CONTROLLED TRIAL USING INTRAVENOUS CGP-42446 IN PAGET'S DISEASE OF BONE

使用静脉注射 CGP-42446 治疗佩吉特骨病的对照试验

• 批准号: 5215607
• 负责人: KENNETH W. LYLES
• 金额: --
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/5215607
• 关键词: alkaline phosphatase; clinical chemistry; clinical research; diphosphonate; dosage; drug screening /evaluation; human subject; human therapy evaluation; hydroxyproline; osteitis deformans; skeletal disorder chemotherapy; skeletal pharmacology

Paget's disease of bone is a chronic progressive skeletal disorder of unknown etiology caused by an increase in bone remodeling (osteoclastic resorption and osteoblastic formation) leading to bone pain and skeletal deformities. In this Phase II Trial, a new bisphosphonate, CGP-42446, will be used in patients with Paget's disease of bone. The purpose of this study is to determine the safety and tolerability of a new bisphosphonate in the treatment of Paget's disease of bone. Intravenous administration of CGP-42446 in increasing doses of 50, 100, 200, and 400 mcg will be used. The effect on serum alkaline phosphatase and urinary hydroyxproline levels will be compared to those measurements in patients receiving placebo. This is a multi-centered double blind parallel group, randomized, placebo controlled trial. This study is completed and is a international multicenter trial and we were responsible for recruiting seven patients to receive varying doses of placebo and/or CGP-42446. We have enrolled and treated seven patients in the trial. The results are being analyzed by the industry sponsor.

Paget的骨骼是一种慢性进行性骨骼疾病 骨骼重塑的增加引起的未知病因（破骨碎屑 吸收和成骨细胞形成）导致骨痛和骨骼 畸形。 在此II期试验中，新的双膦酸盐CGP-42446， 将用于Paget骨骼疾病的患者。 目的 这项研究是为了确定新的安全性和耐受性 双膦酸盐治疗Paget骨骼疾病。 静脉 施用CGP-42446，增加了50、100、200和400的剂量 将使用MCG。 对血清碱性磷酸酶和尿液的影响 将Hydroyxproline水平与患者的测量值进行比较 接受安慰剂。 这是一个以上为中心的双盲平行组， 随机，安慰剂对照试验。 这项研究完成了，是 国际多中心试验，我们负责招募 七名患者接受不同剂量的安慰剂和/或CGP-42446。 我们 在试验中已入学并治疗了7名患者。 结果是 由行业赞助商分析。