NCT01556360已完成不适用
Bone Status on Patients With Genetic Hemochromatosis : a 3 Years Descriptive and Evolutionary Study.
Rennes University Hospital12 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2008年7月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 12
- 主要终点
- Bone mineral density
研究概览
简要总结
The purpose of this study is to describe bone status on patients with genetic hemochromatosis, at diagnostic time and his evolution under treatment.
详细描述
Bone diseases have been recognized recently as complications of genetic hemochromatosis. Further studies are needed to describe the role of iron in bone injuries. The purpose of this study is to describe bone status on patients with genetical hemochromatosis, at diagnostic time and his evolution under treatment.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18 and 80 years
- •C282 homozygosity
排除标准
- •corticosteroids during the last 3 months
- •following treatments during the last 6 months : anabolic steroids, growth hormone, hormone therapy for menopause, tibolone, raloxifene.
- •following treatments during inclusion or in the last 6 month : teriparatide, parathormone, fluor, strontium ranelate, biphosphonate.
- •cancer or evolutionary hemopathy (including monoclonal gammopathy)
- •pregnancy at inclusion time
- •treated osteoporosis
- •patient in wich follow up seems hard
- •inclusion in another study incompatible with this one
结局指标
主要结局
Bone mineral density
时间窗: Change from baseline in bone mineral density at three years
Vertebral and hips Dual energy X-ray Absorptiometry (DXA)
次要结局
- Number of peripheral fractures(3 years)
- Number and location of joint lesions detected by the examination (pain and swelling)(3 years)
- Predictive value of iron overload on Bone Mineral Density(1 day)
- Number of vertebral fractures(3 years)
- Determination of genetic polymorphism of BMP 2 and 4(Baseline)
研究者
研究点 (12)
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