New Biomarkers and Therapeutic Targets in Osteoporosis Via Omics Technologies
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorNational and Kapodistrian University of Athens
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Patients that have undergone before osteoporotic fractures
Patients with severe cardiovascular, pulmonary, autoimmune, or urinary system conditions
Trial 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)
Trial design
Design model
Case-control
Time perspective
Retrospective
Treatments tested in this trial
Bone, Serum and Plasma sample
Other interventionIntervention: 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Postmenopausal Female Patient with subcapital hip osteoporotic fracture1 intervention
Group B: Postmenopausal Female Patient with hip osteoarthritis1 intervention
Trial outcomes
Primary outcomes
1
Identification of Proteomic Biomarkers
The number of proteins identified through proteomic analysis that differ significantly between osteoporosis and control groups
Time frame
Up to 18 months.2
Identification of Metabolomic Biomarkers
The number of small molecules identified through metabolomic analysis that differ significantly between osteoporosis and control groups.
Time frame
Up to 18 monthsSecondary outcomes
1
Bone Density Assessment
Bone density measurements using micro-CT in patients with osteoporosis and controls.
Time frame
Up to 18 months2
Identification of Disrupted Pathways
Analysis of disrupted biological pathways using bioinformatics tools to map the mechanisms affected in osteoporosis.
Time frame
Up to 18 months3
Correlation of Omics Data with Clinical Markers
Correlation analysis between identified proteomic and metabolomic biomarkers and traditional clinical markers such as CTX and PINP.
Time frame
Up to 18 months4
Microarchitecture Assessment
Evaluation of bone microarchitecture using histological analysis in osteoporosis patients and controls.
Time frame
Up to 18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
National and Kapodistrian University of Athens
Lead sponsor
National Hellenic Research Foundation
Collaborator
Source ClinicalTrials.gov