A Registry for Participants With Chronic Hypoparathyroidism

Hypoparathyroidism Clinical Trial

— PARADIGHM  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01922440
• Other study ID #: PAR-R13-001
• Secondary ID: EUPAS16927
• Status: Active, not recruiting
• Start date: July 30, 2013
• Est. completion date: November 30, 2034

Study information

• Verified date: March 2024
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1340
• Est. completion date: November 30, 2034
• Est. primary completion date: November 30, 2034
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Participants diagnosed with chronic hypoparathyroidism, that is, hypoparathyroidism with a duration of longer than 6 months, including:

1. 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.

2. 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).

Related Conditions & MeSH terms

• Hypoparathyroidism

Intervention

Other:
• No intervention
This is a non-interventional study.

Locations

Country	Name	City	State
Austria	Medizinische Universitaetsklinik Graz, Universitätsklinik Für Innere Medizin Graz	Graz
Austria	AKH Wien, Universitaetsklinik fuer Innere Medizin III	Wien
Canada	Nova Scotia Health Authority	Halifax	Nova Scotia
Canada	McMaster University	Oakville	Ontario
Denmark	Aallborg University Hospital	Aalborg
Denmark	Aarhus Universitetshospital	Aarhus N
Denmark	Nordsjaellands Hospital - Hillerod	Hilleroed
Denmark	Regions Hospitalet Viborg	Viborg
Germany	Universitaetsklinik Aachen	Aachen
Germany	Charite-Universitiitsmedizin Berlin (CCM)	Berlin
Germany	Praxis an der Kaiserreiche	Berlin
Germany	Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden	Dresden
Germany	University Hospital Duesseldorf	Dusseldorf	Nordrhein-Westfalen
Germany	Endokrinologikum Frankfurt	Frankfurt
Germany	MVZ endokrinologikum Göttingen	Göttingen
Germany	Medizinische Hochschule Hannover	Hannover	Lower Saxony
Germany	University of Leipzig	Leipzig	Sachsen
Germany	Universitaet Zur Luebeck	Luebeck
Germany	Medicover Neuroendokrinologie MVZ	Muenchen
Germany	Medicover Neu-Ulm Mvz	Neu-Ulm
Germany	Medicover Oldenburg MVZ	Oldenburg
Germany	Medicover Saarbuecken Mvz	Saarbruecken
Germany	Diakonie-Klinikum Stuttgart	Stuttgart	Baden-Wuerttemberg
Germany	Endokrinologie Zentrum Ulm	Ulm
Germany	Universitaetsklinikum Wuerzburg	Wuerzburg
Greece	General Hospital Of Athens - Korgialenio-Benakio E.E.S.	Athens
Greece	General Hospital of Athens Alexandra	Athens
Greece	General Hospital of Athens Georgios Gennimatas	Athens
Greece	AHEPA University General Hospital of Thessaloniki	Thessaloniki
Greece	Hippokrateion General Hospital of Thessaloniki	Thessaloniki
Italy	Azienda Ospedaliero-Universitaria Careggi	Firenze
Italy	Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico	Milano
Italy	Azienda Ospedaliera San Giovanni Addolorata	Roma
Italy	Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza - Ospedale Molinette	Torino
Norway	Haukeland University Hospital	Bergen
Norway	Spesialistsentret Pilestredet Park	Oslo
Spain	Hospital Del Mar	Barcelona
Spain	Hospital Universitario San Cecilio	Granada
Spain	Hospital Universitario 12 de Octubre	Madrid
Sweden	Universitetssjukhuset I Linkoping	Linkoping
Sweden	Universitetssjukhuset I Orebro	Orebro
Sweden	Karolinska Universitetssjukhuset Solna	Stockholm
Sweden	Akademiska Sjukhuset - Uppsala University Hospital	Uppsala
United Kingdom	Queen Elizabeth Hospital-Mindelsohn Way	Birmingham	England
United Kingdom	University of Hospitals of Leicester	Leicester
United Kingdom	Norfolk And Norwich University Hospital - Norwich Medical School	Norwich
United States	Albany Med Endocrine Specialists	Albany	New York
United States	Suburban Endocrinology & Diabetes	Arlington Heights	Illinois
United States	University of Colorado Hospital	Aurora	Colorado
United States	Texas Diabetes and Endocrinology, P.A.	Austin	Texas
United States	Medstar Union Memorial Hospital	Baltimore	Maryland
United States	Model Clinical Research	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Boston Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Harvard Medical School	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Brokhin Medical PC	Brooklyn	New York
