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Compliance and Acceptance of Teriparatide Injection in Severely Osteoporotic Patients

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clinicaltrials.gov/study/NCT00191802
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT001918020
Health Conditions in Trial
Osteoporosis
Osteoporosis
0
Trial Recruitment Size
1200
Trial Sponsor
Eli Lilly
Eli Lilly
0
Clinical Trial Start Date
2003
0
Study Completion Date
2005
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Interventional Trial Phase
Phase 30
Official Name
Compliance With and Acceptance of Teriparatide Pen Injection in Severely Osteoporotic Patients [CATS]0
Last Updated
January 26, 2007
0
Allocation Type
Non-Randomized0
Intervention Model
Single Group Assignment0
Masking Type
None (Open Label)0
Study 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.

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