Study of Teriparatide (FORTEO) to Treat Adults With Osteogenesis Imperfecta

What Was Tested

The trial (phase 4) is built around Teriparatide.

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

Daily SQ placebo for 18 months.

The registry classes the interventions as drug.

More on the Plan

OI affects approximately 1-2 of every 10,000 individuals.

Virtually all of the studies of potential treatments for OI have evaluated the effects of medications only on children with OI.

There are very limited data concerning the usefulness of parathyroid hormone therapy in OI.

Adult patients (age at least 18 yrs) with OI will be enrolled for a treatment duration of 18 months.

Who Took Part

79 actual participants took part.

It was open to people of any sex aged from 18 years up to 85 years.

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

Examples of who could join: \> 2 previous adult fractures, AND/OR. BMD at lumbar spine, femoral neck or total hip T score \< -2.0.

The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: open epiphyses; history of external beam radiation to the skeleton; pagets disease.

How the Study Was Run

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

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.

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 2005-06 with completion listed for 2011-01.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Spine Bone Mineral Density (BMD) (time frame: baseline and 18 months).

It also tracked 1 secondary outcome, for example Total Hip BMD.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Teriparatide in 79 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.