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临床试验/NCT04470895
NCT04470895撤回不适用

Impact of Drugs on the Risk of Falls in the Fracture Department of the Paris Saint-Joseph

Fondation Hôpital Saint-Joseph0 个研究点开始时间: 2021年9月24日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Impact of drugs on Fracture Track Patients

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
45 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient aged between 45 and 95
  • French-speaking
  • Patient included in the GhPSJ fracture track, taking at least one long-term prescription medication and hospitalized in a GhPSJ department or in Léopold Bellan.

排除标准

  • Patient objecting to participation in the study
  • Patient who has recently moved or medical nomadism making it impossible to reconcile medication with a pharmacy
  • Patient not hospitalized or transferred to a hospital other than the GhPSJ or Léopold Bellan at the time of the fracture
  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under the safeguard of justice.

结局指标

主要结局

Impact of drugs on Fracture Track Patients

时间窗: July, 2020

The research aims at determining the impact of drug intake (number and type of drugs) on the occurrence of falls in patients hospitalized for an osteoporotic fracture.

次要结局

  • Frequency of falls on Fracture Track patients.(July, 2020)

研究者

申办方类型
Other
责任方
Sponsor

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