Actively Recruiting
Advancing Product Development for Hypoparathyroidism: A Prospective Natural History Study of Clinical Outcomes and Mineral Metabolism Regulation
Led by Columbia University · Updated on 2025-12-16
106
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a three-year prospective natural history study focused on adults with hypoparathyroidism (HPT). The study aims to monitor patients to better understand the damage this disease may cause to various organs over time. Objectives include building a patient group to study organ damage related to HPT, determining how the disease affects organ function, and identifying factors that contribute to this damage. Participants include adults diagnosed with any subtype of hypoparathyroidism, as well as healthy individuals for comparison. There are no treatments or interventions given; instead, patients are observed and monitored over time. The study collects longitudinal data on complications, especially those linked to calcification in organs. It also evaluates various biomarkers related to mineral and bone metabolism to improve diagnosis and monitoring of the disease. Participants will be followed for up to three years with assessments at baseline and regular intervals including 6, 12, 18, 24, 30, and 36 months. Evaluations include kidney function, organ calcification (kidney, brain, vascular), bone density and strength, heart function, biomarkers from blood and urine, dietary intake, cognitive and motor function tests, and quality of life questionnaires. This comprehensive monitoring will help define disease progression and inform future treatment research.
CONDITIONS
Brief Title
Hypoparathyroidism Natural History Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understanding, ability, and willingness to fully comply with study procedures and restrictions
- Ability to voluntarily provide written, signed, and dated informed consent
- Male or female 18 years of age or older with hypoparathyroidism (all subtypes, including surgical and nonsurgical forms)
- Diagnosis of hypoparathyroidism based on historic low calcium and low serum PTH levels on two occasions
- All treatment regimens are permitted, including calcium supplements, vitamin D forms, magnesium, phosphate binders, thiazides, and PTH-like drugs
You will not qualify if you...
- Functional hypoparathyroidism
- Transient hypoparathyroidism
- Pseudohypoparathyroidism
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 36 months
Participants with hypoparathyroidism and healthy controls are followed over time to monitor kidney function, calcification, bone health, cardiac function, biomarkers, cognitive and neurologic function, and quality of life.
Visits at baseline, 6, 12, 18, 24, 30, and 36 months with additional assessments at 12, 24, and 36 months for dietary intake, cognitive function, neurologic motor tests, and quality of life questionnaires
Trial Site Locations
Total: 1 location
1
Columbia University Medical Center - Harkness Pavillion
New York, New York, United States, 10032
Actively Recruiting
Research Team
N
Noelle Texeira
A
Aastha Mehta
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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