Osteoporosis FracturePOUROSTEONCT06024148
Continuation of Anti-osteoporotic Treatment 1 Year After Initial Administration
An observational study of Osteoporosis Fracture, run by University Hospital, Grenoble.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Osteoporosis Fracture
- What is being tested?
- phone survey
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Sep 2024
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
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).
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
Magali ABADIE contact
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoporosis Fracture
- Being tested
- phone survey
- Keywords
- antiosteoporotic treatment, professional practice assessment
- Medical subject headings
- Osteoporotic Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phone surveyOther
patients complete a 10-minute telephone questionnaire on their osteoporosis management
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: phone survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Percentage of patients who received anti-osteoporosis treatment during their overall stay
Measured: Medical records collected one year after Geriatric Rehabilitation Department stay
Identify patient-related obstacles and levers to treatment renewal at 1 year after fracture
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.
Measured: 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.
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.
Measured: 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
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.
Measured: Telephone data collection one year after Geriatric Rehabilitation Department stay
Evaluation of the professional practices of general practitioners concerning the management of osteoporosis.
Analysis of the results of the professional practice assessment questionnaire
Measured: Telephone data collection one year after Geriatric Rehabilitation Department stay of their patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study startSep 2023 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis FractureStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024148
- Sponsor's protocol ID
- 38RC23.0179
- Acronym
- POUROSTEO
- Status last verified
- Aug 2023
- First submitted
- 17 Aug 2023
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06024148
- Acronym / sponsor ID
- POUROSTEO / 38RC23.0179
- Conditions
- Osteoporosis Fracture
- Keywords
- antiosteoporotic treatment, professional practice assessment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 6 Sep 2023 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients hospitalized in the Geriatric Rehabilitation Department | – | Other: phone surveypatients 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 |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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).
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| phone surveypatients complete a 10-minute telephone questionnaire on their osteoporosis management | Other | patients hospitalized in the Geriatric Rehabilitation Department |
Primary outcome
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)
5 secondary outcomes
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
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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.
Magali ABADIE contact
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis Fracture, run by University Hospital, Grenoble.
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 4 inclusion and 5 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 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Sabine DREVET, Dr (04 76 76 66 06, sdrevet@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 6 Sep 2023.