Clinical trial NCT06525688: New Biomarkers and Therapeutic Targets in Osteoporosis Via Omics Technologies
Official title: Identification of New Biomarkers and Potential Therapeutic Targets in Clinical Osteoporosis Using Omics Technologies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoporosis, Postmenopausal
Osteoporosis Fracture
Osteoporosis, Severe
Keywords: Osteoporosis
Osteoarthritis
Hip fracture
Postmenopausal Osteoporosis
Proteomics
Metabolomics
Osteoporotic Hip Fracture
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
Collaborators: name: National Hellenic Research Foundation
First posted: 2024-07-29
Enrollment: 60
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Identification of Proteomic Biomarkers
timeFrame: Up to 18 months.
measure: Identification of Metabolomic Biomarkers
timeFrame: Up to 18 months
Secondary outcomes:
measure: Bone Density Assessment
timeFrame: Up to 18 months
measure: Identification of Disrupted Pathways
timeFrame: Up to 18 months
measure: Correlation of Omics Data with Clinical Markers
timeFrame: Up to 18 months
measure: Microarchitecture Assessment
timeFrame: Up to 18 months
Other outcomes:
Locations:
city: Kifisiá
country: Greece
facility: Laboratory for Research of the Musculoskeletal System
state: Attica
Study officials:
affiliation: KAT General Hospital, Athens Greece
name: Efstathios Chronopoulos
role: STUDY_DIRECTOR
References: