An observational study in Hypoparathyroidism, sponsored by Takeda. Completed at 100 sites in 11 countries. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by Takeda · Observational
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.
128 studies on the registry are indexed under Hypoparathyroidism; 30 are open to participants now.
This study's enrollment of 1,339 is above the median of 147 across 48 observational studies indexed under Hypoparathyroidism.
Browse Hypoparathyroidism studies →Takeda is the lead sponsor of 1,026 studies on the registry; 89 are open to participants now.
Of its 178 completed or terminated interventional studies of FDA-regulated products, 154 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
This global registry is expected to enroll a minimum of 900 participants, of whom at least 300 will be participants treated with rhPTH(1-84) and at least 600 will be participants receiving standard of care. Protocol amendment 9 revised the sample size: up to 164 additional participants treated with rhPTH(1-84) (ie, up to a total of 464 participants in that cohort) will be enrolled as needed to ensure the availability of 104 rhPTH(1-84)-treated participants with a full 10 years of follow-up.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants diagnosed with chronic hypoparathyroidism, that is, hypoparathyroidism with a duration of longer than 6 months, including:
Exclusion Criteria:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
This is a non-interventional study.
Change from Baseline in 24-Hour Urine Calcium
Change from baseline in 24-hour urine calcium will be evaluated.
Time frame: Baseline up to 10 years (follow-up)
Change from Baseline in Serum Calcium
Change from baseline in serum calcium will be evaluated.
Time frame: Baseline up to 10 years (follow-up)
Change from Baseline in Serum Albumin
Change from baseline in serum albumin will be evaluated.
Time frame: 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.
Time frame: Baseline up to 10 years (follow-up)
Change from Baseline in Serum Ionized Calcium
Change from baseline in serum ionized calcium will be evaluated.
Time frame: Baseline up to 10 years (follow-up)
Change from Baseline in Serum Magnesium
Change from baseline in serum magnesium will be evaluated.
Time frame: Baseline up to 10 years (follow-up)
Change from Baseline in Serum Phosphate
Change from baseline in serum phosphate will be evaluated
Time frame: 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.
Time frame: Baseline up to 10 years (follow-up)
Change from Baseline in Serum Creatinine
Change from baseline in serum creatinine will be evaluated.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Baseline up to 10 years (follow-up)
Incidence Rate of the Bone Fractures (site)
Incidence rate of the bone fractures (site) will be recorded.
Time frame: 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.
Time frame: 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.
Time frame: Baseline up to 10 years (follow-up)
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.
Time frame: 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).
Time frame: 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.
Time frame: Baseline up to 10 years (follow-up)
Ran from Jul 2013 to primary completion in Jun 2026, 155 months.
Of 25 observational studies under Hypoparathyroidism, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 122. This study's 155 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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