Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT04470895 |
| Other study ID # |
MEDI-CHUTE |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 24, 2021 |
| Est. completion date |
September 24, 2021 |
Study information
| Verified date |
January 2022 |
| Source |
Groupe Hospitalier Paris Saint Joseph |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Falls of the elderly are a public health problem that have been neglected for too long. The
experience of a fall makes the elderly person vulnerable, even in the absence of traumatic
consequences, and can sometimes be a reason for institutionalization. These falls are
frequent and have many repercussions on the autonomy of seniors. According to data from the
National Institute for Prevention and Health Education (INPES), falls are the leading cause
of accidental death among people over 65 years of age. They cause approximately 8,500 deaths
per year. After the age of 65, one person in three falls at least once a year. They account
for 10% of the reasons for consultation and 12% of hospitalizations in geriatric settings
among the elderly. The risk increases with age because 80% of people over 85 years of age
fall at least once a year. 20 to 30% of people over 65 have a loss or decrease in autonomy
after a fall. The risk of another fall is twenty times higher after a first fall and the risk
of death increases especially in the year following the fall. This is of major importance
because falls are responsible for the majority of fractures in the elderly, especially
femoral neck fractures. The cost of falls among the elderly is significant and estimated at 2
billion euros for communities.
Description:
The causes of falls are multiple and the imputability of medication is often mentioned. In
fact, physiological or pathological ageing, which often justifies an intensification of drug
use, leads to polymedication, which is recognised as a risk factor for falls in the elderly
and generates dosage regimens that are most often complex and which are a source of drug
over- or under-dosage. Thus, a large number of treatments increase the risk of drug
interactions, particularly of a pharmacokinetic nature, which may lead to drug overdoses,
while poor compliance with prescriptions may lead to underdoses. The main classes of drugs
currently attributed to the risk of falls are psychotropic drugs, sleeping pills and
tranquillizers, antidepressants, cardiovascular drugs, antiepileptics, hypoglycemic drugs and
drugs that cause orthostatic hypotension such as antihypertensives.
Screening for risk factors for falls is an important step in management. The recommendations
drawn up by the Société Française de Documentation et de Recherche en Médecine Générale
(SFDRMG), in partnership with the Haute Autorité de Santé (HAS), suggest specifying the
relevant interventions, both medicinal and non-pharmaceutical, to avoid an initial fall
(indications, necessary means, interactions between the interveners).
Osteoporosis is a diffuse skeletal disease characterized by low bone mass and deterioration
of the micro-architecture of bone tissue, responsible for an increased risk of fracture. The
prevention of osteoporotic fractures is essential and involves screening and treatment of
osteoporosis but also the prevention of falls. New care pathways have been developed in
recent years, in particular the Fractures Liaisons Services to improve the management of this
pathology.
Fracture Pathways (in English: Fractures Liaisons Services: FLS), so called because of the
need for a link between the services concerned by this pathology (emergency, orthopaedic
surgery, rheumatology, sometimes geriatrics), aim to identify, screen and, if necessary,
treat patients with osteoporosis.
Within the Paris Saint-Joseph Hospital Group (GhSPJ), the OPTIPOST study (OPTImisation de la
Prise en Charge de l'OSTéoporose chez des sujets de plus de 45 ans) highlighted the benefits
of "reinforced" management of patients with osteoporotic fractures of the upper end of the
femur (ESF) or the lower end of the radius (EIR) via a specific organisation coordinated by
an IDE between 2014 and 2015.
This is why, following these results, and in the continuity of OPTIPOST, a Fracture Track has
been set up at the GhPSJ. This is a new organisation dedicated to the management of fractured
osteoporosis, independent of OPTIPOST, based on the census and follow-up of patients aged 45
to 95 years old admitted to the emergency reception service (UAS) for any kind of
osteoporotic fracture. The main objective of this approach is the management of fractured
osteoporosis. Patients included in this line are counted by the nurse coordinator on D0 and
are questioned by telephone within 2 months following the fracture to ensure that the
osteoporosis is being managed.
Currently, the Fracture Track does not take into account the risk factors for falls in
osteoporotic fractured patients, in particular the risk of falls due to medication, hence the
aim of this work.
