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Pump delivery of hormone may steady calcium levels in rare disorder

NCT ID NCT00743782

Disease control Sponsor: National Institutes of Health Clinical Center (CC) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested two ways of delivering synthetic parathyroid hormone (PTH) to people with chronic hypoparathyroidism, a condition where the body doesn't make enough PTH, causing low calcium. Researchers compared using an insulin pump to give steady, small doses versus twice-daily injections. The goal was to see if the pump could keep blood and urine calcium levels more stable, mimicking natural hormone release. The trial included 21 adults and children with different forms of the disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
synthetic human parathyroid hormone (PTH 1-34)
What this could lead to
If successful, this could offer a more convenient and effective way to manage hypoparathyroidism, reducing daily fluctuations in calcium levels.
What could go wrong
This is a small, early-phase study with only 21 participants, so results may not apply to everyone. The pump method may not work better or could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

21 people

The number who actually took part.

Started

Aug 2008

Finished

Apr 2014

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

7 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* INCLUSION CRITERIA: This study will include up to 24 patients of both genders (ages 7-70) with biochemically confirmed chronic hypoparathyroidism of at least one year duration. We will recruit adults with post-surgical hypoparathyroidism and children with genetic forms of hypoparathyroidism including autoimmune polyendocrine syndrome type 1 (APS-1) or hypocalcemia due to an activating mutation of the calcium sensing receptor. EXCLUSION CRITERIA: Subjects who meet any of the following criteria are not eligible for study entry: * Presence of significant hepatic or kidney disease * Pregnancy * Patients who are calcium infusion dependent. * Seizure disorder requiring antiepileptic medications

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Conditions

The condition(s) this trial relates to.

autoimmune polyendocrine syndrome type 1 autosomal dominant hypocalcemia autosomal dominant hypocalcemia 1 Hypocalcemia hypoparathyroidism Polyendocrinopathies, Autoimmune

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autoimmune polyendocrine syndrome type 1 Autosomal dominant hypocalcemia type 1 (ADH1) Hypocalcemia Hypoparathyroidism

Contacts and locations

Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892, United States

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