QoL and Cognitive Function in Patients With Hypoparathyroidism (NCT04569604) | Clinical Trial Compass
CompletedNot Applicable
QoL and Cognitive Function in Patients With Hypoparathyroidism
Denmark64 participantsStarted 2019-10-01
Plain-language summary
Hypoparathyroidism (HypoPT) is a disease with inadequate production of parathyroid hormone (PTH) from the parathyroid glands leading to hypocalcemia. The most common form is postsurgical HypoPT due to neck surgery resulting in removed or damaged parathyroid glands.
HypoPT is a complex disease with a reduced Quality of life, mild cognitive impairment and in some patients have brain calcifications.
The aim of the present study is to investigate the cognitive function in patients with postsurgical and non-surgical (HypoPT) by neuropsychological assessments and magnetic resonance imaging (MRI).
The investigators will apply a contrast-enhanced MRI based method to HypoPT patients and age- and gender matched controls to examine whether capillary dysfunction can be detected, and whether symptom severity across patients correlates with the degree of capillary dysfunction in certain brain regions. To our knowledge there have been no previous studies on cognitive impairment and its origin in patients with HypoPT. The investigators hypothesize that the symptoms of HypoPT patients represent various degrees of capillary dysfunction, which interfere with their brain function.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients:
* Male or female with age between 18 and 70 years.
* A low endogenous PTH production as verified by low plasma levels of intact PTH, necessitating treatment with 1-αhydroxylated vitamin D analogs.
* HypoPT for 3 years with continuous alphacalcidol or calcitriol treatment prior to study entry (except for the patients with PHP).
* Stable P-calcium levels 1 month prior to inclusion.
* In case of thyroid disease, TSH within reference range within the last year
* Speaks and reads Danish
Controls:
* Male or female with age between 18 and 80 years.
* No known diseases in the calcium homeostasis
* Speaks and reads Danish
Exclusion Criteria:
* Reduced kidney function (eGFR \< 30 mL/min/1.73m2).
* Diabetes type 1 or 2
* History of hypertension for more than two years (treated or untreated)
* Clinical suspicion of major depression (also if treated)
* Clinical suspicion of 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.
* Claustrophobia
* Unwillingness to participate
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Capillary transit time heterogeneity
Timeframe: MRI scan performed at baseline, no follow-up up. It takes 1 hour to perform