New Biomarkers and Therapeutic Targets in Osteoporosis Via Omics Technologies

NCT ID: NCT06525688

Last Updated: 2024-07-29

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-03

Study Completion Date

2025-12-30

Brief Summary

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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.

Detailed Description

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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

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Osteoporosis, Postmenopausal Osteoporosis Fracture Osteoporosis, Severe

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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 Type 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.

Postmenopausal Female Patient with hip osteoarthritis

Postmenopausal female patient with hip osteoarthritis who will undergo total hip replacement.

Bone, Serum and Plasma sample

Intervention Type 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.

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.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Hellenic Research Foundation

OTHER

Sponsor Role collaborator

National and Kapodistrian University of Athens

OTHER

Sponsor Role lead

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

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Efstathios Chronopoulos

Role: CONTACT

00306944837793

Stavros Lykos

Role: CONTACT

00306978695466

Facility Contacts

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Efstathios Chronopoulos, Prof.

Role: primary

00306944837793

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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31274/03.07.2024

Identifier Type: -

Identifier Source: org_study_id

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