Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34

What Was Tested

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

It had two arms (groups): PTH 1-34 (experimental) and Calcitriol & Calcium (experimental).

The registry classes the interventions as drug.

More on the Plan

This side effect usually occurs even while maintaining the serum calcium in the normal range and may lead to calcium deposition in the kidney (nephrocalcinosis) and renal insufficiency.

This study examines the long-term effects of subcutaneous parathyroid hormone (PTH) therapy on calcium metabolism, bone, and renal function.

Patients initially come to the Clinical Center for a two week inpatient evaluation.

Subsequent follow-up will occur semiannually on an outpatient basis.

Who Took Part

The registry lists 27 actual participants took part.

It was open to people of any sex aged from 17 years up to 69 years.

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

The full record lists 1 inclusion and 0 exclusion criteria.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Parathyroid Hormone (PTH 1-84) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 1991-10 with completion listed for 2014-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Serum Calcium Level (time frame: 3 years). Urine Calcium Excretion Level (time frame: 3 years).

It also tracked 5 secondary outcomes, for example Serum 1,25-hydroxyvitamin D Level, Serum 25-hydroxyvitamin D Level, Serum Magnesium Level, Serum Phosphorus Level and Urinary Creatinine Clearance.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Parathyroid Hormone (PTH 1-84) in 27 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.