Continuation of Anti-osteoporotic Treatment 1 Year After Initial Administration (POUROSTEO)

August 28, 2023 updated by: University Hospital, Grenoble

Evaluation of the Continuation of Anti-osteoporotic Treatment 1 Year After Initial Administration Following Severe Osteoporotic Fracture in Patients Aged 75 and Over, Hospitalized at the Rocheplane Medical Center

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Selection of patients hospitalized at the Rocheplane Medical Center between June 2021 and May 2022, following a severe osteoporotic fracture and having received a first dose of antiosteoporotic treatment during their overall stay (initial admission department + CMR).

Sending of an information letter and request for non-objection from patients or their trusted support person, with a 1-month cooling-off period to express opposition.

Collection of variables of interest from CMR patients' medical records, followed by administration of a telephone hetero-questionnaire (transferred to Excel) to patients or their families 1 year after fracture occurrence.

If the patient or family did not answer the questionnaire, or if it was incomplete (missing data), the information could be sought by telephone from the attending physician.

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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).

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  • 1-year follow-up made impossible by lack of contact with patient, family or attending physician.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
patients complete a 10-minute telephone questionnaire on their osteoporosis management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Telephone data collection one year after Geriatric Rehabilitation Department stay
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the rate of introduction of anti-osteoporotic treatment during the patient's overall stay
Time Frame: Medical records collected one year after Geriatric Rehabilitation Department stay
Percentage of patients who received anti-osteoporosis treatment during their 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
Time Frame: Telephone data collection one year after Geriatric Rehabilitation Department stay
Percentage of patients presenting: a contraindication to treatment, intolerance to treatment, refusal of treatment, non-adherence to treatment, failure to consult their GP, forgetfulness, death.
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.
Time Frame: Telephone data collection one year after Geriatric Rehabilitation Department stay
Percentage of GPs reporting: unfamiliarity with the introduction of treatment at the time of fracture, unfamiliarity with how to prescribe treatment, unfamiliarity with "osteoporosis" recommendations, non-prescribing for fear of adverse effects (iatrogenicity), non-prescribing based on a judgement of an unfavourable benefit/risk balance, feeling of incompetence regarding the management of osteoporosis, lack of time, proposing therapeutic alternatives, forgetfulness.
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
Time Frame: Telephone data collection one year after Geriatric Rehabilitation Department stay
Absence of clear follow-up instructions on upstream department reports (quality of inter-professional communication), Absence of consultation with a rheumatologist, Absence of consultation with a geriatrician, Difficulty accessing a dental consultation, Absence of BMD, Cost of medication, Existence of a doctor-pharmacist link, GP cooperation with a network of well-identified specialists.
Telephone data collection one year after Geriatric Rehabilitation Department stay
Evaluation of the professional practices of general practitioners concerning the management of osteoporosis.
Time Frame: Telephone data collection one year after Geriatric Rehabilitation Department stay of their patient
Analysis of the results of the professional practice assessment questionnaire
Telephone data collection one year after Geriatric Rehabilitation Department stay of their patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

August 17, 2023

First Submitted That Met QC Criteria

August 28, 2023

First Posted (Estimated)

September 6, 2023

Study Record Updates

Last Update Posted (Estimated)

September 6, 2023

Last Update Submitted That Met QC Criteria

August 28, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC23.0179

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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