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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00145886
Other study ID # 12901A
Secondary ID
Status Terminated
Phase Phase 1
First received September 1, 2005
Last updated January 8, 2016
Start date February 2003
Est. completion date September 2011

Study information

Verified date January 2016
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine how treatment with a new medication, recombinant human parathyroid hormone (rhPTH) affects calcium balance and bone strength.


Description:

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Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
rhPTH
Subjects will be treated with rhPTH for 12 months.

Locations

Country Name City State
United States University of Chicago Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To describe the acute effects of rhPTH administration on calcium balance. The effects on calcium balance will be examined at the beginning, after 3 months, and after 12 months of treatment with rhPTH. The rational for examining calcium balance at these three time points is that (at least in patients wit osteoporosis treated with PTH) the initial response is primarily an increase in bone formation; at 3 months there is also a proportionate increase in bone resorption; and at 12 months there is an established general increase in bone turnover. The effects on calcium balance will be examined at the beginning, after 3 months, and after 12 months of treatment with rhPTH. No
Secondary To examine the effect of 12 months of therapy with rhPTH on bone density, bone turnover and bone micro-architecture. Bone density will be measured at 0, 3, 6, and 12 months in the lumbar spine, proximal femur, and distal radius using Lunar Prodigy, and in the calcaneus using Lunar PIXI (both from GE Medical Systems, Madison, Wisconsin). Bone density will be measured at 0, 3, 6, and 12 months No
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