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Идёт набор NCT02958020

Multicenter Cohort Study on Osteoporosis

— Наблюдательное Osteoporosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Osteoporosis. Базовые параметры: 45 лет — 79 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Multicenter Cohort Study on Osteoporosis in the Middle-aged and Elderly People in Shanghai, China

Обзор

This is a multicenter cohort study on osteoporosis in nine cities of China which locate in the east, south, north, west, middle of China. At least 3000 middle-aged and elderly permanent residents (women aged from 45 to 79, and men aged from 50 to 79) in every city will be enrolled. Residents with severe mental diseases, physical diseases or acute infectious diseases who could not cooperate with the survey as well as lactating or pregnant women were excluded. All the enrolled residents who signed informed consent will finish questionnaire including demographic characteristics, history of smoking, alcohol drinking, falls and fracture, family genetic history, chronic diseases and medicine,diary and physical practice，stool and urine status. Osteoporosis risk, health status, constitution of traditional Chinese medicine (TCM),symptoms of kidney yang deficiency in TCM，living environment,sweating status will be evaluated. Fasting blood glucose test and other blood tests for liver and kidney function,bone metabolism，vitamins，vitamin D metabolism and transportation as well as calcium and phosphate metabolism, will be performed. Bone mineral density and physical examinations (height, weight, waist circumference, hip circumference,grip,sit-to-stand test, tongue coating and pulse) will also be performed at enrollment and every two years after enrollment. DNA of blood cells will be preserved for specific study such as SNP analyses.Tongue coating and feces will be preserved for microflora analyses.

Первичные конечные точки

  • changes in bone mineral density from baseline to 2, 4, 6, 8 and 10 years after enrollment [Срок оценки: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment]
Вторичные конечные точки (11)
  • fracture questionnaire [Срок оценки: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment]
  • serum osteocalcin [Срок оценки: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment]
  • serum procollagen type I N-terminal propeptide (PINP) [Срок оценки: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment]
  • serum bone alkaline phosphatase (BALP) [Срок оценки: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment]
  • serum β-crosslaps (β-CTX) [Срок оценки: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment]
  • serum Ca [Срок оценки: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment]
  • serum P [Срок оценки: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment]
  • serum Mg [Срок оценки: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment]
  • serum fibroblast growth factor (FGF)23 [Срок оценки: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment]
  • serum parathormone (PTH) [Срок оценки: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment]
  • serum total 25(OH) vitamin D [Срок оценки: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment]

Критерии участия

Критерии включения

  • permanent residents
  • women aged from 45 to 79, and men aged from 50 to 79

Критерии исключения

  • severe mental diseases, physical diseases or acute infectious diseases who could not cooperate with the survey.
  • lactating or pregnant women.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 12 центров
  • Shenzhen Pingle Orthopedic Hospital — Шэньчжэнь
  • First People's Hospital of Nankang District, Ganzhou City — Ganzhou
  • Shandong Provincial Hospital of Traditional Chinese Medicine — Цзинань
  • Yunnan Provincial Hospital of Traditional Chinese Medicine — Куньмин
  • Dongzhimen Hospital, Beijing — Пекин
  • Wangjing Hospital, China Academy of Chinese Medical Sciences — Пекин
  • Affiliated Hospital of Changchun University of Traditional Chinese Medicine — Changchun
  • Guangdong Provincial Hospital of Traditional Chinese Medicine — Гуанчжоу
  • … и ещё 4 центра

Публикации

  • Wang J, Shu B, Li CG, Xie XW, Liang D, Chen BL, Lin XC, Wei X, Wang L, Leng XY, Zhou YJ, Chen PZ, Tao YR, Zhou Y, Zhang Y, Cui XJ, Lu S, Wang H, Shi Q, Wang YJ. Polymorphisms of genes related to vitamin D metabolism and transportation and its relationship with the risk of osteoporosis: protocol for a multicentre prospective cohort study in China. BMJ Open. 2019 Nov 24;9(11):e028084. doi: 10.1136/b PMID 31767578
  • Wang J, Chen L, Zhang Y, Li CG, Zhang H, Wang Q, Qi X, Qiao L, Da WW, Cui XJ, Lu S, Wang YJ, Shu B. Association between serum vitamin B6 concentration and risk of osteoporosis in the middle-aged and older people in China: a cross-sectional study. BMJ Open. 2019 Jul 4;9(7):e028129. doi: 10.1136/bmjopen-2018-028129. PMID 31278103

Идентификаторы

NCT: NCT02958020 · osteoporosis cohort

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