Study to Assess the Blood Concentrations and Actions of Recombinant Human Parathyroid Hormone (rhPTH [1-84]) When Given Once and Twice Daily to Participants With Hypoparathyroidism

What Was Tested

The trial (phase 1) is built around Parathyroid Hormone (PTH 1-84).

It had four arms (groups): A/B or B/A (experimental), C/B or B/C (experimental), D/E or E/D (experimental) and F/E or E/F (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 34 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

The full record lists 13 inclusion and 4 exclusion criteria; among the exclusions: known history of hypoparathyroidism resulting from an activation mutation in the calcium sensing receptor (casr) gene or impaired responsiveness to pth (pseudohypoparathyroidism).

How the Study Was Run

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

Because people in this Parathyroid Hormone (PTH 1-84) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Parathyroid Hormone (PTH 1-84) and the comparison at some point, usually with a gap in between.

Being open-label, the Parathyroid Hormone (PTH 1-84) study did not mask who received what.

It started in 2017-04-03 with completion listed for 2019-03-08.

It ran at 15 sites in United States (10), Hungary (3), Canada (1) and Denmark (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Maximum Plasma Concentration (Cmax) of Baseline Adjusted rhPTH(1-84). Area Under the Curve Extrapolated to Infinity (AUCinf) of Baseline Adjusted rhPTH(1-84). Terminal Half-Life (t1/2) of Baseline Adjusted rhPTH(1-84).

It also tracked 1 secondary outcome, for example Number of Participants With Treatment Emergent Adverse Events (TEAE's).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Parathyroid Hormone (PTH 1-84) in 34 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Parathyroid Hormone (PTH 1-84) compound page, all human trials.