Trial record 1 of 61 for:    hypoparathyroidism
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PARADIGHM A Natural History Registry for Patients With Chronic Hypoparathyroidism

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by NPS Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
NPS Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01922440
First received: August 1, 2013
Last updated: October 8, 2014
Last verified: October 2014
  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: 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 NPS Pharmaceuticals:

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

  Eligibility

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01922440

Contacts
Contact: Clinical Operations 908-450-5300 info@hypoparathyroidism.com

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Kentress Davison    205-975-9308    kdavison@uab.edu   
Principal Investigator: Amy Warriner, MD         
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Bev McLaughlin    303-724-1026    Bev.Mclaughlin@UCDenver.edu   
Principal Investigator: Michael McDermott, MD         
United States, Illinois
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: Shonny Fettman    847-570-1761    SFettman@Northshore.org   
Principal Investigator: Stuart Sprague, MD         
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, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Christine Dyer-Ward    617-732-8553    CDyer@partners.org   
Principal Investigator: Anil Chandraker, MD         
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Elizabeth Monis    617-726-3966    emonis@partners.org   
Principal Investigator: Michael Mannstadt, MD         
United States, Minnesota
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, New Jersey
Rutgers Robert Wood Johnson Medical School Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Lissette Cespedes       Lissette.cespedes@gmail.com   
Principal Investigator: Sara Lubitz, MD         
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Laura Anderson    212-305-0573    LBA2131@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: Arnold Moses, 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
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         
United States, Pennsylvania
Endocrinology Associates of Armstrong Recruiting
Indiana, Pennsylvania, United States, 15701
Contact: Samina Habibi    724-463-1048      
Principal Investigator: Mushtaq Syed, MD         
The Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: MaryJane Benton    215-590-4269    Benton@email.chop.edu   
Principal Investigator: Michael Levine, MD         
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Amanda Salvatore       Amanda.Salvatore@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: Betsy Parrott    401-444-2091    EParrott@Lifespan.org   
Principal Investigator: Geetha Gopalakrishnan, MD         
United States, South Carolina
University of South Carolina Recruiting
Columbia, South Carolina, United States, 29203
Contact: Melanie Whitmire    803-545-5430    Melanie.Whitmire@USCMED.SC.edu   
Principal Investigator: Ali Rizvi, MD         
Sponsors and Collaborators
NPS Pharmaceuticals
Investigators
Study Director: Steven Bowlin, DO, MPH, PhD NPS Pharmaceuticals
  More Information

No publications provided

Responsible Party: NPS Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01922440     History of Changes
Other Study ID Numbers: PAR-R13-001
Study First Received: August 1, 2013
Last Updated: October 8, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Hypoparathyroidism
Endocrine System Diseases
Parathyroid Diseases

ClinicalTrials.gov processed this record on October 23, 2014