Effect of Supraphysiological rhGH on Bone Metabolism in Patients With Anorexia Nervosa
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Bone Metabolism
研究概览
简要总结
Decreased bone strength is a serious medical problem present in many women with Anorexia Nervosa, or disordered eating. Women with weaker bones are more likely to suffer broken bones than women with normal bone strength.
We are investigating whether a hormone that is naturally produced by the human body, called growth hormone, can help strengthen the bones of women with this type of disordered eating.
详细描述
- Twelve week study
- Eight visits, six of which can be conducted at your home physician's office
- Two bone density scans
- Hormonal and nutritional evaluations
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 14 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women between 14 to 45 years with anorexia nervosa
排除标准
- •pregnancy
- •previous history of malignancy.
- •oral contraceptive pills or other hormones within last 8 - 12 weeks
- •medications known to affect bone within last 12 weeks
- •fracture within last 6 months
研究组 & 干预措施
1
Treatment with rHGH
干预措施: Recombinant Human Growth Hormone (Drug)
2
Treatment with Placebo
干预措施: Placebo for Recombinant Human Growth Hormone (Drug)
结局指标
主要结局
Bone Metabolism
时间窗: Baseline, 12 weeks
Change in the marker of bone formation, N-terminal pro peptide of type 1 procollagen (P1NP) levels, between baseline and 12 weeks
次要结局
- IGF-1 Level(Baseline, 12 Weeks)
研究者
Karen Klahr Miller, MD
Chief, Neuroendocrine Unit
Massachusetts General Hospital