Comparing Pump With Subcutaneous Injection Delivery of PTH 1-34 in the Management of Chronic Hypoparathyroidism

What Was Tested

This registered phase 2 trial tested Parathyroid Hormone (PTH 1-84).

It had two arms (groups): PTH 1-34 delivered through pump, then subcutaneous injection (active comparator) and PTH 1-34 subcutaneous injection, then delivered through pump (active comparator).

The registry classes the interventions as drug.

More on the Plan

The researchers are conducting a randomized crossover study comparing PTH delivered by an insulin pump vs twice-daily subcutaneous injections.

The researchers hypothesize that pump delivery of PTH 1-34, compared to injections, will provide smoother metabolic control of serum mineral levels with minimal fluctuations, normalization of urine mineral excretion and markers of bone turnover.

The two arms will be divided into an inpatient and an outpatient phase.

There will be three inpatient admissions at baseline, 3 months and 6 months which are separated by two 3-month outpatient periods.

Who Took Part

The registry lists 21 actual participants took part.

It was open to people of any sex aged from 7 years up to 70 years.

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

The full record lists 1 inclusion and 4 exclusion criteria; among the exclusions: patients who are calcium infusion dependent; seizure disorder requiring antiepileptic medications.

How the Study Was Run

The set-up was randomized, crossover and open-label.

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 2008-08-22 with completion listed for 2014-04-07.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mean Serum Calcium in Adults. Mean Urine Calcium Excretion in Adults.

It also tracked 29 secondary outcomes, for example Mean Serum Phosphorus in Adults, Mean Urine Phosphorus Excretion in Adults, Mean Serum Magnesium in Adults, Mean Urine Magnesium Excretion in Adults, Mean Serum Alkaline Phosphatase in Adults and Mean Serum 1,25-hydroxyvitamin D3 in Adults.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Parathyroid Hormone (PTH 1-84) in 21 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.