drugset / Trial / NCT00191802

Compliance and Acceptance of Teriparatide Injection in Severely Osteoporotic Patients

NCT00191802

Phase 3 Completed 120 enrolled Eli Lilly and Company
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purposes of this study are to evaluate the acceptance of the subcutaneous drug teriparatide over 6 months of therapy in patients with severe osteoporosis in Canada, and to evaluate how often such patients are actually able to use the injection; to obtain additional safety data (side effect data) that will supplement the existing database of adverse events that have been reported to-date in clinical trials by patients treated with teriparatide; to document the prior use of other osteoporosis therapies in this patient population, and ongoing use of other osteoporosis therapies during the study; and to describe the baseline demographics and disease state of these severely osteoporotic patients.The purposes of the study extension are to continue to assess the acceptance of the subcutaneous drug teriparatide over up to 18 months of therapy in patients with severe osteoporosis in Canada, and to continue to assess how often such patients are actually able to use the injection; to obtain additional safety data (side effects) that will supplement the existing database of adverse events that have been reported to date in clinical trials by patients treated with teriparatide.

Timeline

Start
2003-09
Primary completion
Completion
2005-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Teriparatide Protein / enzyme biologic Subcutaneous

Indications