Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis

What Was Tested

The trial (phase 3) is built around Teriparatide.

Glucocorticoids (such as prednisone) are prescribed to treat a large number of conditions such as arthritis and asthma.

When taken for several months or longer, glucocorticoids can cause bone loss and lead to a form of osteoporosis called "glucocorticoid-induced osteoporosis." This study compared the effects of teriparatide, the study drug, with alendronate, an approved drug for treating glucocorticoid-induced osteoporosis.

It had two arms (groups): A (experimental) and B (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 428 actual participants took part.

It was open to people of any sex aged from 21 years with no upper age limit.

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

Examples of who could join: Men or women age 21 years or older.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got Teriparatide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Teriparatide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2002-11 with completion listed for 2006-07.

It ran at 15 sites in United States (6), Belgium (3), Austria (2), Puerto Rico (2), Denmark (1) and Norway (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD) (time frame: 18 month endpoint).

It also tracked 14 secondary outcomes, for example Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset, Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined, Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset, Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined, Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined and Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Teriparatide in 428 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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