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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05793853
Other study ID # AAAU3302
Secondary ID R01FD007629
Status Recruiting
Phase
First received
Last updated
Start date August 25, 2022
Est. completion date December 2026

Study information

Verified date May 2024
Source Columbia University
Contact Joana Gjeci
Phone 212-342-0132
Email jg4032@cumc.columbia.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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. Funding Source- FDA OOPD


Description:

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.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.


Recruitment information / eligibility

Status Recruiting
Enrollment 94
Est. completion date December 2026
Est. primary completion date December 2026
Accepts healthy volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - Functional HPT - Transient HPT - Pseudohypoparathyroidism - Pregnancy

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Columbia University Medical Center - Harkness Pavillion New York New York

Sponsors (1)

Lead Sponsor Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Kidney function blood test for changes in eGFR (in mL/min/1.73m^2) baseline, 6, 12, 18, 24, 30, 36 Months
Secondary 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. Baseline and 36 Months
Secondary 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. Baseline and 36 Months
Secondary 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 Baseline and 36 Months
Secondary Bone mineral density Changes in dual energy X-ray absorptiometry will be assessed in an optional imaging sub-group Baseline and 36 Months
Secondary Bone microarchitecture and bone strength Changes in high resolution peripheral quantitative computed tomography will be assessed Baseline and 36 Months
Secondary Cardiac function Changes in EKG will be assessed Baseline and 36 Months
Secondary Transcriptomic signaling for calcification Changes in microRNA will be assessed Baseline and 36 Months
Secondary 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. baseline, 6, 12, 18, 24, 30, 36 Months
Secondary Biomarkers urine 24 hour urine will be collected for changes in calcium, creatinine, total volume and protein baseline, 6, 12, 18, 24, 30, 36 Months
Secondary Dietary Intake Food frequency questionnaires will be administered to measure changes in calcium, phosphorus, vitamin D, and sodium intake baseline, 12, 24 and 36 Months
Secondary 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 baseline, 12, 24 and 36 Months
Secondary 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 baseline, 12, 24 and 36 Months
Secondary 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 baseline, 12, 24 and 36 Months
Secondary Calcioprotein Maturation Time Will be obtained through blood collection and measured in minutes and changes will be tracked through visits Baseline and 36 months
Secondary Sclerostin Will be obtained through blood collection and measured in pmol/L and changes will be tracked through visits Baseline and 36 months
Secondary FGF23 Will be obtained through blood collection and measured in pg/mL and changes will be tracked through visits Baseline and 36 months
See also
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Active, not recruiting NCT05965167 - Assess Safety and Compare PK of New Oral hPTH(1-34) Tablet Formulations vs. EBP05 Tablets and Subcutaneous Forteo Phase 1/Phase 2
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