Teriparatide (Forsteo) Treatment in Postmenopausal Women: Mechanism of Action

What Was Tested

In this phase 4 trial, researchers set out to test Teriparatide.

More recently medications that build up new bone, i.e. anabolic treatments, have been, and are being, developed.

The registry classes the interventions as drug.

Who Took Part

The registry lists 19 actual participants took part.

It was open to women only aged up to 84 years.

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

Examples of who could join: Have a bone mineral density T-score (at the lumbar spine or total hip) of less than or equal to -2.5. Be at least 5 years post menopausal (more than 5 years since their last menstrual period) but \<85 years old. Be able and willing to participate in the study and provide written informed consent.

The full record lists 6 inclusion and 30 exclusion criteria; among the exclusions: A body mass index less than 18 or greater than 35; any history of cancer within the past 5 years excluding skin cancer non melanomas; acute or chronic hepatic disease.

How the Study Was Run

The set-up was non-randomized, single-group and open-label.

Everyone knew when Teriparatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2011-01 with completion listed for 2015-08.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Volumetric bone mineral density (BMD) of the lumbar spine (mg hydroxyapatite/cm3) (time frame: 0 to 104 weeks).

It also tracked 3 secondary outcomes, for example Lumbar spine, total hip and whole body bone mineral density (g/cm2), Biochemical markers of bone turnover and Distal tibia and radius volumetric body bone mineral density (BMD) (mg hydroxyapatite/cm3).

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Teriparatide in 19 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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