HypoparathyroidismSHINENCT05793853
Hypoparathyroidism Natural History Study
An observational study of Hypoparathyroidism, run by Columbia University at 1 site in United States.
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. The study objectives are to: 1. Build a prospective cohort of patients to study HPT-associated end-organ damage. 2. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoparathyroidism
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2022to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male or female ≥18 years of age with all hypoparathyroidism sub-types. Healthy male and female controls.
Who may be able to join
- 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.
Who cannot join
- Functional HPT
- Transient HPT
- Pseudohypoparathyroidism
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University Medical Center - Harkness Pavillion
New York, New York, 10032
Noelle Texeira, 212-305-2801, ngt2115@cumc.columbia.edu
Mishaela Rubin, MD
About this study
Official title: Advancing Product Development for Hypoparathyroidism: A Prospective Natural History Study of the Clinical Outcomes and Regulation of Disordered Mineral Metabolism
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:
- Build a prospective cohort of patients to study HPT-associated end-organ damage.
- Determine end-organ physiologic consequences of HPT.
- Elucidate determinants of HPT-associated end-organ damage.
Funding Source - FDA OOPD
Read the detailed 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.
- Conditions
- Hypoparathyroidism
- Medical subject headings
- Hypoparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hypoparathyroidism Subjects | Patients who have the disease hypoparathyroidism, who are being followed to monitor various aspects of the disease over time. No interventions. | |
| Control Subjects | Healthy individuals to be followed to compare to hypoparathyroidism patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kidney function
blood test for changes in eGFR (in mL/min/1.73m^2)
Measured: baseline, 6, 12, 18, 24, 30, 36 Months
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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
Measured: Baseline and 36 Months
Bone mineral density
Changes in dual energy X-ray absorptiometry will be assessed in an optional imaging sub-group
Measured: Baseline and 36 Months
Bone microarchitecture and bone strength
Changes in high resolution peripheral quantitative computed tomography will be assessed
Measured: Baseline and 36 Months
Cardiac function
Changes in EKG will be assessed
Measured: Baseline and 36 Months
Transcriptomic signaling for calcification
Changes in microRNA will be assessed
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline and 36 months
Sclerostin
Will be obtained through blood collection and measured in pmol/L and changes will be tracked through visits
Measured: Baseline and 36 months
FGF23
Will be obtained through blood collection and measured in pg/mL and changes will be tracked through visits
Measured: Baseline and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start25 Aug 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoparathyroidismStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mishaela Rubin, Columbia University
- Investigators
- Mishaela Rubin, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05793853
- Sponsor's protocol ID
- AAAU3302
- Other IDs
- R01FD007629
- Acronym
- SHINE
- Status last verified
- Dec 2025
- First submitted
- 23 Dec 2022
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Product Development for Hypoparathyroidism: A Prospective Natural History Study of the Clinical Outcomes and Regulation of Disordered Mineral Metabolism
- ClinicalTrials.gov ID
- NCT05793853
- Acronym / sponsor ID
- SHINE / AAAU3302
- Conditions
- Hypoparathyroidism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 25 Aug 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Build a prospective cohort of patients to study HPT-associated end-organ damage.
- Determine end-organ physiologic consequences of HPT.
- Elucidate determinants of HPT-associated end-organ damage.
Funding Source - FDA OOPD
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypoparathyroidism Subjects | – | –Patients who have the disease hypoparathyroidism, who are being followed to monitor various aspects of the disease over time. No interventions. |
| Control Subjects | – | –Healthy individuals to be followed to compare to hypoparathyroidism patients |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female ≥18 years of age with all hypoparathyroidism sub-types. Healthy male and female controls.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Functional HPT
- Transient HPT
- Pseudohypoparathyroidism
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Kidney function
Time frame: baseline, 6, 12, 18, 24, 30, 36 Months
blood test for changes in eGFR (in mL/min/1.73m^2)
16 secondary outcomes
Kidney calcification
Time frame: Baseline and 36 Months
Brain calcification
Time frame: Baseline and 36 Months
Vascular calcification
Time frame: Baseline and 36 Months
Bone mineral density
Time frame: Baseline and 36 Months
Bone microarchitecture and bone strength
Time frame: Baseline and 36 Months
Cardiac function
Time frame: Baseline and 36 Months
Transcriptomic signaling for calcification
Time frame: Baseline and 36 Months
Biomarkers blood
Time frame: baseline, 6, 12, 18, 24, 30, 36 Months
Biomarkers urine
Time frame: baseline, 6, 12, 18, 24, 30, 36 Months
Dietary Intake
Time frame: baseline, 12, 24 and 36 Months
Cognitive Function
Time frame: baseline, 12, 24 and 36 Months
Neurologic Tests of Motor Function
Time frame: baseline, 12, 24 and 36 Months
Quality of Life Through Self-Reported Questionnaires
Time frame: baseline, 12, 24 and 36 Months
Calcioprotein Maturation Time
Time frame: Baseline and 36 months
Sclerostin
Time frame: Baseline and 36 months
FGF23
Time frame: Baseline and 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mishaela Rubin, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoparathyroidism, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noelle Texeira (212-305-2801, ngt2115@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kidney function (time frame: baseline, 6, 12, 18, 24, 30, 36 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.