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PARADIGHM A Natural History Registry for Patients With Chronic Hypoparathyroidism (PARADIGHM)

This study is currently recruiting participants.
Verified May 2017 by Shire
Sponsor:
ClinicalTrials.gov Identifier:
NCT01922440
First Posted: August 14, 2013
Last Update Posted: May 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Shire
  Purpose
This is a prospective, observational, natural history registry, designed to collect data on patients with chronic hypoparathyroidism. No study-defined procedures will be required, and if available, a select set of data will be collected at baseline and at least annually.

Condition Intervention
Chronic Hypoparathyroidism Other: None [Natural history registry]

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 17 Years
Official Title: PARADIGHM (Physicians Advancing Disease Knowledge in Hypoparathyroidism): A Natural History Registry for Patients With Chronic Hypoparathyroidism

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Descriptive epidemiology of chronic hypoparathyroidism from baseline up to 17 years of follow-up [ Time Frame: From baseline up to 17 years of follow-up ]
  • Change in chronic hypoparathyroidism clinical features from baseline up to 17 years of follow-up [ Time Frame: From baseline up to 17 years of follow-up ]
  • Change in chronic hypoparathyroidism treatment from baseline up to 17 years of follow-up [ Time Frame: From baseline up to 17 years of follow-up ]
  • Change in chronic hypoparathyroidism patients' health care resource use from baseline up to 17 years of follow-up [ Time Frame: From baseline up to 17 years of follow-up ]
  • Change in chronic hypoparathyroidism patients' SF-36 health survey from baseline up to 17 years of follow-up [ Time Frame: From baseline up to 17 years of follow-up ]
  • Change in chronic hypoparathyroidism patients' work productivity and activity impairment from baseline up to 17 years of follow-up [ Time Frame: From baseline up to 17 years of follow-up ]

Estimated Enrollment: 900
Study Start Date: July 1, 2013
Estimated Study Completion Date: June 1, 2032
Estimated Primary Completion Date: June 1, 2030 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Chronic Hypoparathyroidism Other: None [Natural history registry]

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients of any age or gender, with a diagnosis of chronic hypoparathyroidism before enrollment.
Criteria

Inclusion Criteria:

A patient must meet all of the following criteria to be eligible for participation in the study:

  1. Patients of any age or gender, with a diagnosis of chronic hypoparathyroidism before enrollment.

    Chronic hypoparathyroidism, defined as one of the following:

    1. PTH value unequivocally low in the presence of low serum calcium for at least 6 months prior to enrollment
    2. Post surgery (thyroid, parathyroid, neck) occurrence of hypoparathyroidism which is currently treated with calcium/calcitriol supplements to maintain a low/normal calcium (if absence of PTH level) for at least 6 months prior to enrollment
    3. Post surgery (thyroid, parathyroid, neck), both serum PTH and calcium low for at least 6 months post surgery and continues to enrollment
    4. Non-surgical hypoparathyroidism requiring calcium/calcitriol supplements to maintain a low/normal calcium (if no PTH level available) for at least 6 months prior to enrollment
  2. Signed informed consent and medical records release by the patient or a legally acceptable representative

Exclusion Criteria:

A patient who meets any of the following criteria is not eligible for participation in the study:

1. Transient hypoparathyroidism within 6 months of enrollment

  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Shire Contact clinicaltransparency@shire.com

