Recruiting

Observational Study

Sponsor:

Columbia University

Code:

NCT05793853

Conditions

Hypoparathyroidism

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Study Details

Brief summary:

This is a prospective three-year natural history study of adults with hypoparathyroidism. The goal is to monitor patients with hypoparathyroidism to define end-organ damage in the context of the disease.

The study objectives are to:

1. Build a prospective cohort of patients to study HPT-associated end-organ damage.
2. Determine end-organ physiologic consequences of HPT.
3. Elucidate determinants of HPT-associated end-organ damage.

Funding Source - FDA OOPD

Conditions

Hypoparathyroidism

Study ID

NCT05793853

Start date

Aug 25, 2022

Status verified date

Dec, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

106 participants

Anticipated

Interventions and Outcome Measures

Arms

Hypoparathyroidism Subjects

Patients who have the disease hypoparathyroidism, who are being followed to monitor various aspects of the disease over time. No interventions.

Control Subjects

Healthy individuals to be followed to compare to hypoparathyroidism patients

Primary outcome measure

  • Kidney function [ Time Frame: baseline, 6, 12, 18, 24, 30, 36 Months ]

Central Contacts and Locations

Central contacts

Noelle Texeira

212-305-2801ngt2115@cumc.columbia.edu

Aastha Mehta

212-342-0132am5724@cumc.columbia.edu

Locations

Columbia University Medical Center - Harkness Pavillion

Recruiting

New York, New York, United States, 10032

Contacts

Noelle Texeira

212-305-2801ngt2115@cumc.columbia.edu

Principal Investigator:

Mishaela Rubin, MD

More Information

Sponsor

Columbia University

Last update posted

Dec 16, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2025-12-16.