Teriparatide for Postsurgical Hypoparathyroidism

Plain-language guide to NCT01171690: phase 2 interventional trial of Teriparatide, post-surgical inflammation and surgery recovery, 5 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT01171690
Phase: phase 2
Status: terminated early
Start: 2010-11
Completion (planned or actual): 2013-12
Participants: 5 (actual)
Design: na, open label (everyone knows who gets what), treatment
Conditions studied: Hypoparathyroidism Post-surgical
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

In this phase 2 trial, researchers set out to test Teriparatide for post-surgical inflammation and surgery recovery.

The hypothesis was that teriparatide ( Forteo) would shorten the length of hospitalization post thyroidectomy in patients with symptomatic hypoparathyroidism.

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

The registry classes the interventions as drug.

More on the Plan

Therapy for hypocalcemia continued in accordance with current practice.

Subjects were followed by phone and with blood tests 2 days after discharge and 9, 17 and 25 days after initiation of teriparatide.

They were off teriparatide for 24 hours prior to testing on days 9, 17 and 25.

If hypocalcemia recurred after 2nd week, teriparatide was continued for a 3rd week and then discontinued.

Who Took Part

5 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Patients post bilateral thyroid bed surgery (cancer, Graves disease, multinodular goiter). Parathyroid hormone (PTH) level below low end of normal range.

The full record lists 4 inclusion and 14 exclusion criteria; among the exclusions: renal failure; any prior parathyroid pathology; pre-existing hypercalcemia.

How the Study Was Run

The set-up was single-group and open-label.

Nothing was hidden in this open-label Teriparatide study: the post-surgical inflammation and surgery recovery 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 2010-11 with completion listed for 2013-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Hospital Length of Stay (time frame: Approximately 7 days after surgery).

It also tracked 1 secondary outcome, for example Safety Analysis.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Teriparatide in 5 people with post-surgical inflammation and surgery recovery.

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

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Teriparatide compound page, Post-surgical inflammation and surgery recovery research.

Our Notes on the Compound

Teriparatide: A parathyroid hormone fragment, PTH(1-34), with human trials and approved-pen labeling; the research vial is not the approved pen.

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.