Compliance and Acceptance of Teriparatide Injection in Severely Osteoporotic Patients

What Was Tested

This registered phase 3 trial tested Teriparatide.

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.

The registry classes the interventions as drug.

Who Took Part

The registry lists 120 planned participants were the target.

It was open to people of any sex aged from 30 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. There should be no other medical causes of the osteoporosis (called idiopathic osteoporosis) except for low estrogen (in women) or low testosterone (in men). Must be able to understand and sign an approved informed consent document.

The full record lists 8 inclusion and 5 exclusion criteria; among the exclusions: 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; recent or currently active kidney stone, or major problems with kidney function.

How the Study Was Run

The set-up was non-randomized, single-group and open-label.

Nothing was hidden in this open-label Teriparatide study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2003-09 with completion listed for 2005-10.

It ran at 13 sites in Canada (13).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: 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.

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Teriparatide in 120 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Teriparatide compound page, all human trials.