New Biomarkers and Therapeutic Targets in Osteoporosis Via Omics Technologies

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

Study Overview

• Status: Recruiting
• Conditions: Osteoporosis, Postmenopausal; Osteoporosis Fracture; Osteoporosis, Severe
• Intervention / Treatment: Other: Bone, Serum and Plasma sample

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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Efstathios Chronopoulos; Phone Number: 00306944837793; Email: stathi24@yahoo.gr
• Study Contact Backup: Name: Stavros Lykos; Phone Number: 00306978695466; Email: lykosstavros@gmail.com

Study Locations

• Greece
  • Attica
    • Kifisiá, Attica, Greece, 14561
      • Recruiting
      • Laboratory for Research of the Musculoskeletal System
      • Contact: Efstathios Chronopoulos, Prof.; Phone Number: 00306944837793; Email: stathi24@yahoo.gr
      • Sub-Investigator: Stavros Lykos
      • Sub-Investigator: Kalliopi Lampropoulou-Adamidou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

• 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)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Postmenopausal Female Patient with subcapital hip osteoporotic fracture	Other: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: National and Kapodistrian University of Athens
• Collaborators: National Hellenic Research Foundation
• Investigators: Study Director: Efstathios Chronopoulos, KAT General Hospital, Athens Greece

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2024
• Primary Completion (Estimated): October 15, 2024
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: July 17, 2024
• First Submitted That Met QC Criteria: July 24, 2024
• First Posted (Actual): July 29, 2024

Study Record Updates

• Last Update Posted (Actual): July 29, 2024
• Last Update Submitted That Met QC Criteria: July 24, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Osteoarthritis; Metabolomics; Osteoporosis; Proteomics; Postmenopausal Osteoporosis; Hip fracture; Osteoporotic Hip Fracture
• Additional Relevant MeSH Terms: Metabolic Diseases; Fractures, Bone; Wounds and Injuries; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Osteoporosis, Postmenopausal; Osteoporotic Fractures
• Other Study ID Numbers: 31274/03.07.2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No