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临床试验/NCT02142348
NCT02142348Unknown不适用

Longitudinal Study of Primary Osteoporosis in Shanghai Postmenopausal Women

Shanghai University of Traditional Chinese Medicine1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
3,000
试验地点
1
主要终点
Bone Mineral Density

研究概览

简要总结

To popularize knowledge of prevention and health care of osteoporosis.To investigate the prevalence of primary osteoporosis in community residents.

详细描述

  1. Objective:
  • To popularize knowledge of prevention and health care of osteoporosis.
  • To investigate the prevalence of primary osteoporosis in community residents.
  1. Method:
  • The survey study included the five boroughs of six communities in Shanghai (Xuhui District 2, Pudong New Area 1, Minhang District 1, Pudong New Area 1, Jiading District 1). 10,000 participants are expected to be included.
  • Through a questionnaire and physical examination form, carries on the investigation to the 50-85 years old postmenopausal women during the 3-year follow-up period.
  • Make a survey of Bone Mineral Density,SF-36,international osteoporosis foundation ONE-MINUTE OSTEOPOROSIS RISK TEST,Markers of bone metabolism test,EQ-5D,Hepatic-renal function test and thyroid stimulating hormone level test.
  • Physicians in each community as the backbone, Shanghai University of Traditional Chinese Medicine, Longhua Hospital is responsible for personnel training.
  • Shanghai Clinical Research Center is responsible for program and data management.
  • Shanghai District Health and Family Planning Commission is responsible for coordinating the organization.

研究设计

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

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Had clinical diagnosis of osteoporosis.
  • With Bone Mineral Density by dual energy X-ray examination, T value <-2.5 or less.
  • Be willing to and be able to join in the study and signed Informed consent.

排除标准

  • Excluding the impact of endocrine diseases of bone metabolism (gonadal, adrenal, parathyroid and thyroid disease), rheumatoid arthritis and other autoimmune diseases that affect the absorption of calcium and vitamin D and regulation of the digestive tract and kidney disease, multiple myeloma and other malignant diseases, long-term use of corticosteroids or other drugs affecting bone metabolism, and a variety of congenital and acquired diseases of bone metabolism.
  • if they were unable to complete the study survey.

结局指标

主要结局

Bone Mineral Density

时间窗: baseline

次要结局

  • international osteoporosis foundation ONE-MINUTE OSTEOPOROSIS RISK TEST(baseline)
  • Hepatic-renal function test(baseline)
  • SF-36(baseline)
  • Markers of bone metabolism test(baseline)
  • thyroid stimulating hormone level test(baseline)
  • EQ-5D(baseline)

研究者

发起方
Shanghai University of Traditional Chinese Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cui xuejun

Vice director

Shanghai University of Traditional Chinese Medicine

研究点 (1)

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