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NCT Number: NCT06525688

New Biomarkers and Therapeutic Targets in Osteoporosis Via Omics Technologies

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.

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

Laboratory for Research of the Musculoskeletal System

Kifissia, Attica, 14561, Greece

Location status: Recruiting

Location contact

Efstathios Chronopoulos, Prof.

CONTACT

[email protected]

00306944837793

Kalliopi Lampropoulou-Adamidou

SUB_INVESTIGATOR

Stavros Lykos

SUB_INVESTIGATOR

About this study

Study Objectives:

  • To investigate the proteomic profile of bone and plasma in clinical osteoporosis compared to patients with osteoarthritis.
  • To study the metabolomic profile of serum in clinical osteoporosis compared to patients with osteoarthriti.
  • To identify and validate potential biomarkers for osteoporosis diagnosis and treatment.
  • 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:

  • Identification of specific proteins and metabolites as biomarkers for osteoporosis.
  • Enhanced understanding of the molecular mechanisms driving bone loss.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Identification of Proteomic Biomarkers

    Time frame: Up to 18 months.

    The number of proteins identified through proteomic analysis that differ significantly between osteoporosis and control groups

  2. Identification of Metabolomic Biomarkers

    Time frame: Up to 18 months

    The number of small molecules identified through metabolomic analysis that differ significantly between osteoporosis and control groups.

Secondary outcomes

  1. Bone Density Assessment

    Time frame: Up to 18 months

    Bone density measurements using micro-CT in patients with osteoporosis and controls.

  2. Identification of Disrupted Pathways

    Time frame: Up to 18 months

    Analysis of disrupted biological pathways using bioinformatics tools to map the mechanisms affected in osteoporosis.

  3. Correlation of Omics Data with Clinical Markers

    Time frame: Up to 18 months

    Correlation analysis between identified proteomic and metabolomic biomarkers and traditional clinical markers such as CTX and PINP.

  4. Microarchitecture Assessment

    Time frame: Up to 18 months

    Evaluation of bone microarchitecture using histological analysis in osteoporosis patients and controls.

Study contacts

Contact information is provided by the study sponsor or research team.

Efstathios Chronopoulos

CONTACT

[email protected]

00306944837793

Stavros Lykos

CONTACT

[email protected]

00306978695466

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Collaborators

  • National Hellenic Research Foundation

Registry information

Official study title

Identification of New Biomarkers and Potential Therapeutic Targets in Clinical Osteoporosis Using Omics Technologies

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 29, 2024
Registry last updated
Jul 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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