drugset / Trial / NCT01430104

A Study of Teriparatide in Japanese Osteoporosis Patients

NCT01430104

Phase 4 Completed 30 enrolled Eli Lilly and Company
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this trial is to assess the effects on serum calcium when teriparatide is used with active vitamin D in osteoporosis patients. This study consists of a Screening Period, a 14-day Lead-in Period, a 28-day Treatment Period, and a 7-day Follow-up Period. Patients will take vitamin D and calcium supplementation from the Lead-in Period throughout the study. During the Treatment Period, daily administration of teriparatide will be added.

Timeline

Start
2011-08
Primary completion
2011-12
Completion
2011-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Teriparatide Protein / enzyme biologic 20 ug Subcutaneous
Background Alfacalcidol Other / unclassified 1 ug Oral
Background Aspara-CA Unknown 600 mg Oral

Indications