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Tiffany Grimes    205-934-4120    tdgrimes@uab.edu   
Principal Investigator: Amy Warriner, MD         
United States, Arizona
University of Arizona Medical Center Recruiting
Tucson, Arizona, United States, 85714
Contact: Maria Ambrose    520-626-3709    maeambrose@medadmin.arizona.edu   
Principal Investigator: Craig Stump, MD         
United States, California
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Rebeca Martinez    323-361-6478    rebmartinez@chla.usc.edu   
Principal Investigator: Pisit Pitukcheewanont, MD         
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Cynthia Gudino    310-423-8321    cynthia.gudino@cshs.org   
Principal Investigator: Wendy Sacks, MD         
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Emma Hulseberg-Dwyer    720-848-2671    emma.hulseberg-dwyer@ucdenver.edu   
Principal Investigator: Michael McDermott, MD         
United States, Florida
Hanson Clinical Research Recruiting
Port Charlotte, Florida, United States, 33952
Contact: Tara Lawhorn    941-764-9110    tara@Hansoncrc.com   
Principal Investigator: Lenita Hanson, MD         
United States, Hawaii
East-West Medical Research Institute Recruiting
Honolulu, Hawaii, United States, 96814
Contact: Vutheary Hean    808-440-4466    VUTHEARY@EASTWESTRESEARCH.COM   
Principal Investigator: David Fitz-Patrick, MD         
United States, Illinois
Suburban Endocrinology & Diabetes Recruiting
Arlington Heights, Illinois, United States, 60005
Contact: Jacqueline Bueno    847-981-0560    bueno.j@endocrinetrial.com   
Principal Investigator: Mario Chan, MD         
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Luis Alcantar    773-702-1197    Lalcanta@bsd.uchicago.edu   
Principal Investigator: Tamara Vokes, MD         
Northshore University Health System Recruiting
Evanston, Illinois, United States, 60201
Contact: Sangeetha Rao    847-570-1761    srao@northshore.org   
Principal Investigator: Stuart Sprague, MD         
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Barbara Sexton    708-216-8223    bsexton@luc.edu   
Principal Investigator: Pauline Camacho         
United States, Indiana
Indiana University Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Marian Hart    317-948-8346    Marihart@iu.edu   
Principal Investigator: Munro Peacock, MD         
United States, Louisiana
Tilak Mallik, MD F.A.C.E., LCC Recruiting
Marrero, Louisiana, United States, 70072
Contact: Heather Gatewood    504-349-6520    Heatherg@doctormallik.com   
Principal Investigator: Tilak Mallik, MD         
United States, Maryland
Model Clinical Research Recruiting
Baltimore, Maryland, United States, 21204
Contact: Ranessa Labovitz    410-583-2471    ranessa1@hotmail.com   
Principal Investigator: Philip Levin, MD         
Medstar Union Memorial Hospital Recruiting
Baltimore, Maryland, United States, 21218
Contact: Ike Fleming    410-554-2486    Ike.c.fleming@medstar.net   
Principal Investigator: Paul Sack, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Emily Gentile    617-643-1694    egentile@mgh.harvard.edu   
Principal Investigator: Michael Mannstadt, MD         
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Catie Donlon    617-525-7009    cdonlon@partners.org   
Principal Investigator: Sharon Chou, MD         
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Sarah Conte    617-525-8003    sconte@partners.org   
Principal Investigator: Anil Chandraker, MD         
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Tyler Kalajian    617-638-4546    Tylerk@bu.edu   
Principal Investigator: Michael Holick, MD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Shannon Smith       srsmith@umn.edu   
Principal Investigator: Tasma Harindhanavudhi, MD         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Tamera Roberson    507-255-8621    Roberson.tamera@mayo.edu   
Principal Investigator: Bart Clarke, MD         
United States, Missouri
University of Missouri Recruiting
Columbia, Missouri, United States, 65212
Contact: Rebecca Schneider    573-882-2549    schneiderri@health.missouri.edu   
Principal Investigator: Robert Zitsch, MD         
United States, Nevada
Northern Nevada Endocrinology Recruiting
Reno, Nevada, United States, 89511
Contact: Piper Mullen       piper@pipermullen.com   
Principal Investigator: Lisa Abbott, MD         
United States, New Jersey
Rutgers Robert Wood Johnson Medical School Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Christina Varghese    732-235-7570    christinavarghese25@gmail.com   
Principal Investigator: Ian Marshall, MD         
Rutgers Robert Wood Johnson Medical School Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Juman Takeddin       jt725@rwjms.rutgers.edu   
Principal Investigator: Sara Lubitz, MD         
United States, New York
Brokhin Medical PC Recruiting
Brooklyn, New York, United States, 11223
Contact: Catherine Sekansky    347-462-9292    csekansky@yahoo.com   
Principal Investigator: Matvey Brokhin, MD         
