Compliance and Acceptance of Teriparatide Injection in Severely Osteoporotic Patients

Status:

COMPLETED

Compliance and Acceptance of Teriparatide Injection in Severely Osteoporotic Patients

Lead Sponsor:

Eli Lilly and Company

Conditions:

Osteoporosis

Eligibility:

All Genders

30+ years

Phase:

PHASE3

Brief 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 ...

Eligibility Criteria

Inclusion

Postmenopausal woman OR a man at least 30 years of age (who no longer have bone growth)
In the opinion of the investigator:
The patient must have severe osteoporosis (defined as a low bone mass AND a fracture related to osteoporosis), and be at high risk for fracture despite currently available therapies
Patients should have failed or been shown to be intolerant to currently commercially available osteoporosis therapies. (Failure of therapy: fracture, or significant loss of bone mass)
There should be no other medical causes of the osteoporosis (called idiopathic osteoporosis) except for low estrogen (in women) or low testosterone (in men)
In the opinion of the investigator, the patient can learn to use the pen type injection delivery system and will be able to use it either alone or with appropriate assistance
Must be able to understand and sign an approved informed consent document
Must be able to come in for follow-up visits for the duration of the study.

Exclusion

High blood calcium levels, high parathyroid hormone levels in the blood, high levels of a blood test called alkaline phosphatase that haven't been explained yet.
Known or suspected bone diseases other than osteoporosis
Any medical condition that might increase a patient's baseline risk for bone tumors (including prior radiation to the skeleton, Paget's disease, previous bone tumors).
Recent or currently active kidney stone, OR major problems with kidney function
Serious ongoing medical problems incompatible with the study (as assessed by the investigator)

Key Trial Info

Start Date :

September 1 2003

Trial Type :

INTERVENTIONAL

End Date :

October 1 2005

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT00191802

Start Date

September 1 2003

End Date

October 1 2005

Last Update

January 26 2007

Active Locations (13)

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Page 1 of 4 (13 locations)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Calgary, Alberta, Canada

Edmonton, Alberta, Canada

Vancouver, British Columbia, Canada

Winnipeg, Manitoba, Canada

Trial Details

Trial ID

NCT00191802

Start Date

September 1 2003

End Date

October 1 2005

Last Update

January 26 2007

Status: