NCT06525688

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 3, 2024

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 29, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2024

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

July 29, 2024

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

July 17, 2024

Last Update Submit

July 24, 2024

Conditions

Osteoporosis, PostmenopausalOsteoporosis FractureOsteoporosis, Severe

Keywords

OsteoporosisOsteoarthritisHip fracturePostmenopausal OsteoporosisProteomicsMetabolomicsOsteoporotic Hip Fracture

Outcome Measures

Primary Outcomes (2)

  • Identification of Proteomic Biomarkers

    The number of proteins identified through proteomic analysis that differ significantly between osteoporosis and control groups

    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.

    Up to 18 months

Secondary Outcomes (4)

  • Bone Density Assessment

    Up to 18 months

  • Identification of Disrupted Pathways

    Up to 18 months

  • Correlation of Omics Data with Clinical Markers

    Up to 18 months

  • Microarchitecture Assessment

    Up to 18 months

Study Arms (2)

Postmenopausal Female Patient with subcapital hip osteoporotic fracture

Postmenopausal Female Patient with subcapital hip osteoporotic fracture

Other: Bone, Serum and Plasma sample

Postmenopausal Female Patient with hip osteoarthritis

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

Other: Bone, Serum and Plasma sample

Interventions

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.

Postmenopausal Female Patient with hip osteoarthritisPostmenopausal Female Patient with subcapital hip osteoporotic fracture

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly postmenopausal female patients
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • 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)

You may not qualify if:

  • Patients that have undergone before osteoporotic fractures
  • Patients with severe cardiovascular, pulmonary, autoimmune, or urinary system conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory for Research of the Musculoskeletal System

Kifissia, Attica, 14561, Greece

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Bone,Serum and Plasma

MeSH Terms

Conditions

Osteoporosis, PostmenopausalOsteoporotic FracturesOsteoporosisOsteoarthritisHip Fractures

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesFractures, BoneWounds and InjuriesArthritisJoint DiseasesRheumatic DiseasesFemoral FracturesHip InjuriesLeg Injuries

Study Officials

  • Efstathios Chronopoulos

    KAT General Hospital, Athens Greece

    STUDY DIRECTOR

Central Study Contacts

Efstathios Chronopoulos

CONTACT

00306944837793stathi24@yahoo.gr

Stavros Lykos

CONTACT

00306978695466lykosstavros@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Orthopedics at National and Kapodistrian University of Athens, Laboratory for Research of the Musculoskeletal System Director

Study Record Dates

First Submitted

July 17, 2024

First Posted

July 29, 2024

Study Start

July 3, 2024

Primary Completion

October 15, 2024

Study Completion

December 30, 2025

Last Updated

July 29, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

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.

Locations

GR(1)