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A Registry for Participants With Chronic Hypoparathyroidism

IDENTIFIERS
Trial Protocol: PAR-R13-001
Clinicaltrials.gov: NCT01922440
EUPAS: EUPAS16927
PURPOSE

This is a prospective, observational disease and drug registry designed to evaluate the safety and effectiveness profile of rhPTH(1-84) under conditions of routine clinical practice and to observe the clinical course of chronic hypoparathyrodism. No treatment is provided as a result of participating in this registry and all decisions on the participant's treatment are determined by his or her physician.

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Trial at a glance

What medical condition is being studied?   Hypoparathyroidism
What is the trial testing?   Combination product (Natpara) and drug or supplements [Disease and drug registry]
How many participants are being enrolled?   900
When is the trial being conducted?    - 
How long is participation in the trial?   Participation will consist of a minimum of 10 years of follow up for each participant. Management of the chronic hypoparathyroidism will be provided according to usual clinical practice by the participants\' physicians.

Key requirements

Sex   
All
Age   
All
Accepts Healthy Volunteers?   
No

Trial Details / Participation Requirements

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Trial Phase:   N/A
Trial Type:   Observational [Patient Registry]
Trial Arms/Groups or Cohorts:   
Chronic Hypoparathyroidism: 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.
Intervention:   Combination product (Natpara) and drug or supplements [Disease and drug registry]
Primary Outcome Measure(s):   
Hypoparathyroidism Laboratory Test [Time Frame: Baseline up to 10 years (follow-up)]
Clinical Laboratory Test Results [Time Frame: Baseline up to 10 years (follow-up)]
Renal Function [Time Frame: Baseline up to 10 years (follow-up)]
Incidence Rate of the Renal Events [Time Frame: Baseline up to 10 years (follow-up)]
Incidence Rate of the Soft Tissue Calcifications (site) [Time Frame: Baseline up to 10 years (follow-up)]
Incidence Rate of the Cataract [Time Frame: Baseline up to 10 years (follow-up)]
Incidence Rate of the Bone Fractures (site) [Time Frame: Baseline up to 10 years (follow-up)]
Incidence Rate of the Cardiovascular Events [Time Frame: Baseline up to 10 years (follow-up)]
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Baseline up to 10 years (follow-up)]
Secondary Outcome Measure(s):   
Health-related Quality of Life (HRQoL) [Time Frame: Baseline up to 10 years (follow-up)]
Disease-specific Patient-reported Outcome Measures [Time Frame: Baseline up to 10 years (follow-up)]
Rate of Hospitalization/Emergency Room (ER) Visits [Time Frame: Baseline up to 10 years (follow-up)]
Entry Criteria:
Inclusion Criteria: 1. Participants diagnosed with chronic hypoparathyroidism, ie, 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: 1. Participants or legally acceptable representatives unable to provide informed consent. 2. Participants using rhPTH(1-34) or used rhPTH(1-34) for more than 2 years and in the last 3 months. 3. 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. 4. History of hypoparathyroidism resulting from a known activating mutation in the CaSR gene. 5. History of hypoparathyroidism resulting from impaired responsiveness to PTH (pseudohypoparathyroidism).

Trial Locations

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University of Alabama at Birmingham

Birmingham, AL 35294, USA

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University of Arizona Medical Center

1625 N Campbell Ave, Tucson, AZ 85719, USA

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Children's Hospital Los Angeles

4650 Sunset Blvd, Los Angeles, CA 90027, USA

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Cedars-Sinai Medical Center

8631 W 3rd St, Los Angeles, CA 90048, USA

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Dr. Joselito Cabaccan

2690 S White Rd #50, San Jose, CA 95148, USA

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University of Colorado Hospital

12605 E 16th Ave, Aurora, CO 80045, USA

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Hanson Clinical Research

21216 Olean Blvd # 6, Port Charlotte, FL 33952, USA

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Thyroid & Endocrine Center of Florida

5741 Bee Ridge Rd # 500, Sarasota, FL 34233, USA

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East-West Medical Research Institute

1585 Kapiolani Blvd, Honolulu, HI 96814, USA

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Suburban Endocrinology & Diabetes

2101 S Arlington Heights Rd, Arlington Heights, IL 60005, USA

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University of Chicago Medical Center

5841 S Maryland Ave, Chicago, IL 60637, USA

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Northshore University Health System

