Pharmacokinetic and PHarmacodynamic Analysis and Evaluation of Teriparatide (PTH 1-34) Between Sexes

What Was Tested

The trial (phase 3) is built around Teriparatide.

It had 1 arm (groups): Treatment (experimental).

The registry classes the interventions as drug.

More on the Plan

Gedeon Richter and Thornton and Ross presented data in osteoporotic patients to the MHRA to license their products as biosimilars.

Teriparatide has also been investigated in the treatment of stress fractures, but there are no published data comparing the PKs and PDs of these drugs in a population equivalent to individuals undergoing military training (i.e. young healthy men and women).

Existing data to support the equivalence of teriparatide between sexes is limited.

Citrate and calcium infusions have been used to characterise the impact of sex differences on PTH dynamics in twelve women with mean age ± SD of 26.4 ± 1.6 years and 12 men with mean age of 26.6 ± 1.3 years.

Who Took Part

30 actual participants took part.

It was open to people of any sex aged from 18 years up to 36 years.

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

Examples of who could join: Have provided written informed consent to participate;. Be able to comply with protocol;. Be able to adequately understand written and spoken English;. Be aged between 18 and 36 years;. Have a BMI ≥18.5 and ≤28.0 kg/m2;.

The full record lists 9 inclusion and 13 exclusion criteria; among the exclusions: hypersensitivity to the active pth or any of the excipients listed in any of the smpcs; pre-existing hypercalcaemia; participants with skeletal malignancies or bone metastases.

How the Study Was Run

It was run as a single-group and open-label study.

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 2021-05-24 with completion listed for 2021-07-05.

It ran at 1 site in United Kingdom.

Its stated primary purpose is other.

What Was Measured

Primary outcome: Concentration over time assessed by the area under the curve (AUC) of teriparatide (PTH (1-34)). The maximum concentration (Cmax) for teriparatide (PTH 1-34).

It also tracked 5 secondary outcomes, for example The reproducibility of Concentration over time assessed by the area under the curve (AUC) of teriparatide (PTH (1-34)).

What This Means in Plain Language

Put simply, this is a phase 3 trial of Teriparatide in 30 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.