Bone Marker Changes With Teriparatide/Postmenopausal Osteoporosis

What Was Tested

In this phase 4 trial, researchers set out to test Teriparatide for osteoporosis and bone density.

It had 1 arm (groups): A (experimental).

Teriparatide.

The registry classes the interventions as drug.

Who Took Part

The registry lists 45 actual participants took part.

It was open to people of any sex aged from 50 years with no upper age limit.

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

Examples of who could join: Presents with severe osteoporosis based on the disease diagnostic criteria and upon physician assessment. Outpatients without concomitant diseases and with life expectancy of at least 3 years, according to the medical criteria. Cannot be on medicines that can disturb bone metabolism. Patients should be capable of self-injection, to learn the use of Pen device and are in agreement with its use.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: previously completed or withdrawn from this study or any other study investigating teriparatide; secondary osteoporosis or any disease that affects the bone metabolism, as renal osteodystrophy, osteomalacia, hypoparathyroidism, and hyperparathyroidism, and intestinal malabsorption.

How the Study Was Run

Design: randomized, single-group and open-label.

The osteoporosis and bone density participants were allocated by chance, so the Teriparatide group and the comparison group should start out alike.

Nothing was hidden in this open-label Teriparatide study: the osteoporosis and bone density 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 2003-04 with completion listed for 2004-04.

It ran at 7 sites in Puerto Rico (7).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 2 secondary outcomes, for example To test the hypothesis that this group of patients will have a high score in the survey used by IOF as an instrument to check risk factors and Test the hypothesis that patients will have a high score in the survey used by IOF as an instrument to check risk factors.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Teriparatide in 45 people with osteoporosis and bone density.

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

More context: the Teriparatide compound page, Osteoporosis and bone density research.