Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06024148
Other study ID # 38RC23.0179
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT03710889 - Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption Phase 3
Recruiting NCT05058976 - Romosozumab Use to Build Skeletal Integrity Phase 4
Completed NCT03798444 - Height Loss, Kyphosis Indicators, Bone Mineral Density and Vertebral Fractures in Chinese Postmenopausal Women
Completed NCT04960033 - Evaluating Fracture Risk Assessment Tools (FRAX) From Different Regions in Central South Chinese Postmenopausal Women
Not yet recruiting NCT04597931 - Evaluation of Romosozumab vs. Zoledronic Acid Effect in Patients With Spinal Cord Injury and Low Bone Mineral Density Phase 4
Completed NCT05366621 - Post-fracture Medication and Mortality
Completed NCT02483286 - Osteoporosis and Fall Prevention With Multiple Interventions in the Metropolitan Area N/A
Enrolling by invitation NCT03178799 - Randomized Fracture Liaison Services
Completed NCT02803190 - Osteoporosis and Fall Prevention and Posture Correction Interventions in the Metropolitan Area N/A
Recruiting NCT03451305 - Postrual Reduction With Pillow in Osteoporotic Vertebral Fracture N/A
Recruiting NCT03811509 - Breast Cancer Women on Aromatase Inhibitors Treatment Phase 4
Recruiting NCT06379243 - Development and Validation of a Postoperative Re-fracture Risk Model for Osteoporotic Spinal Fractures N/A