Cardiovascular, Renal, and Skeletal Complications in Patients With Post-Surgical Hypoparathyroidism (NCT06419270) | Clinical Trial Compass
CompletedNot Applicable
Cardiovascular, Renal, and Skeletal Complications in Patients With Post-Surgical Hypoparathyroidism
Denmark100 participantsStarted 2024-05-26
Plain-language summary
The aim of this observational study is to learn about long term effects to post surgical hypoparathyroidism. The main questions are:
1. Patients with hypoparathyroidism do not have an increased arterial stiffness compared to healthy controls.
2. Patients with hypoparathyroidism do not have an increased coronary artery plaque burden assessed by cardiac CT compared to healthy controls.
3. Patients with hypoparathyroidism do not have an increased prevalence of vertebral fractures compared to healthy controls.
Results will be compared with gender and age matched controls from the general population.
Participants will have a CT scan, DXA scan, tonometry, blood samples and questionaries performed and collect a 24-hour urine sample.
Who can participate
Age range
18 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 only:
* Chronic post surgical hypoparathyroidism diagnosed \> 5 years ago. (In case recruitment is too challenging, we will accept duration of disease of minimum one year. Including patients with longest duration of disease first.)
* Require treatment with active vitamin D ≥ 1 µg/day
Controls only:
* No history of neck surgery
* No history of parathyroid disease
All participants:
* Age ≥ 18 years
* 25(OH)D vitamin ≥ 50 nmol/L
* Serum magnesium ≥ 0,50 mmol/L
* Able to read and understand Danish
* Willing and able to sign the informed consent form
Exclusion Criteria:
* Estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73 m3
* Active cancer or former (except thyroid and basal cell skin) cancer treatment \< 5 year ago
* Pregnancy, or breastfeeding \< 1 year ago
* Untreated thyroid or liver diseases during the last year
* Treatment with lithium within the last 4 weeks
* Known allergy or sensitivity to iodine
* Any reason that in the opinion of the investigator, that would prevent the patient from completing the study.
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.