A CLINICAL TRIAL OF (1-34)HPHT IN ESTROGEN TREATED OSTEOPOROTIC PATIENTS

该申请代表了一个临床持续资助的请求， 在我们SCOR项目的前5年开发和启动的试验。 本研究目前作为相互依赖的R 0 -1（DK-42892）获得资助。 后 为我们的SCOR竞争性更新提供资金，我们打算终止R 01。 我们认为，项目之间的相互关系及其对 彼此都证明了这种做法的合理性。 此外，临床试验将 需要支持SCOR的核心的大力支持。 因此 似乎自然包括这项研究，从而进行了更多的成本 有效的时尚，作为我们的SCOR更新应用程序的一部分。 在我们最初申请的项目5中，我们提出了一系列研究， 以确定是否可以在已建立的患者中改变骨丢失， 骨质疏松症，根据我们的研究计划已经收集的数据， 组，或在其他SCOR项目中生成的数据。 我们 主要目标是开发一种治疗患者的新方法 I型骨质疏松症 治疗方案的广义概念 当时，我们提出的建议是基于我们的观察，即短期内 给予磷酸盐（PO 4）可能通过以下途径激活骨重建： 造成继发性甲状旁腺功能亢进 在最初的研究中， PTH/维生素D系统对磷酸盐和（1-34）hPTH的反应 局 根据收集的数据，很明显， 使用PO 4作为骨骼重塑的间接刺激， 有效 在我们最初的申请中，我们宣布我们打算使用（1- 34)HPTH可用作治疗剂时。 自（1- 34)1989年，Rhone Poulenc Rounge向我们提供了HPTH，我们追求 评价（1-34）hPTH使用的预期替代策略 直接在治疗方案类似于我们原来的SCOR，但 消除了PO 4的使用。

This application represents a request for continued funding of a clinical trial developed and initiated during the first 5 years of our SCOR program. This study is currently funded as an interdependent R0-1 (DK-42892). Upon funding of our SCOR competitive renewal, we intend to terminate the R01. We feel that the inter-relationships of the projects and their reliance on each other justifies this approach. In addition, the clinical trial will require significant support from the Cores supporting the SCOR. Thus it seems natural to include this study, conducted thereby in a more cost effective fashion, as part of our SCOR renewal application. In Project 5 of our original application, we proposed a series of studies to determine if bone loss can be modified in patients with established osteoporosis, basing our research plans on data already gathered by our group, or data that were to be generated in the other SCOR projects. Our major goal was to develop a novel approach to the treatment of patients with Type I osteoporosis. The broad concepts of the treatment protocol proposed were, at that time, based on our observations that short term administration of phosphate (PO4) might activate bone remodeling by creating a secondary hyperparathyroidism. In initial studies we compared the response of the PTH/vitamin D system to phosphate and to (1-34)hPTH administration. As a result of the data collected, it became evident that using PO4 as an indirect stimulus to skeletal remodeling would be less than effective. In our original application we declared our intent to use (1- 34)HPTH when it became available for use as a therapeutic agent. Since (1- 34)HPTH was made available to us by Rhone Poulenc Rorer in 1989, we pursued the intended alternative strategy to evaluate the use of (1-34)hPTH directly in a treatment protocol similar to that in our original SCOR, but eliminating the use of PO4.