A Registry for Participants With Chronic Hypoparathyroidism

Study Overview
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Brief Summary
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The main aim of this study is to find out the long-term safety and effectiveness profile of recombinant human parathyroid hormone (1-84) (rhPTH[1-84]) treatment in participants with chronic hypoparathyroidism under conditions of routine clinical practice. Participants will be treated according to their clinic's standard practice determined by the treating doctors. Each participant will fill out a study questionnaire during a routine doctor visit.

Official Title
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PARADIGHM (Physicians Advancing Disease Knowledge in Hypoparathyroidism): A Registry for Patients With Chronic Hypoparathyroidism

Conditions
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Hypoparathyroidism

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants diagnosed with chronic hypoparathyroidism, that is, hypoparathyroidism with a duration of longer than 6 months, including: Adult participants (greater than or equal to [>=] 18 years of age) who are receiving for chronic hypoparathyroidism any of the following options: standard therapy, standard therapy plus rhPTH(1-84), or rhPTH(1-84) therapy alone. Pediatric participants (less than [<] 18 years of age) who are receiving for chronic hypoparathyroidism any of the following options: standard therapy, standard therapy plus rhPTH(1-84), or rhPTH(1-84) therapy alone. Exclusion Criteria: Participants or legally acceptable representatives unable to provide informed consent. Participants using rhPTH(1-34) or who used rhPTH(1-34) for more than 2 years are excluded. Participants who had been treated with rhPTH(1-34) within 3 months of enrollment are also excluded as are participants currently using rhPTH(1-34). FOR US SITES ONLY: Participants treated with rhPTH(1-84) prior to the US recall may use rhPTH(1-34) only while rhPTH(1-84) is unavailable due to the recall. Participants currently enrolled in an interventional clinical study (whether or not the study is related to hypoparathyroidism); note that this does not include participants enrolled in other observational registries. History of hypoparathyroidism resulting from impaired responsiveness to PTH (pseudohypoparathyroidism).
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Natpar(a)<br>Participants receiving parathyroid hormone (rhPTH(1-84) (Natpar[a]) for treatment of chronic hypoparathyroidism as per standard clinical practice will be enrolled and evaluated during the study period. | Other: No intervention<br>* This is a non-interventional study.<br>|
| Conventional Therapy<br>Participants receiving conventional therapy/standard of care (including calcium supplements, active vitamin D, vitamin D) for treatment of chronic hypoparathyroidism as per standard clinical practice will be enrolled and evaluated during the study period. | Other: No intervention<br>* This is a non-interventional study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in 24-Hour Urine Calcium | Change from baseline in 24-hour urine calcium will be evaluated. | Baseline up to 10 years (follow-up) | 
| Change from Baseline in Serum Calcium | Change from baseline in serum calcium will be evaluated. | Baseline up to 10 years (follow-up) | 
| Change from Baseline in Serum Albumin | Change from baseline in serum albumin will be evaluated. | Baseline up to 10 years (follow-up) | 
| Change from Baseline in Albumin-Corrected Total Calcium | Change from baseline in albumin-corrected total calcium will be evaluated. | Baseline up to 10 years (follow-up) | 
| Change from Baseline in Serum Ionized Calcium | Change from baseline in serum ionized calcium will be evaluated. | Baseline up to 10 years (follow-up) | 
| Change from Baseline in Serum Magnesium | Change from baseline in serum magnesium will be evaluated. | Baseline up to 10 years (follow-up) | 
| Change from Baseline in Serum Phosphate | Change from baseline in serum phosphate will be evaluated | Baseline up to 10 years (follow-up) | 
| Change from Baseline in 25-Hydroxy (25-OH) Vitamin D results | Change from baseline in 25-OH vitamin D will be evaluated. | Baseline up to 10 years (follow-up) | 
| Change from Baseline in Serum Creatinine | Change from baseline in serum creatinine will be evaluated. | Baseline up to 10 years (follow-up) | 
| Change from Baseline in Estimated Glomerular Filtration Rate (eGFR; calculated) | Change from baseline in eGFR; calculated will be evaluated. | Baseline up to 10 years (follow-up) | 
| Change from Baseline in 24-Hour Urine Protein | Change from Baseline in 24-hour urine protein will be evaluated. | Baseline up to 10 years (follow-up) | 
| Incidence Rate of the Renal Events | Incidence rate of the renal events will be recorded for nephrolithiasis, nephrocalcinosis, hospitalization/emergency room visits for renal events. | Baseline up to 10 years (follow-up) | 
| Incidence Rate of the Soft Tissue Calcifications (site) | Incidence rate of the soft tissue calcifications (site) will be recorded. | Baseline up to 10 years (follow-up) | 
| Incidence Rate of the Cataract | Incidence rate of the cataract will be recorded by questionnaire (present/not present). | Baseline up to 10 years (follow-up) | 
| Incidence Rate of the Bone Fractures (site) | Incidence rate of the bone fractures (site) will be recorded. | Baseline up to 10 years (follow-up) | 
| Incidence Rate of the Cardiovascular Events | Incidence rate of the cardiovascular events will be calculated for this clinical outcome. Cardiovascular events include myocardial infarction, stroke, arrhythmia. | Baseline up to 10 years (follow-up) | 
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a participant administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, a new disease or worsening in severity or frequency of a concomitant disease, temporally associated with the use of a medicinal product, whether or not the event is considered causally related to the use of the product. An SAE is any untoward medical occurrence (whether considered to be related to study product or not) that at any dose results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality or birth defect, an important medical event. | Baseline up to 10 years (follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related Quality of Life (HRQoL) | Health-Related Quality of Life (HRQoL), as measured by the short-form-10 (SF-10) for pediatrics, short-form-36 (SF-36) for adults will be examined longitudinally using methods for continuous data. | Baseline up to 10 years (follow-up) | 
| Disease-specific Patient-reported Outcome Measures | Chronic hypoparathyroidism patient-reported outcome will be recorded as measured by the hypoparathyroidism multi-symptom diary (HPT-SD). | Baseline up to 10 years (follow-up) | 
| Rate of Hospitalization/Emergency Room (ER) Visits | The rate of hospitalizations and ER visits during follow-up will be summarized. | Baseline up to 10 years (follow-up) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Hypoparathyroidism, rhPTH(1-84), Observational study, parathyroid hormone (PTH), Drug registry, rhPTH(1-34)