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Search / Trial NCT05793853

Hypoparathyroidism Natural History

Launched by COLUMBIA UNIVERSITY · Mar 20, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial, called the Hypoparathyroidism Natural History study, aims to understand how hypoparathyroidism affects adults over three years. Hypoparathyroidism is a condition where the body does not produce enough parathyroid hormone, leading to low calcium levels. By monitoring patients, the researchers hope to identify any damage that might occur to different organs as a result of this condition.

To participate, individuals must be at least 18 years old and have a confirmed diagnosis of hypoparathyroidism, which means they have low calcium levels and low parathyroid hormone levels on two separate occasions. Both men and women are welcome to join, and they can be receiving any type of treatment, including calcium and vitamin D supplements. Participants will need to provide written consent to join the study and must be willing to follow the study's procedures. This research could help improve understanding and management of hypoparathyroidism, benefiting future patients.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • An understanding, ability and willingness to fully comply with study procedures and restrictions.
  • Ability to voluntarily provide written, signed and dated informed consent as applicable to participate in the study.
  • Male or female ≥18 years of age with HPT. All HPT sub-types are eligible, including surgical (HPT-S) and nonsurgical (HPT-NS) HPT: autoimmune, genetic (including but not limited to: DiGeorge syndrome, autoimmune polyendocrine syndrome type 1, hypoparathyroidism sensorineural deafness and renal disease syndrome, Kearns-Sayre syndrome, mitochondrial encephalomyopathy with lactic acidosis and stroke-like episodes \[MELAS\] syndrome, mitochondrial trifunctional protein \[MTP\] deficiency syndrome, Kenny-Caffey syndrome, Sanjad-Sakati syndrome, autosomal dominant hypocalcemia), infiltrative (granulomatous), mineral deposition (copper, iron), metastatic, radiation and idiopathic HPT.
  • Diagnosis of HPT established based on historic hypocalcemia in the setting of inappropriately low serum PTH levels on two occasions.
  • All treatment regimens are permitted, including but not limited to conventional management with calcium (e.g. calcium citrate, calcium carbonate, etc), active vitamin D (calcitriol, alfacalcidol), parent vitamin D, magnesium, phosphate binders and thiazides. Use of PTH-like drugs are permitted.
  • Exclusion Criteria:
  • Functional HPT
  • Transient HPT
  • Pseudohypoparathyroidism
  • Pregnancy

About Columbia University

Columbia University, a prestigious Ivy League institution located in New York City, is a leading sponsor of clinical trials dedicated to advancing medical research and improving patient care. With a robust network of research facilities and a commitment to innovation, Columbia University collaborates with a diverse range of healthcare professionals and researchers to explore groundbreaking therapies and treatment methodologies. The university's clinical trials encompass various fields, including oncology, neurology, and public health, aiming to translate scientific discoveries into effective clinical applications. Columbia University is dedicated to maintaining the highest ethical standards and regulatory compliance, ensuring the safety and well-being of trial participants while contributing to the global body of medical knowledge.

Locations

New York, New York, United States

Patients applied

0 patients applied

Trial Officials

Mishaela Rubin, MD

Principal Investigator

Columbia University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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