RECRUITING

Hypoparathyroidism Natural History Study

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Conditions

Hypoparathyroidism

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Advancing Product Development for Hypoparathyroidism: A Prospective Natural History Study of the Clinical Outcomes and Regulation of Disordered Mineral Metabolism

Quick Facts

Study Start:2022-08-25
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05793853

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * An understanding, ability and willingness to fully comply with study procedures and restrictions.
  2. * Ability to voluntarily provide written, signed and dated informed consent as applicable to participate in the study.
  3. * 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.
  4. * Diagnosis of HPT established based on historic hypocalcemia in the setting of inappropriately low serum PTH levels on two occasions.
  5. * 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.
  1. * Functional HPT
  2. * Transient HPT
  3. * Pseudohypoparathyroidism
  4. * Pregnancy

Contacts and Locations

Study Contact

Noelle Texeira
CONTACT
212-305-2801
ngt2115@cumc.columbia.edu
Aastha Mehta
CONTACT
212-342-0132
am5724@cumc.columbia.edu

Principal Investigator

Mishaela Rubin, MD
PRINCIPAL_INVESTIGATOR
Columbia University

Study Locations (Sites)

Columbia University Medical Center - Harkness Pavillion
New York, New York, 10032
United States

Collaborators and Investigators

Sponsor: Columbia University

  • Mishaela Rubin, MD, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-25
Study Completion Date2026-12

Study Record Updates

Study Start Date2022-08-25
Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

  • Hypoparathyroidism