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临床试验/NCT01677637
NCT01677637已完成不适用

Epidemiological, Observational, Multicenter Clinical Trial

Elpen Pharmaceutical Co. Inc.1 个研究点 分布在 1 个国家目标入组 5,500 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
5,500
试验地点
1
主要终点
Osteoporosis Indicator

研究概览

简要总结

Osteoporosis is the most common disease of bone and characterized firstly by low bone mass and secondly, impaired bone microarchitecture structure resulting in reduced strength and increased risk of fracture. Osteoporosis is divided into: primary (Postmenopausal Osteoporosis Osteoporosis & elderly and senile osteoporosis) and secondary. The most common form is postmenopausal osteoporosis. It occurs in women after menopause and is associated with decreased estrogen production, which normally occurs at this age women Osteoporosis usually occurs after age 50, it is very common in women than in men, and its frequency increases with advancing age.

详细描述

According to the findings of epidemiological studies in different countries, osteoporosis affects 25-35% of women and 15-20% of men aged 50 and over. In terms of our country in the recent nation-epidemiological research on rheumatic diseases in the general adult population, ie persons aged 19 and over, organized and conducted by the Greek Institute of Rheumatology Research, became a separate study on frequency of osteoporosis in women aged 50 years and above. These women was measured BMD at the lumbar spine and at the upper end of the femur and found that 28.4% of Greek women aged 50 and over have osteoporosis. It is indeed very interesting finding in this study that women who have osteoporosis, the vast majority, ie about 75%, I do not know. This is of particular importance and highlights the need to educate and inform systematically the public, especially women regarding both the modern possibilities for early diagnosis of osteoporosis, and for the implementation of primary and secondary prevention.

Osteoporosis is a major public health problem for two reasons: First, because it is common, and secondly because it has significant impact on patients and their families, the health system and the national economy.

The main clinical manifestation of osteoporosis is fractures low energy, ie fractures occurring after mild degree injury, eg fall from a standing position. Approximately 40% of cases osteoporotic fractures on the vertebrae, 20% in the femoral neck, 20% to 20% radius and several other bones. While osteoporosis is generally regarded as a disease of women, however, as already mentioned above, osteoporosis affects and men. It has even been found that 30% of osteoporotic fractures of the femoral neck and 20% of osteoporotic vertebral fractures occur in men.

The risk of fractures of the hip, vertebrae and radius increases with advancing age in both women and men. It has even been estimated that the risk of osteoporotic fracture in women aged 50 and over is 40-50% and 15-20% in men.

The adverse effects of osteoporosis patients and their families, the health system and the national economy due to fractures. Indicative only some of these effects:

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
30 Years 至 90 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Postmenopausal women
  • Outpatients screened for osteoporosis
  • Women > 45 years
  • Women < 45 years under menopause
  • Women obtained their consent to be measured

排除标准

  • Premenopausal females
  • Women without any symptom of menopause
  • Women not obtained their consent to be measured

结局指标

主要结局

Osteoporosis Indicator

时间窗: 1 year

T-score per female as measured by Holofic Sahara Instrument

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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