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
- Objective:
- To popularize knowledge of prevention and health care of osteoporosis.
- To investigate the prevalence of primary osteoporosis in community residents.
- 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
- 否
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
Cui xuejun
Vice director
Shanghai University of Traditional Chinese Medicine
研究点 (1)
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