Assess Safety and Compare PK of New Oral hPTH(1-34) Tablet Formulations vs. EBP05 Tablets and Subcutaneous Forteo

What Was Tested

In this phase 1 trial, researchers set out to test Teriparatide for osteoporosis and bone density.

It had 19 arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

Stated in summary, eligibility criteria and outcome measures.

Who Took Part

45 actual participants took part.

It was open to men only aged from 18 years up to 35 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Healthy male subjects, 18 - 35 years of age, inclusive, at screening. Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at screening. Understands the study procedures described in the Informed Consent Form (ICF), be willing and able to comply with the protocol, and provides written consent.

The full record lists 5 inclusion and 27 exclusion criteria; among the exclusions: history or presence of alcohol or drug abuse or positive urine drug or blood alcohol results at screening; known allergies or sensitivities to components of the study medication (e.g. soy) or known hypersensitivity to pth or hpth(1-34); angina at screening, in the opinion of the pi;.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

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

In the crossover set-up each of the osteoporosis and bone density participants took both Teriparatide and the comparison in turn, acting as their own control.

Nothing was hidden in this open-label Teriparatide study: the osteoporosis and bone density participants and staff both knew the treatment.

It started in 2023-05-11 with completion listed for 2026-02-08.

It ran at 1 site in Israel.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Calculation of plasma levels of hPTH(1-34) AUC0-t for each treatment regimen (time frame: 6 hours). Calculation of plasma levels of hPTH(1-34) AUC0-inf for each treatment regimen (time frame: 6-14 hours). Calculation of plasma levels of hPTH(1-34) AUC%extrap for each treatment regimen (time frame: 6-14 hours).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Teriparatide in 45 people with osteoporosis and bone density.

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

More context: the Teriparatide compound page, Osteoporosis and bone density research.