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Wendy Fan    212-305-7364    wf2159@cumc.columbia.edu   
Principal Investigator: John Bilezikian, MD         
Endocrine Associates of Long Island, P.C. Recruiting
Smithtown, New York, United States, 11787
Contact: Lisa Iannuzzi    631-265-5501    Islandendo@aol.com   
Principal Investigator: Michael Shanik, MD         
University Physicians Group Research Division Recruiting
Staten Island, New York, United States, 10301
Contact: Bridget Recker    718-442-0300    research@upg.com   
Principal Investigator: Jeffrey Rothman, MD         
Joslin Diabetes Center at SUNY Upstate Medical University Recruiting
Syracuse, New York, United States, 13214
Contact: Jane Bulger    315-464-9008    BulgerJ@upstate.edu   
Principal Investigator: Ruban Dhaliwal, MD         
United States, North Carolina
Mecklenburg Medical Group Recruiting
Charlotte, North Carolina, United States, 28211
Contact: Dorothy Owens    704-302-8218    Dorothy.Owens@Carolinashealthcare.org   
Principal Investigator: Gary Rolband, MD         
Physicians East, PA Recruiting
Greenville, North Carolina, United States, 27834
Contact: Kristie Daly-Barnes    252-413-6232    kbarnes@physicianseast.com   
Principal Investigator: Mark Warren, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Debbie Latham    216-445-4944    LATHAMD2@CCF.ORG   
Principal Investigator: Laurie Tsilianidis, MD         
Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43203
Contact: Amber Anaya    614-688-6257    amber.anaya@osumc.edu   
Principal Investigator: Steven Ing, MD         
Ohio Health Research Institute Recruiting
Columbus, Ohio, United States, 43214
Contact: Katy Groezinger    614-566-1255    KATY.GROEZINGER@OHIOHEALTH.COM   
Principal Investigator: Michelle Kovalaske, MD         
United States, Pennsylvania
Endocrinology Associates of Armstrong Recruiting
Indiana, Pennsylvania, United States, 15701
Contact: Samina Habibi    724-463-1048    saminahabibi@yahoo.com   
Principal Investigator: Mushtaq Syed, MD         
The Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Bernadette Montgomery    267-426-7482    montgomerb@email.chop.edu   
Principal Investigator: Michael Levine, MD         
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Marsha Simmons    215-955-8405    marsha.simmons@jefferson.edu   
Principal Investigator: Intekhab Ahmed, MD         
United States, Rhode Island
Hallett Center for Diabetes and Endocrinology Recruiting
East Providence, Rhode Island, United States, 02914
Contact: Ricardo Correa    401-444-3420    ricardo.correa@lifespan.org   
Principal Investigator: Geetha Gopalakrishnan, MD         
United States, South Carolina
University of South Carolina Recruiting
Columbia, South Carolina, United States, 29203
Contact: Diamond Herbert    803-545-5430    diamond.herbert@uscmed.sc.edu   
Principal Investigator: Ali Rizvi, MD         
United States, Texas
Texas Diabetes and Endocrinology, P.A. Recruiting
Austin, Texas, United States, 78731
Contact: LILY AHN    512-334-3505    LAHN@TEXASDIABETES.COM   
Principal Investigator: Valerie Espinosa, MD         
Diabetes and Thyroid Center of Fort Worth, PLLC Recruiting
Fort Worth, Texas, United States, 76132
Contact: Candace Miller    817-644-3807    cmiller@dtc-fw.com   
Principal Investigator: Chris Bajaj, MD         
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792
Contact: Jagpreet Sekhon    608-262-0825    sekhon@surgery.wisc.edu   
Principal Investigator: Becky Sippel, MD         
Canada, Nova Scotia
Nova Scotia Health Authority Recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Contact: Glenda McCarthy       glenda.mccarthy@nshealth.ca   
Principal Investigator: Stephanie Kaiser         
Canada, Ontario
McMaster University Recruiting
Oakville, Ontario, Canada, L6J IX8
Contact: Namrah Siraj       NAMRAH@BONERESEARCH.CA   
Principal Investigator: Aliya Khan, MD         
Denmark
Aalborg University Hospital Recruiting
Aalborg, Denmark, 9100
Contact: Peter Vestergaard    +45-99403791    p-vest@post4.tele.dk   
Principal Investigator: Peter Vestergaard         
Aarhus University Hospital Recruiting
Aarhus-C, Denmark, DK8000
Contact: Lars Rejnmark    45-78467178    larsnien@rm.dk   
Principal Investigator: Lars Rejnmark         
Regions Hospitalet Viborg Recruiting
Viborg, Denmark, 8800
Contact: Torben Østergard    45-78447599    TORBEN.OESTERGAARD@MIDT.RM.DK   
Principal Investigator: Torben Østergard         
Sponsors and Collaborators
Shire
Investigators
Study Director: Shire Study Physician Shire
  More Information

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01922440     History of Changes
Other Study ID Numbers: PAR-R13-001
First Submitted: August 1, 2013
First Posted: August 14, 2013
Last Update Posted: May 25, 2017
Last Verified: May 2017

Keywords provided by Shire:
Registry
Chronic Hypoparathyroidism
Observational study
Natural History
Chronic HPTH

Additional relevant MeSH terms:
Hypoparathyroidism
Parathyroid Diseases
Endocrine System Diseases