Osteoporosis, PostmenopausalNCT06525688
New Biomarkers and Therapeutic Targets in Osteoporosis Via Omics Technologies
An observational study of Osteoporosis, Postmenopausal and Osteoporosis Fracture, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Osteoporosis, Postmenopausal, Osteoporosis Fracture, Osteoporosis, Severe
- What is being tested?
- Bone, Serum and Plasma sample
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 3 Jul 2024to 30 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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)
Who may be able to join
- 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)
Who cannot join
- Patients that have undergone before osteoporotic fractures
- Patients with severe cardiovascular, pulmonary, autoimmune, or urinary system conditions
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Laboratory for Research of the Musculoskeletal System
Kifissia, Attica, 14561
Efstathios Chronopoulos, Prof., 00306944837793, stathi24@yahoo.gr
Stavros Lykos
About this study
Official title: 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.
Read the detailed description
Study Objectives:
- To investigate the proteomic profile of bone and plasma in clinical osteoporosis compared to patients with osteoarthritis.
- To study the metabolomic profile of serum in clinical osteoporosis compared to patients with osteoarthriti.
- To identify and validate potential biomarkers for osteoporosis diagnosis and treatment.
- 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:
- Identification of specific proteins and metabolites as biomarkers for osteoporosis.
- Enhanced understanding of the molecular mechanisms driving bone loss.
- 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.
- Being tested
- Bone, Serum and Plasma sample
- Keywords
- Osteoporosis, Osteoarthritis, Hip fracture, Postmenopausal Osteoporosis, Proteomics, Metabolomics, Osteoporotic Hip Fracture
- Medical subject headings
- Osteoporosis, Postmenopausal, Osteoporotic Fractures, Osteoporosis, Osteoarthritis, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone, Serum and Plasma sampleOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Postmenopausal Female Patient with subcapital hip osteoporotic fracture | Postmenopausal Female Patient with subcapital hip osteoporotic fracture Receives: Other: Bone, Serum and Plasma sample | |
| Postmenopausal Female Patient with hip osteoarthritis | Postmenopausal female patient with hip osteoarthritis who will undergo total hip replacement. Receives: Other: Bone, Serum and Plasma sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of Proteomic Biomarkers
The number of proteins identified through proteomic analysis that differ significantly between osteoporosis and control groups
Measured: 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.
Measured: Up to 18 months
Secondary outcomes (4)
Bone Density Assessment
Bone density measurements using micro-CT in patients with osteoporosis and controls.
Measured: Up to 18 months
Identification of Disrupted Pathways
Analysis of disrupted biological pathways using bioinformatics tools to map the mechanisms affected in osteoporosis.
Measured: 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.
Measured: Up to 18 months
Microarchitecture Assessment
Evaluation of bone microarchitecture using histological analysis in osteoporosis patients and controls.
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start3 Jul 2024
- Primary completion15 Oct 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Collaborators
- National Hellenic Research Foundation
- Responsible party
- Principal investigator, EFSTATHIOS CHRONOPOULOS, National and Kapodistrian University of Athens
- Investigators
- Efstathios Chronopoulos, Study director, KAT General Hospital, Athens Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525688
- Sponsor's protocol ID
- 31274/03.07.2024
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of New Biomarkers and Potential Therapeutic Targets in Clinical Osteoporosis Using Omics Technologies
- ClinicalTrials.gov ID
- NCT06525688
- Acronym / sponsor ID
- 31274/03.07.2024
- Keywords
- Osteoporosis, Osteoarthritis, Hip fracture, Postmenopausal Osteoporosis, Proteomics, Metabolomics, Osteoporotic Hip Fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Collaborators
- National Hellenic Research Foundation
- Study start
- 3 Jul 2024 (actual)
- Primary completion
- 15 Oct 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To investigate the proteomic profile of bone and plasma in clinical osteoporosis compared to patients with osteoarthritis.
- To study the metabolomic profile of serum in clinical osteoporosis compared to patients with osteoarthriti.
- To identify and validate potential biomarkers for osteoporosis diagnosis and treatment.
- 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:
- Identification of specific proteins and metabolites as biomarkers for osteoporosis.
- Enhanced understanding of the molecular mechanisms driving bone loss.
- 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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postmenopausal Female Patient with subcapital hip osteoporotic fracture | – | Other: Bone, Serum and Plasma samplePostmenopausal Female Patient with subcapital hip osteoporotic fracture |
| Postmenopausal Female Patient with hip osteoarthritis | – | Other: Bone, Serum and Plasma samplePostmenopausal female patient with hip osteoarthritis who will undergo total hip replacement. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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)
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- Patients that have undergone before osteoporotic fractures
- Patients with severe cardiovascular, pulmonary, autoimmune, or urinary system conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone, Serum and Plasma sampleIntervention: 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. | Other | Postmenopausal Female Patient with hip osteoarthritis, Postmenopausal Female Patient with subcapital hip osteoporotic fracture |
Primary outcome
Identification of Proteomic Biomarkers
Time frame: Up to 18 months.
The number of proteins identified through proteomic analysis that differ significantly between osteoporosis and control groups
Identification of Metabolomic Biomarkers
Time frame: Up to 18 months
The number of small molecules identified through metabolomic analysis that differ significantly between osteoporosis and control groups.
4 secondary outcomes
Bone Density Assessment
Time frame: Up to 18 months
Identification of Disrupted Pathways
Time frame: Up to 18 months
Correlation of Omics Data with Clinical Markers
Time frame: Up to 18 months
Microarchitecture Assessment
Time frame: Up to 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Efstathios Chronopoulos study director
KAT General Hospital, Athens Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, Postmenopausal and Osteoporosis Fracture, run by National and Kapodistrian University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Efstathios Chronopoulos (00306944837793, stathi24@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of Proteomic Biomarkers (time frame: Up to 18 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024; AzTrials last refreshed its copy on 8 Nov 2026.