Compliance and Acceptance of Teriparatide Injection in Severely Osteoporotic Patients

Osteoporosis Clinical Trial

Official title:

Compliance With and Acceptance of Teriparatide Pen Injection in Severely Osteoporotic Patients [CATS]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00191802
• Other study ID #: 8370
• Secondary ID: B3D-CA-GHCP
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: January 24, 2007
• Start date: September 2003
• Est. completion date: October 2005

Study information

• Verified date: January 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• teriparatide

Locations

Country	Name	City	State
Canada	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	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	Edmonton	Alberta
Canada	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	Halifax	Nova Scotia
Canada	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	Hamilton	Ontario
Canada	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	London	Ontario
Canada	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	Moncton	New Brunswick
Canada	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	Montreal	Quebec
Canada	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	Ottawa	Ontario
Canada	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	Saskatoon	Saskatchewan
Canada	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	St. John's	Newfoundland and Labrador
Canada	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	Toronto	Ontario
Canada	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	Vancouver	British Columbia
Canada	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	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective is to determine the acceptance of, and compliance with, 6 months of teriparatide subcutaneous injections in patients with severe osteoporosis who have failed on OR are intolerant to currently available osteoporosis therapies.
Secondary	To obtain safety data; to document the prior use of other osteoporosis therapies, and concomitant use of other osteoporosis therapies; to describe the baseline demographics and disease state of these severely osteoporotic patients.