New Biomarkers and Therapeutic Targets in Osteoporosis Via Omics Technologies

National and Kapodistrian University of Athens

Status: Enrolling

Conditions: Osteoporosis, Severe; Osteoporosis Fracture; Osteoporosis, Postmenopausal

Treatments: Other: Bone, Serum and Plasma sample

Study type: Observational

Funder types: Other

Identifiers

NCT06525688

31274/03.07.2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

Postmenopausal Female Patient with subcapital hip osteoporotic fracture

Description:

Postmenopausal Female Patient with subcapital hip osteoporotic fracture

Treatment:

Other: Bone, Serum and Plasma sample

Postmenopausal Female Patient with hip osteoarthritis

Description:

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

Treatment:

Other: Bone, Serum and Plasma sample