A Registry for Participants With Chronic Hypoparathyroidism

NCT ID: NCT01922440

Last Updated: 2025-09-29

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1339 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-30

Study Completion Date

2034-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hypoparathyroidism

Study Design

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Observational Model Type

OTHER

Study Time Perspective

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

Intervention Type OTHER

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

Intervention Type OTHER

This is a non-interventional study.

Interventions

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No intervention

This is a non-interventional study.

Intervention Type OTHER

Eligibility Criteria

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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).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda Development Center Americas, Inc.

INDUSTRY

Sponsor Role collaborator

Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

University of Arizona Medical Center

Tucson, Arizona, United States

Site Status

Children's Hospital Los Angeles

Los Angeles, California, United States

Site Status

Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status

Dr. Joselito Cabaccan

San Jose, California, United States

Site Status

University of Colorado Hospital

Aurora, Colorado, United States

Site Status

Yale University

New Haven, Connecticut, United States

Site Status

Hanson Clinical Research Center

Port Charlotte, Florida, United States

Site Status

Thyroid & Endocrine Center of Florida

Sarasota, Florida, United States

Site Status

East-West Medical Research Institute

Honolulu, Hawaii, United States

Site Status

Suburban Endocrinology & Diabetes

Arlington Heights, Illinois, United States

Site Status

University of Chicago Medical Center

Chicago, Illinois, United States

Site Status

Northshore University Health System

Evanston, Illinois, United States

Site Status

Loyola University Medical Center

Maywood, Illinois, United States

Site Status

Indiana University Hospital

Indianapolis, Indiana, United States

Site Status

Tilak Mallik, MD F.A.C.E., LCC

Marrero, Louisiana, United States

Site Status

Model Clinical Research

Baltimore, Maryland, United States

Site Status

Medstar Union Memorial Hospital

Baltimore, Maryland, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Harvard Medical School

Boston, Massachusetts, United States

Site Status

Boston Medical Center

Boston, Massachusetts, United States

Site Status

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Site Status

University of Missouri

Columbia, Missouri, United States

Site Status

Diabetes & Endocrine Associates, Methodist Physicians Clinic Diabetes and Endocrine Specialists

Omaha, Nebraska, United States

Site Status

Palm Research Center, Inc.

Las Vegas, Nevada, United States

Site Status

Northern Nevada Endocrinology

Reno, Nevada, United States

Site Status

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Site Status

Rutgers-Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Site Status

Albany Med Endocrine Specialists

Albany, New York, United States

Site Status

Brokhin Medical PC

Brooklyn, New York, United States

Site Status

Gerald Friedman Diabetes Institute

New York, New York, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

Endocrine Associates of Long Island, P.C.

Smithtown, New York, United States

Site Status

University Physicians Group Research Division

Staten Island, New York, United States

Site Status

State University Of New York Upstate Medical University

Syracuse, New York, United States

Site Status

Mecklenburg Medical Group

Charlotte, North Carolina, United States

Site Status

Physicians East, PA

Greenville, North Carolina, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Site Status

Ohio Health Research Institute

Columbus, Ohio, United States

Site Status

Endocrinology Associates of Armstrong

Indiana, Pennsylvania, United States

Site Status

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

Alleghany General Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Hallett Center for Diabetes and Endocrinology

East Providence, Rhode Island, United States

Site Status

University of South Carolina

Columbia, South Carolina, United States

Site Status

Texas Diabetes and Endocrinology, P.A.

