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Completed

NCT Number: NCT01922440

A Registry for Participants With Chronic Hypoparathyroidism

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.

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Key information

Conditions

Hypoparathyroidism Endocrine System Diseases Parathyroid Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Medizinische Universitaetsklinik Graz, Universitätsklinik Für Innere Medizin Graz, Graz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

No intervention

Other

This is a non-interventional study.

Primary outcomes

  1. Change from Baseline in 24-Hour Urine Calcium

    Time frame: Baseline up to 10 years (follow-up)

    Change from baseline in 24-hour urine calcium will be evaluated.

  2. Change from Baseline in Serum Calcium

    Time frame: Baseline up to 10 years (follow-up)

    Change from baseline in serum calcium will be evaluated.

  3. Change from Baseline in Serum Albumin

    Time frame: Baseline up to 10 years (follow-up)

    Change from baseline in serum albumin will be evaluated.

  4. Change from Baseline in Albumin-Corrected Total Calcium

    Time frame: Baseline up to 10 years (follow-up)

    Change from baseline in albumin-corrected total calcium will be evaluated.

  5. Change from Baseline in Serum Ionized Calcium

    Time frame: Baseline up to 10 years (follow-up)

    Change from baseline in serum ionized calcium will be evaluated.

  6. Change from Baseline in Serum Magnesium

    Time frame: Baseline up to 10 years (follow-up)

    Change from baseline in serum magnesium will be evaluated.

  7. Change from Baseline in Serum Phosphate

    Time frame: Baseline up to 10 years (follow-up)

    Change from baseline in serum phosphate will be evaluated

  8. Change from Baseline in 25-Hydroxy (25-OH) Vitamin D results

    Time frame: Baseline up to 10 years (follow-up)

    Change from baseline in 25-OH vitamin D will be evaluated.

  9. Change from Baseline in Serum Creatinine

    Time frame: Baseline up to 10 years (follow-up)

    Change from baseline in serum creatinine will be evaluated.

  10. Change from Baseline in Estimated Glomerular Filtration Rate (eGFR; calculated)

    Time frame: Baseline up to 10 years (follow-up)

    Change from baseline in eGFR; calculated will be evaluated.

  11. Change from Baseline in 24-Hour Urine Protein

    Time frame: Baseline up to 10 years (follow-up)

    Change from Baseline in 24-hour urine protein will be evaluated.

  12. Incidence Rate of the Renal Events

    Time frame: Baseline up to 10 years (follow-up)

    Incidence rate of the renal events will be recorded for nephrolithiasis, nephrocalcinosis, hospitalization/emergency room visits for renal events.

  13. Incidence Rate of the Soft Tissue Calcifications (site)

    Time frame: Baseline up to 10 years (follow-up)

    Incidence rate of the soft tissue calcifications (site) will be recorded.

  14. Incidence Rate of the Cataract

    Time frame: Baseline up to 10 years (follow-up)

    Incidence rate of the cataract will be recorded by questionnaire (present/not present).

  15. Incidence Rate of the Bone Fractures (site)

    Time frame: Baseline up to 10 years (follow-up)

    Incidence rate of the bone fractures (site) will be recorded.

  16. Incidence Rate of the Cardiovascular Events

    Time frame: Baseline up to 10 years (follow-up)

    Incidence rate of the cardiovascular events will be calculated for this clinical outcome. Cardiovascular events include myocardial infarction, stroke, arrhythmia.

  17. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Baseline up to 10 years (follow-up)

    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.

Secondary outcomes

  1. Health-related Quality of Life (HRQoL)

    Time frame: Baseline up to 10 years (follow-up)

    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.

  2. Disease-specific Patient-reported Outcome Measures

    Time frame: Baseline up to 10 years (follow-up)

    Chronic hypoparathyroidism patient-reported outcome will be recorded as measured by the hypoparathyroidism multi-symptom diary (HPT-SD).

  3. Rate of Hospitalization/Emergency Room (ER) Visits

    Time frame: Baseline up to 10 years (follow-up)

    The rate of hospitalizations and ER visits during follow-up will be summarized.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Collaborators

  • Takeda Development Center Americas, Inc.

Registry information

Official study title

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

Acronym: PARADIGHM

Important dates

Study start
2013
Primary completion
2026
Study completion
2026
First posted
Aug 14, 2013
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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