A Registry for Patients With Chronic Hypoparathyroidism (PARADIGHM)
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|ClinicalTrials.gov Identifier: NCT01922440|
Recruitment Status : Recruiting
First Posted : August 14, 2013
Last Update Posted : March 30, 2018
|Condition or disease||Intervention/treatment|
|Chronic Hypoparathyroidism||Drug: Combination product (Natpara) and drug or supplements [Disease and drug registry]|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||900 participants|
|Target Follow-Up Duration:||10 Years|
|Official Title:||PARADIGHM (Physicians Advancing Disease Knowledge in Hypoparathyroidism): A Registry for Patients With Chronic Hypoparathyroidism|
|Actual Study Start Date :||July 1, 2013|
|Estimated Primary Completion Date :||June 30, 2035|
|Estimated Study Completion Date :||June 30, 2035|
A rare disease with a duration of longer than 6 months characterized by insufficient parathyroid hormone (PTH) secretion, which can result in hypocalcemia, hyperphosphatemia, and associated clinical findings.
Drug: Combination product (Natpara) and drug or supplements [Disease and drug registry]
Interventions evaluated are combination product (Natpara) and either drug or supplements (Calcium and vitamin D)
- Hypoparathyroidism Laboratory Test [ Time Frame: Baseline up to 10 years (follow-up) ]Hypoparathyroidism laboratory tests will be evaluated as change over time for 24-hour urine calcium, serum calcium, serum magnesium, serum phosphate and 25-OH vitamin D.
- Clinical Laboratory Test Results [ Time Frame: Baseline up to 10 years (follow-up) ]Results of laboratory tests collected per standard of care.
- Renal Function [ Time Frame: Baseline up to 10 years (follow-up) ]Renal function will be evaluated as change over time for serum creatinine, estimated glomerular filtration rate (eGFR; calculated), 24-hour urine calcium and 24 hour urine protein.
- 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.
- 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.
- 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).
- 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.
- 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.
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 10 years (follow-up) ]An adverse event (AE) is any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in the registry, whether or not considered product-related. This includes an exacerbation of a pre - existing condition. An AE that meets one or m ore of the following criteria/outcomes is classified as SAE whether considered to be related to the pharmaceutical product or not: death, life-threatening, requires in patient hospitalization or prolongation of existing hospitalizations, a persistent or significant disability or incapacity, a congenital anomaly or birth defect and important medical events.
- 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.
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01922440
|Contact: Shire Contactfirstname.lastname@example.org|
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|Study Director:||Shire Study Physician||Shire|