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Hypoparathyroidism Natural History Study
Advancing Product Development for Hypoparathyroidism: A Prospective Natural History Study of the Clinical Outcomes and Regulation of Disordered Mineral Metabolism
Who can join
Ages 18 to 100 · All sexes · Healthy volunteers welcome
Full 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 the study
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
Sponsor: Columbia University · Participants: 106 · Started: Aug 25, 2022
Contact the study team
- Noelle Texeira · Phone: 212-305-2801
- Aastha Mehta · Phone: 212-342-0132
Official record on ClinicalTrials.gov — NCT05793853
Locations in the U.S.
| New York | Columbia University Medical Center - Harkness Pavillion, New York |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.