Recombinant Human rhPTH(1-34) VS Association Alfacalcidol/Hydrochlorothiazide in Severe Primary Hypoparathyroidism

What Was Tested

The trial (phase 2) is built around Teriparatide.

Hypoparathyroidism is a rare condition in which the parathyroid glands fail to produce sufficient amount of parathyroid hormone or the parathyroid hormone produced lacks biologic activity.

The most common cause of hypoparathyroidism is damage to or removal of the parathyroid glands due to neck surgery for another condition.

Occurrence of hypercalciuria under treatment is a frequent concern in primary hypoparathyroidism, limiting correction of hypocalcemia.

It had two arms (groups): rh PTH(1-34) (experimental) and Thiazide + potassium sparing diuretic (active comparator).

The registry classes the interventions as drug.

More on the Plan

The design consists in a five-periods, two-treatments, open-label, randomized, crossover study with blind end-point evaluation.

Patients will ambulatory monitor serum calcium, sodium, potassium, and creatinine levels at days 15 of run in and run out periods and at day 7 and day 28 of each treatment period.

Who Took Part

16 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 aged from 18 to 80 years, of both sexes. Patient with primary hypoparathyroidism related to a genetically proven ADH OR primary hypoparathyroidism related to other cause but complicated by hypercalciuria under treatment.

The full record lists 3 inclusion and 24 exclusion criteria; among the exclusions: pregnant and breastfeeding women;; women of childbearing age without contraception;; for men aged from 18 to 20 years, presence of cartilage of growth on x-ray of left knee;.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Teriparatide and who got the comparison, which limits bias.

Each person switched between Teriparatide and the comparison at some point, usually with a gap in between.

Everyone knew when Teriparatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2017-06-06 with completion listed for 2020-05-28.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Plasma calcium concentration (time frame: two months of treatment).

It also tracked 25 secondary outcomes, for example Ambulatory calcium concentration, Calciuria, Plasma calcium x phosphate product, Blood pressure, Serum sodium level and Serum potassium level.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Teriparatide in 16 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Teriparatide compound page, all human trials.