RecruitingACTRN12625000514404

A Registry on comparing the older and and newer treatment methods for Hypoparathyroidism in Greece

The Greek National Registry of HypOPArathyroidism (The OPA study): Burden of Disease, Care Gaps and Treatment Efficacy DIfferences Between Older and Newer Treatments.


Sponsor

Rodis D Paparodis - Hellenic Endocrine Network

Enrollment

500 participants

Start Date

Mar 3, 2025

Study Type

Observational

Conditions

Summary

The present study aims to characterize the treatment methods, outcomes and care gaps of the treatment strategies used in Greece to treat permanent hypoparathyroidism. Registering multiple patients with this uncommon condition, we will be able to identify flaw or care gaps in the treatment and follow up of this vulnerable patient population, Furthermore, the comparison of older (conventional) treatments' effects with newer agents introduced in the last decade could reveal unknown positive or negative effects of both and help define the populations more likely to benefit from each one of these strategies.


Eligibility

Sex: Both males and femalesMin Age: 12 Yearss

Plain Language Summary

Simplified for easier understanding

Hypoparathyroidism is a rare condition where the parathyroid glands do not produce enough parathyroid hormone, causing dangerously low blood calcium levels. Most people are treated with calcium supplements and active Vitamin D (conventional therapy), but newer hormone replacement therapies have become available in the past decade. This registry study in Greece is comparing the long-term outcomes and care gaps associated with these older and newer treatment approaches. By enrolling a large group of patients with permanent hypoparathyroidism and tracking their health over time, researchers hope to identify which patients benefit most from each treatment strategy and where the current system is falling short. You may be eligible if you are 12 or older and have permanent hypoparathyroidism — defined as persistently low blood calcium (corrected for albumin below 8.5 mg/dL) for at least 12 consecutive months. This is an observational registry (no experimental treatment), and participation involves sharing data from your medical records and regular follow-up assessments. The findings could shape better treatment guidelines for a condition that affects people throughout their lives.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Prospective registry of patients affected by hypoparathyroidism of any etiology, followed at the Endocrinology, Diabetes and Metabolism clinics of the Hellenic Endocrine Network. In this study the dat

Prospective registry of patients affected by hypoparathyroidism of any etiology, followed at the Endocrinology, Diabetes and Metabolism clinics of the Hellenic Endocrine Network. In this study the data recorded will consist of clinical information regarding patients' gender, age at diagnosis of hypoparathyroidism, the disease cause, severity, treatments used in the past, the complications observed along with the recentmost treatments and their outcomes. These data will consist of all available information from the date off diagnosis of hypoparathyroidism to the date of study enrollment, with a minimum period of 18 months required for study participation. Additionally, prospective data on disease related complications, quality of life, treatment success or failure and care gaps will be collected over 5 years, including use of usual or newer agents. The main outcomes are the maintenance of eucalcemia (normal serum calcium corrected to albumin: 8.5-10.0mg/dl), the maintenance of normal urine calcium as measured by 24 hours urine collection (<300mg/dl/24hrs), the incidence of nephrolithiasis, nephrocalcinosis, ectopic calcifications, chronic kidney disease (eGFR<60ml/min/1.73m2), need for renal replacement therapy, cardiovascular disease events (myocardial infarctions, cerebrovascular events, peripheral arterial disesase events, significant vascular stenoses, need for percutaneous vascular interventions), arrhythmias (atrial fibrillation, other), congestive heart failure, osteoporosis, osteoporotic and non-osteoporotic fractures, patients' quality of life. The treatment that the patients involved in the Registry receive, will not be affected by their participation in the Registry, since this is not an interventional study. Each participating center will decide on the treatment strategy to follow in each case, based on clinical information and current national and international clinical practice guidelines.


Locations(1)

Greece

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