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 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

120

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Sep 2003

Geographic Reach

1 country

13 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.1 years study duration

Study Start

First participant enrolled

September 1, 2003

Completed

2 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed

7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed

12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed

Last Updated

January 26, 2007

Status Verified

January 1, 2007

First QC Date

September 12, 2005

Last Update Submit

January 24, 2007

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

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 Outcomes (1)

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.

Interventions

teriparatideDRUG

Eligibility Criteria

Age30 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (13)

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

Location

Edmonton, Alberta, Canada

Location

Vancouver, British Columbia, Canada

Location

Winnipeg, Manitoba, Canada

Location

Moncton, New Brunswick, Canada

Location

St. John's, Newfoundland and Labrador, Canada

Location

Halifax, Nova Scotia, Canada

Location

Hamilton, Ontario, Canada

Location

London, Ontario, Canada

Location

Ottawa, Ontario, Canada

Location

Toronto, Ontario, Canada

Location

Montreal, Quebec, Canada

Location

Saskatoon, Saskatchewan, Canada

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Parathyroid HormonePeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

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 DIRECTOR

Study Design

Study Type: interventional
Phase: phase 3
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

September 1, 2003

Study Completion

October 1, 2005

Last Updated

January 26, 2007

Record last verified: 2007-01

Locations

CA(13)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (13)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations