Phase 3 Clinical Trial of Teriparatide in Japan

What Was Tested

In this phase 3 trial, researchers set out to test Teriparatide.

It had two arms (groups): Teriparatide (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 207 actual participants took part.

It was open to people of any sex aged from 55 years with no upper age limit.

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

Examples of who could join: Japanese patients diagnosed with osteoporosis. Aged 55 or older. Patients who are at high risk for fracture.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: history of metabolic bone disorders other than primary osteoporosis; severe or chronically disabling conditions other than osteoporosis.

How the Study Was Run

Design: randomized, parallel-group and quadruple-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.

The Teriparatide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Teriparatide.

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

It started in 2007-01 with completion listed for 2008-09.

It ran at 16 sites in Japan (16).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) (time frame: Baseline to 52 weeks).

It also tracked 19 secondary outcomes, for example Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4), Percent Change in Bone Mineral Density (BMD) at Total Hip, Percent Change in Bone Mineral Density (BMD) at Femoral Neck, Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP), Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) and Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Teriparatide in 207 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.