Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
106 participants
OBSERVATIONAL
2022-08-25
2026-12-31
Brief Summary
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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
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Hypoparathyroidism Subjects
Patients who have the disease hypoparathyroidism, who are being followed to monitor various aspects of the disease over time. No interventions.
No interventions assigned to this group
Control Subjects
Healthy individuals to be followed to compare to hypoparathyroidism patients
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* Transient HPT
* Pseudohypoparathyroidism
* Pregnancy
18 Years
100 Years
ALL
Yes
Sponsors
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Columbia University
OTHER
Responsible Party
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Mishaela Rubin
Professor of Medicine
Principal Investigators
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Mishaela Rubin, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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Columbia University Medical Center - Harkness Pavillion
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AAAU3302
Identifier Type: -
Identifier Source: org_study_id