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临床试验/NCT07169669
NCT07169669尚未招募不适用

Multicentre Longitudinal Study of Bone Mineralisation Characteristics in Marfan Syndrome and Ehlers-Danlos Syndrome

IRCCS Policlinico S. Donato0 个研究点目标入组 150 人开始时间: 2025年10月31日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
150
主要终点
Objective 1

研究概览

简要总结

The general objective of this research is to evaluate the characteristics of bone mineralisation in patients with Marfan syndrome or Ehlers-Danlos syndrome on a large case series.

In particular we intend to obtain data regarding the characteristics of bone mineralisation, as well as their variation over time and the relationships existing with other clinical-anamnestic parameters, in patients with Marfan syndrome or Ehlers-Danlos syndrome by retrospectively analysing (data already collected for normal clinical practice and already available at the hospital) the case history of the Cardiovascular genetic center at IRCCS Policlinico San Donato and the related Computerized Bone Mineralometry (MOC) examinations performed at the Radiology Service of the same hospital between 1 September 2019 and 31 December 2022.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Subjects with Marfan syndrome and Ehlers-Danlos syndrome according to the revised reference criteria belonging to the Cardiovascular genetic center at IRCCS Policlinico San Donato and the Reference Centre for Ehlers-Danlos Syndromes Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico;
  • Adult and paediatric subjects who have performed at least one Bone Mineral Densitometry within the observation period of the study.

排除标准

  • Presence of prostheses in the spinal column;
  • Presence of prostheses in the coxofemoral joint;
  • Oncological bone diseases reported in history.

结局指标

主要结局

Objective 1

时间窗: Between 1 September 2019 and 31 January 2025.

To retrospectively evaluate the percentage of subjects with fractures in subjects with Marfan syndrome and Ehlers Danlos syndrome who performed at least one Bone Mineral Densitometry in the period between 1 September 2019 and 31 January 2025.

次要结局

  • Objective 2(Between 1 September 2019 and 31 January 2025.)
  • Objective 3(Between 1 September 2019 and 31 January 2025.)
  • Objective 4(Between 1 September 2019 and 31 January 2025.)

研究者

发起方
IRCCS Policlinico S. Donato
申办方类型
Other
责任方
Sponsor

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