NCT05793853

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Aug 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress87%
Aug 2022Dec 2026

Study Start

First participant enrolled

August 25, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 31, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

December 16, 2025

Status Verified

December 1, 2025

Enrollment Period

4.3 years

First QC Date

December 23, 2022

Last Update Submit

December 8, 2025

Conditions

Hypoparathyroidism

Outcome Measures

Primary Outcomes (1)

  • Kidney function

    blood test for changes in eGFR (in mL/min/1.73m\^2)

    baseline, 6, 12, 18, 24, 30, 36 Months

Secondary Outcomes (16)

  • Kidney calcification

    Baseline and 36 Months

  • Brain calcification

    Baseline and 36 Months

  • Vascular calcification

    Baseline and 36 Months

  • Bone mineral density

    Baseline and 36 Months

  • Bone microarchitecture and bone strength

    Baseline and 36 Months

  • +11 more secondary outcomes

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Male or female ≥18 years of age with all hypoparathyroidism sub-types. Healthy male and female controls.

You may qualify if:

  • 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.

You may not qualify if:

  • Functional HPT
  • Transient HPT
  • Pseudohypoparathyroidism
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center - Harkness Pavillion

New York, New York, 10032, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood draw

MeSH Terms

Conditions

Hypoparathyroidism

Condition Hierarchy (Ancestors)

Parathyroid DiseasesEndocrine System Diseases

Study Officials

  • Mishaela Rubin, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Noelle Texeira

CONTACT

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

Aastha Mehta

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

December 23, 2022

First Posted

March 31, 2023

Study Start

August 25, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

December 16, 2025

Record last verified: 2025-12

Locations

US(1)