NCT00347737撤回不适用
The Effects of Therapy With Teriparatide (Recombinant Parathyroid Hormone (1-34) on Vascular Compliance and Osteoprotegerin/RANKL
Leland Graves III, MD1 个研究点 分布在 1 个国家开始时间: 2006年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- The study measures changes in vascular compliance with teriparatide 1 hour, 3 months, and 6 months after initiating teriparatide. Osteoprotegerin and RANKL levels
研究概览
简要总结
The purpose of this study is to determine what effect teriparatide will have on vascular (blood vessel) compliance and osteoprotegerin (bone fluid)and RANKL levels (bone cells).
详细描述
Research subjects participation is about 6 months. Subjects will give themselves daily injections of teriparatide after instruction on technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women and men over the age of 40 who are starting therapy with teriparatide
排除标准
- •Patients with diabetes mellitus
- •current smokers
- •patients with a history of organ transplantation
- •Patients currently of previously on glucocorticoid therapy within the past year
- •Patients with serum creatinine above 1.5 mg/dl, patients with uncontrolled hypertension (BP 140/90 or greater)
- •Patients ineligible for teriparatide therapy: History of metabolic bone disease other than osteoporosis
- •History of radiation therapy
- •Patients pregnant or nursing
- •History of bone metastasis or skeletal malignancies
- •History of hypercalcemia
研究组 & 干预措施
1
Experimental
Teriparatide
干预措施: teriparatide (Drug)
结局指标
主要结局
The study measures changes in vascular compliance with teriparatide 1 hour, 3 months, and 6 months after initiating teriparatide. Osteoprotegerin and RANKL levels
时间窗: baseline, 3, and 6 months
次要结局
- CRP levels(Baseline and at 6 months of therapy)
研究者
Leland Graves III, MD
Associate Professor and Division Director
University of Kansas Medical Center
研究点 (1)
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