NCT06024148

Brief Summary

The aim of this observational study is to assess the obstacles and levers to the continuation of anti-osteoporotic treatment, and to identify those where action could be taken to improve the quality of care for fractured patients. The individual and collective stakes are high. Fracture is the most feared complication of osteoporosis. The current under-diagnosis and under-treatment of this chronic pathology exposes patients to a high risk of early re-fracture, with the associated morbidity and mortality. General practitioners have a major role to play in monitoring and coordinating patients' healthcare pathways. The aim of this study is to assess ways of improving osteoporosis management in order to improve quality of life and disability-free life expectancy for individual patients. The public health and economic stakes are equally high. It is by identifying the obstacles that prospective work on the key elements to be implemented could help optimize osteoporosis management.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

August 17, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 6, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

September 6, 2023

Status Verified

August 1, 2023

Enrollment Period

5 months

First QC Date

August 17, 2023

Last Update Submit

August 28, 2023

Conditions

Keywords

antiosteoporotic treatmentprofessional practice assessment

Outcome Measures

Primary Outcomes (1)

  • Evaluate the rate of continuation of anti-osteoporotic treatment at 1 year after initial administration following a severe osteoporotic fracture in patients aged 75 and over.

    Percentage of patients for whom anti-osteoporosis treatment was renewed 1 year after initial administration (between fracture occurrence and discharge from the geriatric department)

    Telephone data collection one year after Geriatric Rehabilitation Department stay

Secondary Outcomes (5)

  • Determine the rate of introduction of anti-osteoporotic treatment during the patient's overall stay

    Medical records collected one year after Geriatric Rehabilitation Department stay

  • Identify patient-related obstacles and levers to treatment renewal at 1 year after fracture

    Telephone data collection one year after Geriatric Rehabilitation Department stay

  • Determine the obstacles and levers to the continuation of treatment at 1 year after a fracture, in relation to the treating physician.

    Telephone data collection one year after Geriatric Rehabilitation Department stay

  • Determine the obstacles and levers to the continuation of treatment at 1 year for fractures related to the healthcare system

    Telephone data collection one year after Geriatric Rehabilitation Department stay

  • Evaluation of the professional practices of general practitioners concerning the management of osteoporosis.

    Telephone data collection one year after Geriatric Rehabilitation Department stay of their patient

Study Arms (1)

patients hospitalized in the Geriatric Rehabilitation Department

patients aged 75 and over, admitted with a severe osteoporotic post-fracture, having received a first dose of antiosteoporotic treatment between the day of fracture and discharge from Geriatric Rehabilitation Department

Other: phone survey

Interventions

patients complete a 10-minute telephone questionnaire on their osteoporosis management

patients hospitalized in the Geriatric Rehabilitation Department

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We will include the number of patients corresponding to the "patient flow" admitted to CMR's units of interest over one year, and, corresponding to the inclusion criteria (CMR welcomes 250 patients aged 75 and over to its geriatric units each year, all types of fractures combined; ¾ of patients are admitted for severe fractures).

You may qualify if:

  • Hospitalization in CMR's Geriatric Rehabilitation Department between 01/06/2021 and 31/05/2022
  • Age: 75 and over
  • Admitted with severe post-fracture osteoporosis
  • Having received a first dose of antiosteoporotic treatment between the day the fracture occurred and discharge from CMR (either in an inpatient unit prior to CMR, or at CMR)

You may not qualify if:

  • Having objected to the use of his/her data for research purposes
  • Subject under guardianship or deprived of liberty.
  • Pathological fracture
  • Anti-osteoporotic treatment prior to fracture
  • year follow-up made impossible by lack of contact with patient, family or attending physician.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoporotic Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Central Study Contacts

Magali ABADIE

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2023

First Posted

September 6, 2023

Study Start

September 1, 2023

Primary Completion

February 1, 2024

Study Completion

September 1, 2024

Last Updated

September 6, 2023

Record last verified: 2023-08