A CLINICAL TRIAL OF (1-34)HPHT IN ESTROGEN TREATED OSTEOPOROTIC PATIENTS
A CLINICAL TRIAL OF (1-34)HPHT IN ESTROGEN TREATED OSTEOPOROTIC PATIENTS
批准号:
2336127
负责人:
金额:
$0.0万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
--
资助国家:
美国
项目状态:
未结题
起止时间:
至
中文摘要
此申请代表了对临床持续资助的请求
英文摘要
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.
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