ADD-ON Study to Existing Hypoparathyroidism Studies

Plain-language guide to NCT00856401: phase 3 interventional trial of Parathyroid Hormone (PTH 1-84), 62 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00856401
Phase: phase 3
Status: status unknown
Start: 2010-09
Completion (planned or actual): 2020-12-31
Participants: 62 (actual)
Design: na, open label (everyone knows who gets what), diagnostic
Conditions studied: Hypoparathyroidism
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

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

The purpose of this protocol is to add on additional exploratory studies to investigate changes in bone quality parameters with PTH(1-84) treatment of hypoparathyroidism.

How these abnormalities may be corrected with PTH(1-84) administration are not fully understood.

It had 1 arm (groups): PTH1-84 in parent study (experimental).

In the RELAY, RACE, and HEXT study participants utilize PTH1-84. In the REPLACE Study participants utilize PTH1-84 or placebo of PTH1-84.

The registry classes the interventions as drug.

More on the Plan

The parent NPS trial, being conducted under NPS's IND #76,514, is a multi-site, randomized, double-blind, placebo-controlled trial of PTH(1-84) in hypoparathyroidism.

The Columbia site is one of the investigative sites for the NPS protocol.

A letter from NPS accompanying this document certifies that Dr.

Bilezikian is a subinvestigator in the NPS project.

Who Took Part

The registry lists 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.

Examples of who could join: Active participation in the HEXT Study of Dr. John Bilezikian.

The full record lists 2 inclusion and 0 exclusion criteria.

How the Study Was Run

The set-up was 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 2010-09 with completion listed for 2020-12-31.

It ran at 1 site in United States.

Its stated primary purpose is diagnostic.

What Was Measured

The main thing measured (primary outcome): HRpQCT (time frame: before and after treatment). sclerostin (time frame: variable depending on parent study). circulating osteogenic precursors (time frame: variable depending on parent study).

What This Means in Plain Language

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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.