Hypoparathyroidism Natural History Study
ConditionHypoparathyroidism
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorColumbia University
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Functional HPT
Transient HPT
Pseudohypoparathyroidism
Pregnancy
Trial population
Male or female ≥18 years of age with all hypoparathyroidism sub-types. Healthy male and female controls.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
106 Participants
are grouped into 2 trial groupsGroup A: Hypoparathyroidism Subjects
Group B: Control Subjects
Trial outcomes
Primary outcomes
1
Kidney function
blood test for changes in eGFR (in mL/min/1.73m\^2)
Time frame
baseline, 6, 12, 18, 24, 30, 36 MonthsSecondary outcomes
1
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 Months2
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 Months3
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 Months4
Bone mineral density
Changes in dual energy X-ray absorptiometry will be assessed in an optional imaging sub-group
Time frame
Baseline and 36 MonthsSponsors and contacts
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Source ClinicalTrials.gov