United States	Mecklenburg Medical Group	Charlotte	North Carolina
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	University of Missouri	Columbia	Missouri
United States	University of South Carolina	Columbia	South Carolina
United States	Ohio Health Research Institute	Columbus	Ohio
United States	Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Thyroid Endocrinology and Diabetes	Dallas	Texas
United States	Hallett Center for Diabetes and Endocrinology	East Providence	Rhode Island
United States	Academy of Diabetes Thyroid and Endocrine	El Paso	Texas
United States	Northshore University Health System	Evanston	Illinois
United States	Diabetes and Thyroid Center of Fort Worth, PLLC	Fort Worth	Texas
United States	Physicians East, PA	Greenville	North Carolina
United States	East-West Medical Research Institute	Honolulu	Hawaii
United States	Endocrinology Associates of Armstrong	Indiana	Pennsylvania
United States	Indiana University Hospital	Indianapolis	Indiana
United States	Palm Research Center, Inc.	Las Vegas	Nevada
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	University of Wisconsin	Madison	Wisconsin
United States	Tilak Mallik, MD F.A.C.E., LCC	Marrero	Louisiana
United States	Loyola University Medical Center	Maywood	Illinois
United States	University of Minnesota	Minneapolis	Minnesota
United States	Rutgers Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Rutgers-Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Yale University	New Haven	Connecticut
United States	Columbia University Medical Center	New York	New York
United States	Gerald Friedman Diabetes Institute	New York	New York
United States	Diabetes & Endocrine Associates, Methodist Physicians Clinic Diabetes and Endocrine Specialists	Omaha	Nebraska
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Alleghany General Hospital	Pittsburgh	Pennsylvania
United States	Hanson Clinical Research Center	Port Charlotte	Florida
United States	Northern Nevada Endocrinology	Reno	Nevada
United States	Mayo Clinic - Rochester	Rochester	Minnesota
United States	Dr. Joselito Cabaccan	San Jose	California
United States	Thyroid & Endocrine Center of Florida	Sarasota	Florida
United States	Endocrine Associates of Long Island, P.C.	Smithtown	New York
United States	University of Vermont	South Burlington	Vermont
United States	University Physicians Group Research Division	Staten Island	New York
United States	State University Of New York Upstate Medical University	Syracuse	New York
United States	University of Arizona Medical Center	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Takeda	Takeda Development Center Americas, Inc.

Countries where clinical trial is conducted

United States,  Austria,  Canada,  Denmark,  Germany,  Greece,  Italy,  Norway,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Change from Baseline in Serum Calcium	Change from baseline in serum calcium will be evaluated.	Baseline up to 10 years (follow-up)
Primary	Change from Baseline in Serum Albumin	Change from baseline in serum albumin will be evaluated.	Baseline up to 10 years (follow-up)
Primary	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)
Primary	Change from Baseline in Serum Ionized Calcium	Change from baseline in serum ionized calcium will be evaluated.	Baseline up to 10 years (follow-up)
Primary	Change from Baseline in Serum Magnesium	Change from baseline in serum magnesium will be evaluated.	Baseline up to 10 years (follow-up)
Primary	Change from Baseline in Serum Phosphate	Change from baseline in serum phosphate will be evaluated	Baseline up to 10 years (follow-up)
Primary	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)
Primary	Change from Baseline in Serum Creatinine	Change from baseline in serum creatinine will be evaluated.	Baseline up to 10 years (follow-up)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	Incidence Rate of the Bone Fractures (site)	Incidence rate of the bone fractures (site) will be recorded.	Baseline up to 10 years (follow-up)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)

External Links

•   To obtain more information on the study, click here/on this link