Authorised Therapeutic use (Phase IV) Hypoparathyroidism

Impact of treatment with TransCon PTH on Quality of Life, cognitive function, brain structure, and cerebral capillary bloodflow in patients with hypoparathyroidism

EU CTIS ID: 2025-523930-14-00

What this study is testing

We would like to compare patients with chronic HypoPT treated with TransCon for a long-time period with chronic HypoPT patients treated with conventional treatment (activated vitamin D analogue and calcium supplements) to investigate whether the effect of HypoPT on QoL, neuropsychiatric indices, brain structures, and capillary blood flow are reversed with PTH treatment. We will apply our contrast-enhanced MRI based method to examine whether differences in brain structure and capillary dysfunction depends on the treatment used.

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Male or female with age between 18 and 80 years.
  • A low endogenous PTH production is verified by low plasma levels of intact PTH, necessitating treatment with 1-αhydroxylated vitamin D analogs.
  • Stable P-calcium levels 1 month prior to inclusion
  • Stable thyroid function as measured by thyroid stimulating hormone (TSH)
  • Speaks and reads Danish

You likely can't join if

  • Reduced kidney function (eGFR < 30 mL/min/1.73m2).
  • Claustrophobia
  • Pregnancy
  • Unwillingness to participate
  • Uncontrolled diabetes type 1 or 2
  • Uncontrolled hypertension
See the full eligibility criteria
Who can join
  • Male or female with age between 18 and 80 years.
  • A low endogenous PTH production is verified by low plasma levels of intact PTH, necessitating treatment with 1-αhydroxylated vitamin D analogs.
  • Stable P-calcium levels 1 month prior to inclusion
  • Stable thyroid function as measured by thyroid stimulating hormone (TSH)
  • Speaks and reads Danish
What rules you out
  • Reduced kidney function (eGFR < 30 mL/min/1.73m2).
  • Claustrophobia
  • Pregnancy
  • Unwillingness to participate
  • Uncontrolled diabetes type 1 or 2
  • Uncontrolled hypertension
  • Clinical suspicion of major depression (also if treated)
  • Clinical suspicion of ongoing alcohol abuse (or alcohol-related dementia)
  • Other organic or psychiatric cause the patients’ symptoms
  • Contraindications to contrast-enhanced MRI.
  • Metal implants close to the head, which will interfere with the MRI or pacemaker. The patients will complete a metal scheme

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.