RecruitingRare disease

Study on Indapamide for Patients with Chronic Post-Surgical Hypoparathyroidism

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Indapamide in patients who have a condition known as chronic post-surgical hypoparathyroidism. This condition occurs when the parathyroid glands, which help regulate calcium levels in the body, are underactive following surgery. The trial will compare the effects of Indapamide to a placebo, which is a substance with no active medication, to see how it affects calcium levels in the urine.

The purpose of the study is to investigate how daily treatment with Indapamide for 14 days influences the amount of calcium excreted in the urine of patients with this condition. Participants will be randomly assigned to receive either Indapamide or a placebo. The study will last for a total of 14 days, during which changes in urinary calcium excretion will be monitored at both 7 and 14 days. Additionally, the study will observe changes in blood calcium levels and the need for supplements like active vitamin D and oral calcium.

Throughout the study, participants will follow a sodium-restricted diet to see how it affects calcium levels during the placebo period. The trial aims to provide valuable insights into the management of chronic post-surgical hypoparathyroidism and the potential benefits of using Indapamide as a treatment option. The findings could help improve the quality of life for individuals living with this condition by better managing their calcium levels.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of chronic post-surgical hypoparathyroidism made over a year ago, ensuring age is 18 years or older, and confirming the need for active vitamin D treatment of at least 1 microgram per day.
Blood tests are performed to check ionized plasma calcium levels between 1.15-1.25 mmol/L, 25(OH)D vitamin levels of at least 50 nmol/L, and plasma magnesium levels greater than 0.65 mmol/L.
Step 2
Informed consent
Participants must be able to read and understand Danish and are required to sign an informed consent form, indicating their willingness to participate in the study.
Step 3
Treatment phase
The treatment phase involves daily administration of Indapamide or placebo tablets taken orally for a duration of 14 days.
The primary objective is to observe changes in 24-hour urinary calcium excretion after 7 and 14 days of treatment.
Step 4
Monitoring and evaluation
Throughout the treatment phase, regular monitoring is conducted to assess changes in plasma ionized calcium levels and any adjustments in supplementation with active vitamin D and oral calcium.
Participants may also follow a sodium restrictive diet during the placebo period to evaluate its impact on urinary calcium excretion and plasma ionized calcium levels.
Step 5
Completion of trial
The trial concludes after 14 days of treatment, with final assessments to measure the primary and secondary endpoints.
The estimated end date for the trial is December 1, 2026.

Who can join the trial?

8 criteria

Have been diagnosed with **chronic post-surgical hypoparathyroidism** for more than 1 year. This means you have low levels of parathyroid hormone after surgery.
Be **18 years or older**.
Need to take **active vitamin D** at a dose of 1 microgram or more each day. Active vitamin D helps your body use calcium.
Have **ionized plasma calcium** levels between 1.15 and 1.25 mmol/L. This is a measure of the calcium in your blood that is not attached to proteins.
Have **25(OH)D vitamin** levels of 50 nmol/L or higher. This is a form of vitamin D in your blood.
Have **plasma magnesium** levels greater than 0.65 mmol/L. Magnesium is a mineral important for many body functions.
Be able to **read and understand Danish**.
Be willing and able to **sign the informed consent form**. This means you agree to participate in the study after understanding what it involves.

Who cannot join the trial?

4 criteria

Patients who do not have chronic post-surgical hypoparathyroidism cannot participate. This condition occurs when the parathyroid glands, which help control calcium levels in the body, are underactive after surgery.
Patients who are not within the specified age range cannot participate. The study includes adults and older adults.
Both male and female patients are eligible, so gender is not a reason for exclusion.
Patients who are part of a vulnerable population, such as those unable to give consent, are not included in this study.

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Verified sites

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Verified
Aarhus University Hospital
Aarhus, Denmark

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Investigated drugs

Indapamide is a medication used in this trial to help manage calcium levels in patients who have low parathyroid hormone levels after surgery. It is being tested to see if it can reduce the amount of calcium lost in urine, which is a common issue in people with this condition.

INDAPAMIDE HEMIHYDRATE

What is already known about the treatment

Indapamide – Indapamide is administered orally in tablet form. It is currently being studied in clinical trials for its effects on urinary calcium excretion in patients with chronic post-surgical hypoparathyroidism. The main therapeutic indication for Indapamide in this context is to manage calcium levels in the body. At the molecular level, Indapamide works by inhibiting sodium reabsorption in the kidneys, which helps to reduce calcium excretion in urine. It is classified as a thiazide-like diuretic, commonly used to treat high blood pressure and fluid retention.

Investigated diseases

Hypoparathyroidism – This condition occurs when the parathyroid glands do not produce enough parathyroid hormone, which is crucial for maintaining a balance of calcium and phosphorus in the body. As a result, individuals may experience low levels of calcium in the blood and high levels of phosphorus. Symptoms can include muscle cramps, tingling in the fingers, and fatigue. Over time, if untreated, it can lead to more severe symptoms such as muscle spasms or even seizures. The condition is often chronic, especially if it results from surgical removal or damage to the parathyroid glands. Management typically focuses on maintaining normal calcium and phosphorus levels in the body.