Efficacy and safety of recombinant human parathyroid hormone (1-84) in hypoparathyroidism (REPLACE): a double-blind, placebo-controlled, randomised, phase 3 study

What Was Tested

The paper reports a study of Parathyroid Hormone (PTH 1-84), published as a randomized controlled trial.

Hypoparathyroidism results in impaired mineral homoeostasis, including hypocalcaemia and hyperphosphataemia.

Who Took Part

By PubMed's age tags, the people studied were teenagers, young adults, adults, middle-aged adults, older adults and people over 80, both men and women.

In this double-blind, placebo-controlled, randomised phase 3 study (REPLACE), the researchers recruited patients with hypoparathyroidism (≥ 18 months duration) aged 18-85 years from 33 sites in eight countries.

How the Study Was Run

The design is described as randomized, double-blind and placebo-controlled.

The participants were allocated by chance, so the Parathyroid Hormone (PTH 1-84) group and the comparison group should start out alike.

Neither the participants nor the staff measuring them knew who was on Parathyroid Hormone (PTH 1-84), so expectations could not easily colour the readings.

The comparison arm used a placebo, so changes seen with Parathyroid Hormone (PTH 1-84) could be set against what happens without it.

This trial is registered with ClinicalTrials.gov, number NCT00732615.

What Was Measured

Topics PubMed links to this paper include Calcium Citrate, Headache, Hypoparathyroidism, Parathyroid Hormone, Recombinant Proteins, Spasm and Vitamin D.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Parathyroid Hormone (PTH 1-84).

Its findings take up roughly 5 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2013 (The lancet. Diabetes & endocrinology), a journal based in England.

More context: the Parathyroid Hormone (PTH 1-84) compound page, all human trials.