Not yet recruitingRare disease

Study evaluating the effects of palopegteriparatide and alfacalcidol on quality of life and brain function in patients with 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 study focuses on individuals living with hypoparathyroidism, a rare condition where the parathyroid glands do not produce enough parathyroid hormone. This lack of hormone can affect how the body manages minerals like calcium. The purpose of the study is to compare the effects of a new treatment with the standard way the condition is managed.

Participants will be assigned to receive either palopegteriparatide, also known as TransCon PTH, through a subcutaneous injection, which is a small needle under the skin, or the standard treatment. The standard treatment consists of alfacalcidol, an active form of vitamin D, and calcium supplements taken orally. This study aims to observe how these different treatments affect daily life, thinking skills, and blood flow within the small vessels of the brain.

During the study, various assessments will be performed to monitor changes. This includes the use of MRI, a medical imaging technique that creates detailed pictures of the inside of the body, to look at the structure of the brain. The research also examines how blood moves through the capillaries, which are the tiny blood vessels that connect larger arteries and veins, to see if the treatment helps improve brain health and overall well-being.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
<b>medication administration</b>
One of two treatment paths is assigned. the first path involves taking alfacalcidol, which is an activated vitamin D analogue used to manage hypoparathyroidism (a condition where the parathyroid glands do not produce enough hormone). this is taken as 10 micrograms in a soft capsule by mouth.
The second path involves receiving palopegteriparatide. this is an injection administered under the skin using a pre-filled pen. the dose is 420 micrograms.
Step 2
<b>medical assessments</b>
The cognitive function, which refers to mental processes such as memory and thinking, is measured through neuropsychological assessments.
An mri, which is a type of medical imaging used to see inside the body, is performed to examine brain structures and capillary blood flow. this includes checking the microvascular hemodynamic, which refers to how blood moves through the smallest blood vessels in the brain.

Who can join the trial?

8 criteria

You can be either a male or a female.
You must be between the ages of 18 and 80 years.
You must have hypoparathyroidism, which is a condition where your body does not produce enough parathyroid hormone (PTH), a hormone that helps regulate calcium levels in your blood.
It must be confirmed through blood tests that your intact PTH (the active form of the hormone) is low.
Because of your condition, you must currently be using 1-alpha-hydroxylated vitamin D analogs, which are specific types of vitamin D medicine used to manage calcium.
Your plasma calcium levels, which is the amount of calcium found in the liquid part of your blood, must have remained stable for at least one month before joining the study.
Your thyroid function, which refers to how well your thyroid gland works, must be stable as measured by a test called TSH (thyroid stimulating hormone).
You must be able to speak and read Danish.

Who cannot join the trial?

11 criteria

Having reduced kidney function, which means the kidneys are not filtering waste from the blood as well as they should (measured by a value called eGFR).
Having claustrophobia, which is an intense fear of being in small or enclosed spaces.
Being pregnant.
A decision to not take part in the study.
Having uncontrolled diabetes, which is a condition where blood sugar levels are too high and not being managed effectively.
Having uncontrolled hypertension, which is high blood pressure that is not being kept within a healthy range.
A suspected case of major depression, which is a mental health condition that causes persistent feelings of sadness or loss of interest.
A suspected case of ongoing alcohol abuse or memory problems caused by alcohol, known as alcohol-related dementia.
Having other physical or mental health conditions that explain your symptoms.
Any medical reason that prevents you from having a contrast-enhanced MRI, which is a specialized brain scan that uses a special dye to show details more clearly.
Having metal implants near your head that could interfere with the scan or having a pacemaker, which is a small device placed in the chest to help control the heartbeat.

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Verified
Aarhus University Hospital
Aarhus, Denmark

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Investigated drugs

Palopegteriparatide
is a medication given as an injection under the skin. It is being tested to see if it can help manage hypoparathyroidism by acting as a replacement for the parathyroid hormone that the body is not producing enough of on its own.
Alfacalcidol
is a type of activated vitamin D that is taken by mouth in capsule form. It is used as a standard comparison treatment to help manage calcium levels in people with hypoparathyroidism.

What is already known about the treatment

Alfacalcidol
This medication is taken as a soft capsule by mouth to help manage low calcium levels. It is a well-established treatment used widely in medicine to supplement vitamin D. The drug works by converting into the active form of vitamin D within the body, which then helps the intestines absorb calcium more effectively. It is classified as an activated vitamin D analogue.
Palopegteriparatide
This medicine is administered as an injection under the skin using a pre-filled pen. It is currently being studied as a specialized treatment for rare conditions like hypoparathyroidism. At a molecular level, it works by mimicking the natural parathyroid hormone to help regulate calcium and phosphorus levels in the blood. This substance is classified as a long-acting parathyroid hormone analogue.

Investigated diseases

Hypoparathyroidism - This condition occurs when the parathyroid glands do not produce enough parathyroid hormone. This hormone is essential for maintaining the correct levels of calcium in the blood. As the condition progresses, calcium levels in the bloodstream drop too low, while phosphorus levels may rise. This imbalance can affect how nerves and muscles function throughout the body. Over time, the lack of sufficient hormone can lead to various changes in bodily processes.