1000 Central St #800, Evanston, IL 60201, USA

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Loyola University Medical Center

2160 S 1st Ave, Maywood, IL 60153, USA

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Indiana University Hospital

550 N University Blvd, Indianapolis, IN 46202, USA

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

1111 Medical Center Blvd, Marrero, LA 70072, USA

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Model Clinical Research

6535 Charles St # 400, Towson, MD 21204, USA

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Medstar Union Memorial Hospital

201 E University Pkwy, Baltimore, MD 21218, USA

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Massachusetts General Hospital

55 Fruit St, Boston, MA 02114, USA

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Brigham and Women's Hospital

75 Francis St, Boston, MA 02115, USA

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Brigham and Women's Hospital

75 Francis St, Boston, MA 02115, USA

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Boston Medical Center

One Boston Medical Center Pl, Boston, MA 02118, USA

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University of Minnesota

Minneapolis, MN 55455, USA

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Mayo Clinic - Rochester

200 1st St SW, Rochester, MN 55905, USA

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University of Missouri

Columbia, MO 65212, USA

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Diabetes & Endocrine Associates, P.C

7831 Chicago Ct, Omaha, NE 68114, USA

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Palm Research Center, Inc.

9280 W Sunset Rd, Las Vegas, NV 89148, USA

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Northern Nevada Endocrinology

665 Sierra Rose Dr, Reno, NV 89511, USA

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Rutgers Robert Wood Johnson Medical School

Clinical Academic Building (CAB, 125 Paterson St, New Brunswick, NJ 08901, USA

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Rutgers-Robert Wood Johnson Medical School

Clinical Academic Building (CAB, 125 Paterson St, New Brunswick, NJ 08901, USA

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Albany Med Endocrine Specialists

1365 Washington Ave # 300, Albany, NY 12206, USA

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Brokhin Medical PC

103 Quentin Rd, Brooklyn, NY 11223, USA

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Columbia University Medical Center

630 W 168th St, New York, NY 10032, USA

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Endocrine Associates of Long Island, P.C.

732 Smithtown Bypass, Smithtown, NY 11787, USA

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University Physicians Group Research Division

1460 Victory Blvd, Staten Island, NY 10301, USA

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Joslin Diabetes Center at SUNY Upstate Medical University

3229 E Genesee St, Syracuse, NY 13214, USA

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Mecklenburg Medical Group

3030 Randolph Rd STE 200, Charlotte, NC 28211, USA

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Physicians East, PA

1850 W Arlington Blvd, Greenville, NC 27834, USA

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Cleveland Clinic

9500 Euclid Ave, Cleveland, OH 44195, USA

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Ohio State University Wexner Medical Center

410 W 10th Ave, Columbus, OH 43210, USA

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Ohio Health Research Institute

3535 Olentangy River Rd, Columbus, OH 43214, USA

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Endocrinology Associates of Armstrong

2255 Canterbury Commons, Rte 422 W, Indiana, PA 15701, USA

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The Children's Hospital of Philadelphia

3401 Civic Center Blvd, Philadelphia, PA 19104, USA

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Thomas Jefferson University

901 Walnut St, Philadelphia, PA 19107, USA

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Allegheny Endocrinology Associates

420 E North Ave, Pittsburgh, PA 15212, USA

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Hallett Center for Diabetes and Endocrinology

900 Warren Ave #302, East Providence, RI 02914, USA

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University of South Carolina

Columbia, SC 29208, USA

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Texas Diabetes and Endocrinology, P.A.

6500 N Mopac Expy #200, Austin, TX 78731, USA

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Academy of Diabetes Thyroid and Endocrine

1516 Lomaland Dr, El Paso, TX 79935, USA

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Diabetes and Thyroid Center of Fort Worth, PLLC

7801 Oakmont Blvd #101, Fort Worth, TX 76132, USA

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University of Vermont

Burlington, VT 05405, USA

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University of Wisconsin

Madison, WI, USA

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Medizinische Universitat Graz

Auenbruggerpl. 2, 8036 Graz, Austria

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AKH Wien, Universitaetsklinik fuer Innere Medizin III

Währinger Gürtel 18-20, 1090 Wien, Austria

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Nova Scotia Health Authority

1276 South Park St, Halifax, NS B3H 2Y9, Canada

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McMaster University

1280 Main St W, Hamilton, ON L8S 4L8, Canada

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Aalborg Universitetshospital

