Effect of Long-acting PTH Analogues on Markers of Subclinical Arterial and Myocardial Injury in Chronic Hypoparathyroidism..
Effect of Long-acting PTH Analogues on Markers of Subclinical Arterial and Myocardial Injury in Chronic Hypoparathyroidism..
The goal of this study is to evaluate cardiovascular effects of long-acting parathyroid hormone (PTH) analogues in adults with chronic hypoparathyroidism. The main questions it aims to answer are:
In the prospective part, patients that just started long-acting PTH analogue therapy based on their treating physicians choice will be followed for 12 months, with repeat assessments at baseline, 3 months, and 12 months to evaluate changes in cardiovascular markers.
The goal of this study is to better understand how chronic hypoparathyroidism affects heart and blood vessel health, and whether treatment with a long-acting parathyroid hormone (PTH) analogue can improve cardiovascular function. Hypoparathyroidism is a rare condition in which the body does not produce enough PTH, leading to low calcium levels and possible long-term complications, including an increased risk of cardiovascular disease.
This study aims to answer the following main questions:
Do people with chronic hypoparathyroidism have early (subclinical) signs of damage to the heart and blood vessels compared to people without the condition? Does treatment with a long-acting PTH analogue improve vascular health and reduce early markers of cardiovascular disease over time?
The study includes two parts. In the first part, researchers will compare adults with hypoparathyroidism-either receiving standard treatment (calcium and vitamin D) or long-acting PTH therapy-with healthy individuals of similar age and health characteristics. Participants that will undergo the non-invasive tests to assess blood vessel stiffness, blood pressure, microcirculation, and heart function, along with blood tests to measure calcium balance and cardiovascular biomarkers, as part of routine clinical practice will be eligible for the study.
In the second part, participants with hypoparathyroidism who are starting treatment with a long-acting PTH analogue will be followed for 12 months. They will be evaluated at the beginning of the study, at 3 months and again at 12 months. Researchers will track changes in blood vessel function, heart performance, and biochemical markers to determine whether restoring normal PTH levels improves cardiovascular health.
All participants will undergo detailed clinical assessments, including imaging of blood vessels and the heart, as well as laboratory testing. The findings from this study may help improve understanding of cardiovascular risk in hypoparathyroidism and guide future treatment strategies.
Inclusion Criteria:
- Cross sectional arm: Baseline State: Adults (≥18y) with chronic HypoPT (≥12 months) currently treated with conventional therapy or palopegteriparatide for more than one year
-Prospective Follow-up: Adults (≥18y) with chronic HypoPT (≥12 months) currently treated with conventional therapy and about to start treatment with palopegteriparatide willing to undergo baseline measurements (prior to the first dose) and repeat measurements at 3 and 12 months.
Exclusion Criteria:
Renal Function: CKD Stage 3 or higher (eGFR < 60 mL/min/1.73 m²)
Uncontrolled Risk Factors:
Bone Health: Any metabolic bone disease other than hypoparathyroidism (excluding osteoporosis)
Documented Atrial Fibrillation (ECG)
Contraindication to long acting PTH analogue as per product labeling