarthritis who will undergo total hip replacement.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Postmenopausal Female Patients with hip osteoarthritis that will undergo Total Hip Replacement (Arm 2)
Exclusion Criteria
* Patients with severe cardiovascular, pulmonary, autoimmune, or urinary system conditions
FEMALE
No
Sponsors
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National Hellenic Research Foundation
OTHER
National and Kapodistrian University of Athens
OTHER
Responsible Party
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EFSTATHIOS CHRONOPOULOS
Professor in Orthopedics at National and Kapodistrian University of Athens, Laboratory for Research of the Musculoskeletal System Director
Principal Investigators
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Efstathios Chronopoulos
Role: STUDY_DIRECTOR
KAT General Hospital, Athens Greece
Locations
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Laboratory for Research of the Musculoskeletal System
Kifissia, Attica, Greece
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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31274/03.07.2024
Identifier Type: -
Identifier Source: org_study_id
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