An observational study in Hypoparathyroidism, sponsored by Columbia University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-16.
Sponsored by Columbia University · Observational
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:
Funding Source - FDA OOPD
The goal of this study is to prospectively collect data on the natural history of hypoparathyroidism (HPT). This will enable longitudinal data collection of complications in this disease, specifically defining the epidemiology of end-organ complications of HPT that are related to high calcification propensity. It will also determine relationships between calcification burden and end-organ disease severity and progression risk and assess the utility of traditional and novel biomarkers of mineral and bone metabolism on disease diagnosis and monitoring. These data will inform future investigations on the development, study, and implementation of HPT end-organ disease modifying strategies and impact clinical practice in hypoparathyroidism.
128 studies on the registry are indexed under Hypoparathyroidism; 30 are open to participants now.
This study's planned enrollment of 106 is below the median of 147 across 48 observational studies indexed under Hypoparathyroidism.
Browse Hypoparathyroidism studies →Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Male or female ≥18 years of age with all hypoparathyroidism sub-types. Healthy male and female controls.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who have the disease hypoparathyroidism, who are being followed to monitor various aspects of the disease over time. No interventions.
Healthy individuals to be followed to compare to hypoparathyroidism patients
Kidney function
blood test for changes in eGFR (in mL/min/1.73m\^2)
Time frame: baseline, 6, 12, 18, 24, 30, 36 Months
Kidney calcification
Changes in kidney calcification and stones will be assessed by abdominal CT in an optional imaging sub group. Results will be assessed and reported by a clinician.
Time frame: Baseline and 36 Months
Brain calcification
Changes in brain calcification will be assessed by head CT in an optional imaging sub-group. Results will be assessed and reported by a clinician.
Time frame: Baseline and 36 Months
Vascular calcification
Changes in vascular calcification will be assessed by leg arterial calcifications on high resolution quantitative computed tomography in all, and aortic calcifications on abdominal CT and vertebral fracture assessment by DXA in optional imaging sub-group
Time frame: Baseline and 36 Months
Bone mineral density
Changes in dual energy X-ray absorptiometry will be assessed in an optional imaging sub-group
Time frame: Baseline and 36 Months
Bone microarchitecture and bone strength
Changes in high resolution peripheral quantitative computed tomography will be assessed
Time frame: Baseline and 36 Months
Cardiac function
Changes in EKG will be assessed
Time frame: Baseline and 36 Months
Transcriptomic signaling for calcification
Changes in microRNA will be assessed
Time frame: Baseline and 36 Months
Biomarkers blood
Changes in complete metabolic panel to see changes with eGFR (including albumin-corrected serum calcium), PTH, phosphorus, magnesium, 25(OH)D, 25(OH)D2, TSH, FT4.
Time frame: baseline, 6, 12, 18, 24, 30, 36 Months
Biomarkers urine
24 hour urine will be collected for changes in calcium, creatinine, total volume and protein
Time frame: baseline, 6, 12, 18, 24, 30, 36 Months
Dietary Intake
Food frequency questionnaires will be administered to measure changes in calcium, phosphorus, vitamin D, and sodium intake
Time frame: baseline, 12, 24 and 36 Months
Cognitive Function
Changes in cognitive function will be assessed by NIH Toolbox®; Letter Fluency by the Controlled Oral Word Association Test with the letters FAS; Sematic Fluency by Animal Fluency; List Learning and Memory by the Hopkins Verbal Learning Test; subjective cognitive function by FACT-Cog
Time frame: baseline, 12, 24 and 36 Months
Neurologic Tests of Motor Function
Repeated Chair Stand (RCS) test will be administered to see how many times a patient can sit in and stand from a chair in 30 seconds and "Timed Up and Go" Test will measure how many seconds it takes for a patient to walk to assess changes in motor function
Time frame: baseline, 12, 24 and 36 Months
Quality of Life Through Self-Reported Questionnaires
Quality of life will be assessed by SF-36, FACIT-IF (self-reported fatigue), PGI-S and PGI-I (patient global impression of severity and impact), Hospital Anxiety and Depression Scale (HADS) and the HPT Symptom Diary and changes will be tracked through visits
Time frame: baseline, 12, 24 and 36 Months
Calcioprotein Maturation Time
Will be obtained through blood collection and measured in minutes and changes will be tracked through visits
Time frame: Baseline and 36 months
Sclerostin
Will be obtained through blood collection and measured in pmol/L and changes will be tracked through visits
Time frame: Baseline and 36 months
FGF23
Will be obtained through blood collection and measured in pg/mL and changes will be tracked through visits
Time frame: Baseline and 36 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Aug 2022 (actual). Primary completion is estimated for Dec 2026, 52 months after the start.
Of 25 observational studies under Hypoparathyroidism, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 122. This study's planned 52 months is above that.
How these figures are worked out, and which studies are left out of them.
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