A Registry for Participants With Chronic Hypoparathyroidism
NCT ID: NCT01922440
Last Updated: 2025-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
1339 participants
OBSERVATIONAL
2013-07-30
2034-11-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Natpar(a)
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.
No intervention
This is a non-interventional study.
Conventional Therapy
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.
No intervention
This is a non-interventional study.
Interventions
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No intervention
This is a non-interventional study.
Eligibility Criteria
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Inclusion Criteria
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 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).
ALL
No
Sponsors
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Takeda Development Center Americas, Inc.
INDUSTRY
Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Arizona Medical Center
Tucson, Arizona, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Dr. Joselito Cabaccan
San Jose, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Yale University
New Haven, Connecticut, United States
Hanson Clinical Research Center
Port Charlotte, Florida, United States
Thyroid & Endocrine Center of Florida
Sarasota, Florida, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Suburban Endocrinology & Diabetes
Arlington Heights, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Northshore University Health System
Evanston, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Indiana University Hospital
Indianapolis, Indiana, United States
Tilak Mallik, MD F.A.C.E., LCC
Marrero, Louisiana, United States
Model Clinical Research
Baltimore, Maryland, United States
Medstar Union Memorial Hospital
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Harvard Medical School
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
University of Missouri
Columbia, Missouri, United States
Diabetes & Endocrine Associates, Methodist Physicians Clinic Diabetes and Endocrine Specialists
Omaha, Nebraska, United States
Palm Research Center, Inc.
Las Vegas, Nevada, United States
Northern Nevada Endocrinology
Reno, Nevada, 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
Albany Med Endocrine Specialists
Albany, New York, United States
Brokhin Medical PC
Brooklyn, New York, United States
Gerald Friedman Diabetes Institute
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Endocrine Associates of Long Island, P.C.
Smithtown, New York, 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
Mecklenburg Medical Group
Charlotte, North Carolina, United States
Physicians East, PA
Greenville, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Ohio Health Research Institute
Columbus, Ohio, United States
Endocrinology Associates of Armstrong
Indiana, Pennsylvania, 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
Hallett Center for Diabetes and Endocrinology
East Providence, Rhode Island, United States
University of South Carolina
Columbia, South Carolina, United States
Texas Diabetes and Endocrinology, P.A.
Austin, Texas, United States
Thyroid Endocrinology and Diabetes
Dallas, Texas, United States
Academy of Diabetes Thyroid and Endocrine
El Paso, Texas, United States
Diabetes and Thyroid Center of Fort Worth, PLLC
Fort Worth, Texas, United States
University of Vermont
South Burlington, Vermont, United States
University of Wisconsin
Madison, Wisconsin, United States
Medizinische Universitaetsklinik Graz, Universitätsklinik Für Innere Medizin Graz
Graz, , Austria
AKH Wien, Universitaetsklinik fuer Innere Medizin III
Vienna, , Austria
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
McMaster University
Oakville, Ontario, Canada
Aallborg University Hospital
Aalborg, , Denmark
Aarhus Universitetshospital
Aarhus N, , Denmark
Nordsjaellands Hospital - Hillerod
Hilleroed, , Denmark
Regions Hospitalet Viborg
Viborg, , Denmark
Diakonie-Klinikum Stuttgart
Stuttgart, Baden-Wurttemberg, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany
University Hospital Duesseldorf
Düsseldorf, North Rhine-Westphalia, Germany
University of Leipzig
Leipzig, Saxony, 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
Endokrinologikum Frankfurt
Frankfurt, , Germany
MVZ endokrinologikum Göttingen
Göttingen, , Germany
Universitaet Zur Luebeck
Lübeck, , Germany
Medicover Neuroendokrinologie MVZ
München, , Germany
Medicover Neu-Ulm Mvz
Neu-Ulm, , Germany
Medicover Oldenburg MVZ
Oldenburg, , Germany
Medicover Saarbuecken Mvz
Saarbrücken, , Germany
Endokrinologie Zentrum Ulm
Ulm, , Germany
Universitaetsklinikum Wuerzburg
Würzburg, , Germany
General Hospital Of Athens - Korgialenio-Benakio E.E.S.
Athens, , Greece
General Hospital of Athens Georgios Gennimatas
Athens, , Greece
General Hospital of Athens Alexandra
Athens, , Greece
AHEPA University General Hospital of Thessaloniki
Thessaloniki, , Greece
Hippokrateion General Hospital of Thessaloniki
Thessaloniki, , Greece
Azienda Ospedaliero-Universitaria Careggi
Florence, , Italy
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
Milan, , Italy
Azienda Ospedaliera San Giovanni Addolorata
Roma, , Italy
Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza - Ospedale Molinette
Torino, , Italy
Haukeland University Hospital
Bergen, , Norway
Spesialistsentret Pilestredet Park
Oslo, , Norway
Hospital Del Mar
Barcelona, , Spain
Hospital Universitario San Cecilio
Granada, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Universitetssjukhuset I Linkoping
Linköping, , Sweden
Universitetssjukhuset I Orebro
Örebro, , Sweden
Karolinska Universitetssjukhuset Solna
Stockholm, , Sweden
Akademiska Sjukhuset - Uppsala University Hospital
Uppsala, , Sweden
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 Kingdom
Countries
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References
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Gittoes N, Rejnmark L, Ing SW, Brandi ML, Bjornsdottir S, Hahner S, Hofbauer LC, Houillier P, Khan AA, Levine MA, Mannstadt M, Shoback DM, Vokes TJ, Zhang P, Marelli C, Germak J, Clarke BL. The PARADIGHM (physicians advancing disease knowledge in hypoparathyroidism) registry for patients with chronic hypoparathyroidism: study protocol and interim baseline patient characteristics. BMC Endocr Disord. 2021 Nov 20;21(1):232. doi: 10.1186/s12902-021-00888-2.
Related Links
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To obtain more information on the study, click here/on this link
Other Identifiers
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EUPAS16927
Identifier Type: OTHER
Identifier Source: secondary_id
PAR-R13-001
Identifier Type: -
Identifier Source: org_study_id
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