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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Shire
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01922440
First received: August 1, 2013
Last updated: November 30, 2016
Last verified: November 2016
  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 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 ] [ 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 Other: None [Natural history registry]

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
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: Shire Contact clinicaltransparency@shire.com

  Show 46 Study Locations
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 
Study First Received: August 1, 2013
Last Updated: November 30, 2016
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Hypoparathyroidism
Parathyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on December 08, 2016