Investigating long-term effects of post-surgical hypoparathyroidism
Cardiovascular, Renal, and Skeletal Complications in Patients With Post-Surgical Hypoparathyroidism
This study is trying to see if people who have low parathyroid hormone levels after surgery face more heart, kidney, and bone problems compared to healthy individuals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 1 site (Aarhus N) |
| Trial ID | NCT06419270 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the long-term cardiovascular, renal, and skeletal complications in patients diagnosed with post-surgical hypoparathyroidism. It will compare these patients to age and gender-matched healthy controls to evaluate arterial stiffness, coronary artery plaque burden, and prevalence of vertebral fractures. Participants will undergo various assessments including CT scans, DXA scans, tonometry, blood sampling, and 24-hour urine collection. The study seeks to clarify the health risks associated with chronic hypoparathyroidism following surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with chronic post-surgical hypoparathyroidism diagnosed for more than five years and requiring treatment with active vitamin D.
Not a fit: Patients with acute renal failure, active cancer, or those who have undergone neck surgery are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term health risks faced by patients with post-surgical hypoparathyroidism, potentially leading to improved management strategies.
How similar studies have performed: While there is existing research on chronic hypoparathyroidism, this specific observational approach to post-surgical cases is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Aarhus N
- Department of Endocrinology and Internal Medicine — Aarhus N, Denmark (Recruiting)
Study contacts
- Principal investigator: Lars Rejnmark — Aarhus University Hospital
- Study coordinator: Sarah Thornhoj
- Email: sarthorn@rm.dk
- Phone: 4540491821
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.