Austin, Texas, United States

Site Status

Thyroid Endocrinology and Diabetes

Dallas, Texas, United States

Site Status

Academy of Diabetes Thyroid and Endocrine

El Paso, Texas, United States

Site Status

Diabetes and Thyroid Center of Fort Worth, PLLC

Fort Worth, Texas, United States

Site Status

University of Vermont

South Burlington, Vermont, United States

Site Status

University of Wisconsin

Madison, Wisconsin, United States

Site Status

Medizinische Universitaetsklinik Graz, Universitätsklinik Für Innere Medizin Graz

Graz, , Austria

Site Status

AKH Wien, Universitaetsklinik fuer Innere Medizin III

Vienna, , Austria

Site Status

Nova Scotia Health Authority

Halifax, Nova Scotia, Canada

Site Status

McMaster University

Oakville, Ontario, Canada

Site Status

Aallborg University Hospital

Aalborg, , Denmark

Site Status

Aarhus Universitetshospital

Aarhus N, , Denmark

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Nordsjaellands Hospital - Hillerod

Hilleroed, , Denmark

Site Status

Regions Hospitalet Viborg

Viborg, , Denmark

Site Status

Diakonie-Klinikum Stuttgart

Stuttgart, Baden-Wurttemberg, Germany

Site Status

Medizinische Hochschule Hannover

Hanover, Lower Saxony, Germany

Site Status

University Hospital Duesseldorf

Düsseldorf, North Rhine-Westphalia, Germany

Site Status

University of Leipzig

Leipzig, Saxony, Germany

Site Status

Universitaetsklinik Aachen

Aachen, , Germany

Site Status

Charite-Universitiitsmedizin Berlin (CCM)

Berlin, , Germany

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Praxis an der Kaiserreiche

Berlin, , Germany

Site Status

Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden

Dresden, , Germany

Site Status

Endokrinologikum Frankfurt

Frankfurt, , Germany

Site Status

MVZ endokrinologikum Göttingen

Göttingen, , Germany

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Universitaet Zur Luebeck

Lübeck, , Germany

Site Status

Medicover Neuroendokrinologie MVZ

München, , Germany

Site Status

Medicover Neu-Ulm Mvz

Neu-Ulm, , Germany

Site Status

Medicover Oldenburg MVZ

Oldenburg, , Germany

Site Status

Medicover Saarbuecken Mvz

Saarbrücken, , Germany

Site Status

Endokrinologie Zentrum Ulm

Ulm, , Germany

Site Status

Universitaetsklinikum Wuerzburg

Würzburg, , Germany

Site Status

General Hospital Of Athens - Korgialenio-Benakio E.E.S.

Athens, , Greece

Site Status

General Hospital of Athens Georgios Gennimatas

Athens, , Greece

Site Status

General Hospital of Athens Alexandra

Athens, , Greece

Site Status

AHEPA University General Hospital of Thessaloniki

Thessaloniki, , Greece

Site Status

Hippokrateion General Hospital of Thessaloniki

Thessaloniki, , Greece

Site Status

Azienda Ospedaliero-Universitaria Careggi

Florence, , Italy

Site Status

Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

Milan, , Italy

Site Status

Azienda Ospedaliera San Giovanni Addolorata

Roma, , Italy

Site Status

Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza - Ospedale Molinette

Torino, , Italy

Site Status

Haukeland University Hospital

Bergen, , Norway

Site Status

Spesialistsentret Pilestredet Park

Oslo, , Norway

Site Status

Hospital Del Mar

Barcelona, , Spain

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Hospital Universitario San Cecilio

Granada, , Spain

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Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status

Universitetssjukhuset I Linkoping

Linköping, , Sweden

Site Status

Universitetssjukhuset I Orebro

Örebro, , Sweden

Site Status

Karolinska Universitetssjukhuset Solna

Stockholm, , Sweden

Site Status

Akademiska Sjukhuset - Uppsala University Hospital

Uppsala, , Sweden

Site Status

Queen Elizabeth Hospital-Mindelsohn Way

Birmingham, England, United Kingdom

Site Status

University of Hospitals of Leicester

Leicester, , United Kingdom

Site Status

Norfolk And Norwich University Hospital - Norwich Medical School

Norwich, , United Kingdom

Site Status

Countries

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

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.

Reference Type DERIVED
PMID: 34801015 (View on PubMed)

Related Links

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https://clinicaltrials.takeda.com/study-detail/5f6b5fd14db2bf003ab46a03

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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