Trial record 1 of 45 for:    "Hypoparathyroidism"
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PARADIGHM A Natural History Registry for Patients With Chronic Hypoparathyroidism

This study is currently recruiting participants.
Verified April 2014 by NPS Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
NPS Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01922440
First received: August 1, 2013
Last updated: April 7, 2014
Last verified: April 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01922440

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

Locations
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         
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
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 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
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       Saminahabibi@yahoo.com   
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         
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: April 7, 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
Parathyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 20, 2014