Hobrovej 18-22, 9100 Aalborg, Denmark

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Aarhus Universitetshospital

Palle Juul-Jensens Blvd. 99, 8200 Aarhus, Denmark

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Nordsjaellands Hospital - Hillerod

Dyrehavevej 29, 3400 Hillerød, Denmark

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Regions Hospitalet Viborg

Heibergs Alle 5A, 8800 Viborg, Denmark

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Universitaetsklinik Aachen

Pauwelsstraße 30, 52074 Aachen, Germany

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Charite-Universitiitsmedizin Berlin (CCM)

Luisenstraße 64, 10117 Berlin, Germany

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Praxis an der Kaiserreiche

Wilhelm-Hauff-Straße 21, 12159 Berlin, Germany

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Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden

Fiedlerstraße 27, 01307 Dresden, Germany

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University Hospital Duesseldorf

Universitätsklinikum Düsseldorf, Moorenstraße 5, 40225 Düsseldorf, Germany

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Endokrinologikum Frankfurt

Stresemannallee 1/3, 60596 Frankfurt am Main, Germany

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MVZ endokrinologikum Göttingen

Von-Siebold-Straße 3, 37075 Göttingen, Germany

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Medizinische Hochschule Hannover (MHH)

Carl-Neuberg-Straße 1, 30625 Hannover, Germany

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University of Leipzig

Perlickstraße 1, 04103 Leipzig, Germany

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Universitaet Zur Luebeck

Ratzeburger Allee 160, 23562 Lübeck, Germany

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Medicover Neuroendokrinologie MVZ

Orleanspl. 3, 81667 München, Germany

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Medicover Neu-Ulm Mvz

Marienstraße 1, 89231 Neu-Ulm, Germany

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Medicover Oldenburg MVZ

Elisenstraße 12, 26122 Oldenburg, Germany

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Medicover Saarbuecken Mvz

Faktoreistraße 4, 66111 Saarbrücken, Germany

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Diakonie-Klinikum Stuttgart

Rosenbergstraße 38, 70176 Stuttgart, Germany

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Endokrinologie Zentrum Ulm

Weinbergweg 41, 89075 Ulm, Germany

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Universitaetsklinikum Wuerzburg

Josef-Schneider-Straße 2, 97080 Würzburg, Germany

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

Athanasaki 11, Athina 115 26, Greece

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General Hospital of Athens Georgios Gennimatas

Leof. Mesogeion 154, Athina 115 27, Greece

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General Hospital of Athens Alexandra

Lourou 4-2, Athina 115 28, Greece

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AHEPA University General Hospital of Thessaloniki

Kiriakidi 1, Thessaloniki 546 21, Greece

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Hippokrateion General Hospital of Thessaloniki

Konstantinoupoleos 49, Thessaloniki 546 42, Greece

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Azienda Ospedaliero-Universitaria Careggi

Largo Piero Palagi, 1, 50139 Firenze FI, Italy

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Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

Via della Commenda, 10, 20122 Milano MI, Italy

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Azienda Ospedaliera San Giovanni Addolorata

Via dell'Amba Aradam, 8, 00184 Roma RM, Italy

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

Corso Bramante, 88, 10126 Torino TO, Italy

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Haukeland University Hospital

Jonas Lies vei 65, 5021 Bergen, Norway

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Spesialistsentret Pilestredet Park

Pilestredet Park 12A, 0176 Oslo, Norway

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Hospital Del Mar

Passeig Marítim de la Barceloneta, 25, 29, 08003 Barcelona, Spain

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Hospital Universitario 12 de Octubre

Av. de Córdoba, s/n, 28041 Madrid, Spain

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Universitetssjukhuset I Linkoping

Universitetssjukhuset, 581 85 Linköping, Sweden

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Universitetssjukhuset I Orebro

Södra Grev Rosengatan, 701 85 Örebro, Sweden

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Karolinska Universitetssjukhuset Solna

Karolinska Vägen 22, 171 64 Solna, Sweden

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Akademiska Sjukhuset - Uppsala University Hospital

Dag Hammarskjölds Väg 21, 752 37 Uppsala, Sweden

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University of Hospitals of Leicester NHS Trust

Infirmary Square, Leicester LE1 5WW, UK

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Norfolk And Norwich University Hospital - Norwich Medical School

Colney Ln, Norwich NR4 7UY, UK

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Trial Protocol ID: PAR-R13-001
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