HEXT (Hypo EXTended): Effect of PTH on Skeleton in Hypoparathyroidism

Plain-language guide to NCT01199614: phase 3 interventional trial of Parathyroid Hormone (PTH 1-84), 62 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT01199614
Phase: phase 3
Status: completed
Start: 2009-12
Completion (planned or actual): 2017-06-26
Participants: 62 (actual)
Design: na, open label (everyone knows who gets what), treatment
Conditions studied: Hypoparathyroidism
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

The trial (phase 3) is built around Parathyroid Hormone (PTH 1-84).

This is an open-label study of PTH(1-84) treatment that seeks: 1.

To determine the actions of PTH(1-84) to provide long term control of serum calcium and urinary calcium excretion with use of standard amounts of calcium and vitamin D supplementation. 2.

It had 1 arm (groups): open-label PTH(1-84) (experimental).

The registry classes the interventions as drug.

More on the Plan

It is the only remaining hormone deficiency state for which replacement with the missing hormone has been heretofore unavailable.

The hypoparathyroid state is due either to autoimmune destruction of the parathyroid glands or to loss of parathyroid function after neck surgery.

PTH(1-84) is the ideal therapeutic approach to hypoparathyroidism.

The current mainstay of therapy, calcium and vitamin D, has important clinical limitations.

Who Took Part

62 actual participants took part.

It was open to people of any sex aged from 18 years up to 85 years.

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

The full record lists 2 inclusion and 32 exclusion criteria; among the exclusions: failure to have completed either of the inclusionary studies; signed and dated informed consent form (icf) before any study-related procedures are performed; adult males or females 18 to 85 years of age.

How the Study Was Run

Design: single-group and open-label.

Nothing was hidden in this open-label Parathyroid Hormone (PTH 1-84) study: the participants and staff both knew the treatment.

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

It started in 2009-12 with completion listed for 2017-06-26.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example Percent Change in BMD by DXA.

What This Means in Plain Language

Put simply, this is a phase 3 trial of Parathyroid Hormone (PTH 1-84) in 62 people.

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.

Our Notes on the Compound

Parathyroid Hormone (PTH 1-84): The 84-amino-acid hormone that raises blood calcium; full-length PTH (Natpara) has been used in hypoparathyroidism. Teriparatide is its 1-34 fragment.

Parathyroid Hormone (PTH 1-84) in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.