Phase 2 Dose-finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women With Osteoporosis

What Was Tested

In this phase 2 trial, researchers set out to test Teriparatide.

It had five arms (groups): Placebo (placebo comparator), one (experimental), one (experimental), one (experimental) and teriparatide (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 222 actual participants took part.

It was open to women only aged from 55 years up to 85 years.

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

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: history of bone disorders (e.g., paget's disease) other than postmenopausal osteoporosis; prior treatment with approved or as yet unapproved bone-acting investigational agents; history of carcinoma, nephrolithiasis or urolithiasis within the past five years or osteosarcoma at any time.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

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.

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 and investigator.

It started in 2007-04 with completion listed for 2009-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Marker of Bone Metabolism, PINP (time frame: 6 months). Change in Bone Mineral Density, Total Spine (time frame: 6 months).

It also tracked 3 secondary outcomes, for example Change in Bone Mineral Density, Femoral Neck, Change in Bone Mineral Density, Total Hip and Change in Bone Mineral Density, Total Spine.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Teriparatide in 222 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.