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

Plain-language summary

This study compares the drug Teriparatide (rhPTH 1-34) with an Alfacalcidol/hydrochlorothiazide treatment in patients with severe primary hypoparathyroidism. It enrolled adults aged 18-80 with genetically proven or other-cause primary hypoparathyroidism. It was conducted in Phase 2 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

Assistance Publique - Hôpitaux de Paris

Intervention

Teriparatide, Thiazide, Potassium sparing diuretic, Alfacalcidol

Start date

6/6/2017

Estimated completion

5/28/2020

Countries

France

Related genes

Locations

• Paris, France

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion criteria :

* 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
* Affiliated to a French health insurance system, and who have consented to the study.

Exclusion criteria :

* 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;
* Anuria;
* Kidney failure with plasmatic creatinine \>125 mmol/l and urea \>10 mmol/l;
* Long QT interval : QTc \> 450 ms (men) or 470 ms (women);
* Hepatic failure;
* Metabolic bone diseases (Paget's disease of bone) other than primary osteoporosis or glucocorticoid-induced osteoporosis;
* Association to other potassium sparing diuretics;
* Hypokalemia (\<3.5 mmol/l) without diuretic therapy;
* Hyperkalemia (\>5.5 mmol/l);
* Hyponatremia (\<135 mmol/l) without diuretic therapy;
* Hypercalcemia (\>2.6 mmol/l);
* Severe hypomagnesemia (≤ 0.5 mmol/l);
* Vitamin D deficiency (25OH vit D \< 20 ng/mL);
* Unexplained increase in alkaline phosphatase (\>2N);
* Intolerance to sulfamide;
* Intolerance to amiloride or other component of the drug;
* Hypersensitivity to any active substance or excipient of one of the experimental drugs;
* Gluten intolerance;
* Bone break history within the three previous months;
* History of radiotherapy of the skeleton;
* History of bone cancer or metastasis.
* Personnal or familial (first degree relatives) of skin cancer