Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of PTH Analog Tablets in Postmenopausal Women

What Was Tested

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

It had three arms (groups): PTH analog tablet (experimental), Placebo (placebo comparator) and Forsteo (active comparator).

Placebo matching tablet, once daily.

The registry classes the interventions as drug.

Who Took Part

97 actual participants took part.

It was open to women only aged from 45 years up to 80 years.

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

Examples of who could join: Healthy postmenopausal women (45-80 years old) with a diagnosis of osteoporosis.

The full record lists 1 inclusion and 6 exclusion criteria; among the exclusions: use of estrogen or hormone replacement therapy; use of bisphosphonates, strontium ranelate or denosumab; use of parathyroid analogues or other bone metabolic agents.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Teriparatide and who got the comparison, which limits bias.

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, investigator and outcomes assessor.

It started in 2011-02 with completion listed for 2011-10.

It ran at 4 sites in Denmark (3) and Estonia (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): % Change From Baseline BMD in L1-L4 Axial Lumbar Spine at Week 24 (time frame: 24 weeks from baseline).

It also tracked 3 secondary outcomes, for example % Change From Baseline in Bone Resorption Marker (CTx-1) at Week 24, Systemic Absorption of PTH at Week 24 and % Change From Baseline in Bone Formation Marker (P1NP) at Week 24.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Teriparatide in 97 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.