NCT05233072

Brief Summary

Society faces a major challenge with the management of the health and socio-economic burden caused by acute physical stress in the older population (\>75 years). In particular, hip fracture (HF) represents a major health care preoccupation, affecting 1.6 M patients worldwide, resulting in a significant drop of life quality and autonomy. Nowadays, this trauma is still associated with a poor outcome of 20-30% one-year mortality in the elderly. This emphasizes the value of assessing biological factors that may predict clinical outcome after HF. The preliminary work pinpoints a central role of neopterin in loss of autonomy and death. Using HF as an acute stress model that accelerates the progressive course of aging, the aim is to validate neopterin as a predictive biomarker of pernicious clinical outcomes.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

May 16, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2024

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

February 17, 2025

Status Verified

February 1, 2025

Enrollment Period

2.5 years

First QC Date

December 6, 2021

Last Update Submit

February 13, 2025

Conditions

Fracture of Neck of FemurResumption of Walking

Keywords

Neopterin

Outcome Measures

Primary Outcomes (1)

  • Resumption of walking with or without help

    Speed walk over 4 meters

    Day 30

Secondary Outcomes (7)

  • Short Physical Performance Battery score

    Day 30

  • Hand-grip test

    Day 30

  • Measurement of bioimpedancemetry

    Day 30

  • Activity of Daily Living score

    Day 30

  • Medical Outcome Study Short Form 12

    Day 30

  • +2 more secondary outcomes

Study Arms (2)

Fracture

OTHER

Patients with a fracture of the upper neck of the femur

Other: Blood sample

Control

OTHER

Patients with no fracture of the upper neck of the femur

Other: Blood sample

Interventions

Blood sampleOTHER

Arm 'Fracture':1 blood sample at D0, D1, D3, D7 and D30 Arm 'Control': 1 blood sample at D0

ControlFracture

Eligibility Criteria

Age75 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • For both arms:
  • age over 75
  • affiliated to health insurance system
  • written informed consent
  • For arm 'Fracture':
  • patient with a fracture of the upper neck of the femur
  • hospitalized in emergency in a 'UPOG' unit
  • For arm 'control':
  • hospitalized patient without any acute clinical event

You may not qualify if:

  • For both arms:
  • polytrauma
  • pathological bone or prothesis fracture
  • patient affiliated to 'Aide Médical de l'Etat - AME' insurance
  • patient with immunosuppressant treatment (including corticotherapy over 5 mg/d)
  • patient with active solid cancer or malignant haemopathy
  • patient with auto-immune disease
  • refusal to participate in research
  • For arm 'Fracture':
  • patient under justice protection measure except tutorship and guardianship
  • For arm 'control':
  • severe neurocognitive disorders (MMS \< 15)
  • fracture of the upper neck of the femur in the last year
  • patient under justice protection measure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GH Pitié-Salpêtrière / Service de gériatrie

Paris, Île-de-France Region, 75013, France

Location

MeSH Terms

Conditions

Femoral Neck Fractures

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Jacques BODDAERT, MD

    GH Pitié Salpêtrière - Charles Foix

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2021

First Posted

February 10, 2022

Study Start

May 16, 2022

Primary Completion

November 15, 2024

Study Completion

September 1, 2025

Last Updated

February 17, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)