Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06525688
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
New Biomarkers and Therapeutic Targets in Osteoporosis Via Omics Technologies
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Identification of New Biomarkers and Potential Therapeutic Targets in Clinical Osteoporosis Using Omics Technologies
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None