Continuation of Anti-osteoporotic Treatment 1 Year After Initial Administration

Osteoporosis Fracture Clinical Trial

— POUROSTEO  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06024148
• Other study ID #: 38RC23.0179
• Status: Not yet recruiting
• Start date: September 2023
• Est. completion date: September 2024

Study information

• Verified date: August 2023
• Source: University Hospital, Grenoble
• Contact: Sabine DREVET, Dr
• Phone: 04 76 76 66 06
• Email: sdrevet[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: September 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis Fracture
• Osteoporotic Fractures

Intervention

Other:
• phone survey
patients complete a 10-minute telephone questionnaire on their osteoporosis management

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Medical records collected one year after Geriatric Rehabilitation Department stay
Secondary	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.	Telephone data collection one year after Geriatric Rehabilitation Department stay
Secondary	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.	Telephone data collection one year after Geriatric Rehabilitation Department stay
Secondary	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.	Telephone data collection one year after Geriatric Rehabilitation Department stay
Secondary	Evaluation of the professional practices of general practitioners concerning the management of osteoporosis.	Analysis of the results of the professional practice assessment questionnaire	Telephone data collection one year after Geriatric Rehabilitation Department stay of their patient