Comparison of the Effects of 2 Drugs on Lumbar Spine Volumetric BMD in Men With Glucocorticoid-Induced Osteoporosis

What Was Tested

The trial (phase 3) is built around Teriparatide.

It had two arms (groups): Teriparatide (experimental) and Risedronate (active comparator).

The registry classes the interventions as drug.

More on the Plan

This study is a multinational, European, multicenter, randomized, open-label, active comparator controlled study with 2 study periods: a screening phase of up to 6 weeks, and an open-label treatment phase of 18 months.

Who Took Part

Enrollment: 92 actual participants took part.

It was open to men only aged from 25 years with no upper age limit.

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

Examples of who could join: A minimum of 2 lumbar vertebrae (L) in the L-1 through L-3 region must be evaluable by quantitative computerized tomography.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: abnormal albumin-corrected serum calcium levels; history of unresolved skeletal diseases that affect bone metabolism other than glucocorticoid-induced osteoporosis; abnormal thyroid function not corrected by therapy.

How the Study Was Run

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

Because people in this Teriparatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

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

It started in 2007-07 with completion listed for 2010-10.

It ran at 13 sites in Germany (7), Greece (2), Italy (2) and Spain (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Tomography (QCT) at 18 Months (time frame: Baseline, 18 months).

It also tracked 8 secondary outcomes, for example Change From Baseline in Areal Bone Mineral Density (BMD) at Lumbar Spine, Femoral Neck, and Total Hip at 18 Months, Change From Baseline in Serum Aminoterminal Propeptide of Type I Procollagen (P1NP) at 3 Months, 6 Months, and 18 Months, Change From Baseline in Serum Type I Collagen Degradation Fragments (β-CTx) at 3 Months, 6 Months, and 18 Months and Number of Participants With Adverse Events (AEs).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Teriparatide in 92 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.