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Compliance and Acceptance of Teriparatide Injection in Severely Osteoporotic Patients

NCT00191802 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2007-01-26

No results posted yet for this 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.

Conditions

Interventions

DRUG

teriparatide

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9am - 5pm Eastern Time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Completion
2005-10-31

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00191802 on ClinicalTrials.gov