NCT05793853 Hypoparathyroidism Natural History Study
| NCT ID | NCT05793853 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | Hypoparathyroidism |
| Study Type | OBSERVATIONAL |
| Enrollment | 106 participants |
| Start Date | 2022-08-25 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 106 participants in total. It began in 2022-08-25 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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
Eligibility Criteria
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
Contact & Investigator
Mishaela Rubin, MD
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT05793853 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Hypoparathyroidism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05793853 currently recruiting?
Yes, NCT05793853 is actively recruiting participants. Contact the research team at ngt2115@cumc.columbia.edu for enrollment information.
Where is the NCT05793853 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05793853 clinical trial?
NCT05793853 is sponsored by Columbia University. The principal investigator is Mishaela Rubin, MD at Columbia University. The trial plans to enroll 106 participants.