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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06525688
Enrollment
60
Registered
2024-07-29
Start date
2024-07-03
Completion date
2025-12-30
Last updated
2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis Fracture, Osteoporosis, Postmenopausal, Osteoporosis, Severe

Keywords

Osteoporosis, Osteoarthritis, Hip fracture, Postmenopausal Osteoporosis, Proteomics, Metabolomics, Osteoporotic Hip Fracture

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.

Interventions

OTHERBone, 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.

Sponsors

National Hellenic Research Foundation
CollaboratorOTHER
National and Kapodistrian University of Athens
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

* 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)

Exclusion criteria

* Patients that have undergone before osteoporotic fractures * Patients with severe cardiovascular, pulmonary, autoimmune, or urinary system conditions

Design outcomes

Primary

MeasureTime frameDescription
Identification of Proteomic BiomarkersUp to 18 months.The number of proteins identified through proteomic analysis that differ significantly between osteoporosis and control groups
Identification of Metabolomic BiomarkersUp to 18 monthsThe number of small molecules identified through metabolomic analysis that differ significantly between osteoporosis and control groups.

Secondary

MeasureTime frameDescription
Bone Density AssessmentUp to 18 monthsBone density measurements using micro-CT in patients with osteoporosis and controls.
Identification of Disrupted PathwaysUp to 18 monthsAnalysis of disrupted biological pathways using bioinformatics tools to map the mechanisms affected in osteoporosis.
Correlation of Omics Data with Clinical MarkersUp to 18 monthsCorrelation analysis between identified proteomic and metabolomic biomarkers and traditional clinical markers such as CTX and PINP.
Microarchitecture AssessmentUp to 18 monthsEvaluation of bone microarchitecture using histological analysis in osteoporosis patients and controls.

Countries

Greece

Contacts

Primary ContactEfstathios Chronopoulos
stathi24@yahoo.gr00306944837793
Backup ContactStavros Lykos
lykosstavros@gmail.com00306978695466

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026