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A Registry for Patients With Chronic Hypoparathyroidism (PARADIGHM)

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ClinicalTrials.gov Identifier: NCT01922440
Recruitment Status : Recruiting
First Posted : August 14, 2013
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
Shire

Brief Summary:
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.

Condition or disease Intervention/treatment
Chronic Hypoparathyroidism Drug: Combination product (Natpara) and drug or supplements [Disease and drug registry]

Study Type : Observational [Patient Registry]
Estimated Enrollment : 900 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: PARADIGHM (Physicians Advancing Disease Knowledge in Hypoparathyroidism): A Registry for Patients With Chronic Hypoparathyroidism
Actual Study Start Date : July 1, 2013
Estimated Primary Completion Date : June 30, 2035
Estimated Study Completion Date : June 30, 2035

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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.
Drug: Combination product (Natpara) and drug or supplements [Disease and drug registry]
Interventions evaluated are combination product (Natpara) and either drug or supplements (Calcium and vitamin D)



Primary Outcome Measures :
  1. Hypoparathyroidism Laboratory Test [ Time Frame: Baseline up to 10 years (follow-up) ]
    Hypoparathyroidism laboratory tests will be evaluated as change over time for 24-hour urine calcium, serum calcium, serum magnesium, serum phosphate and 25-OH vitamin D.

  2. Clinical Laboratory Test Results [ Time Frame: Baseline up to 10 years (follow-up) ]
    Results of laboratory tests collected per standard of care.

  3. Renal Function [ Time Frame: Baseline up to 10 years (follow-up) ]
    Renal function will be evaluated as change over time for serum creatinine, estimated glomerular filtration rate (eGFR; calculated), 24-hour urine calcium and 24 hour urine protein.

  4. Incidence Rate of the Renal Events [ Time Frame: Baseline up to 10 years (follow-up) ]
    Incidence rate of the renal events will be recorded for nephrolithiasis, nephrocalcinosis, hospitalization/emergency room visits for renal events.

  5. Incidence Rate of the Soft Tissue Calcifications (site) [ Time Frame: Baseline up to 10 years (follow-up) ]
    Incidence rate of the soft tissue calcifications (site) will be recorded.

  6. Incidence Rate of the Cataract [ Time Frame: Baseline up to 10 years (follow-up) ]
    Incidence rate of the cataract will be recorded by questionnaire (present/not present).

  7. Incidence Rate of the Bone Fractures (site) [ Time Frame: Baseline up to 10 years (follow-up) ]
    Incidence rate of the bone fractures (site) will be recorded.

  8. Incidence Rate of the Cardiovascular Events [ Time Frame: Baseline up to 10 years (follow-up) ]
    Incidence rate of the cardiovascular events will be calculated for this clinical outcome. Cardiovascular events include myocardial infarction, stroke, arrhythmia.

  9. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 10 years (follow-up) ]
    An adverse event (AE) is any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in the registry, whether or not considered product-related. This includes an exacerbation of a pre - existing condition. An AE that meets one or m ore of the following criteria/outcomes is classified as SAE whether considered to be related to the pharmaceutical product or not: death, life-threatening, requires in patient hospitalization or prolongation of existing hospitalizations, a persistent or significant disability or incapacity, a congenital anomaly or birth defect and important medical events.


Secondary Outcome Measures :
  1. Health-related Quality of Life (HRQoL) [ Time Frame: Baseline up to 10 years (follow-up) ]
    Health-Related Quality of Life (HRQoL), as measured by the short-form-10 (SF-10) for pediatrics, short-form-36 (SF-36) for adults will be examined longitudinally using methods for continuous data.

  2. Disease-specific Patient-reported Outcome Measures [ Time Frame: Baseline up to 10 years (follow-up) ]
    Chronic hypoparathyroidism patient-reported outcome will be recorded as measured by the hypoparathyroidism multi-symptom diary (HPT-SD).

  3. Rate of Hospitalization/Emergency Room (ER) Visits [ Time Frame: Baseline up to 10 years (follow-up) ]
    The rate of hospitalizations and ER visits during follow-up will be summarized.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This registry is designed to enroll globally at least 900 participants with chronic hypoparathyroidism, including a minimum of 300 participants who are receiving treatment with recombinant human parathyroid hormone, rhPTH (1-84) and a minimum of 600 participants who are receiving standard of care.
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).

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: Kentress Davison    205-975-9308    kdavison@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    720-848-5146    emma.hulseberg-dwyer@ucdenver.edu   
Principal Investigator: Michael McDermott, MD         
United States, Florida
Hanson Clinical Research Recruiting
Port Charlotte, Florida, United States, 33952
Contact: Jay Cordona    941-764-9110    JAY@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: Jeanne Cercero    708-216-2058    jcerceo@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: Tilak Mallik, MD    504-349-6520    TMALLIK@DOCTORMALLIK.COM   
Contact: Baishali Mallik       BMALLIK@DOCTORMALLIK.COM   
Principal Investigator: Tilak Mallik, MD         
United States, Maryland
Model Clinical Research Recruiting
Baltimore, Maryland, United States, 21204
Contact: Karen Klein    443-524-1789    karenklein99@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: Sarah Conte    617-525-8003    sconte@partners.org   
Principal Investigator: Anil Chandraker, 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         
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    775-721-2325    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: Kim Roy    216-444-4281    KIMR@CCF.ORG   
Principal Investigator: Roy Kim, 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    928-550-3103    saminahabibi@yahoo.com   
Principal Investigator: Mushtaq Syed, MD         
The Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Jennifer Pizza    267-426-3906    HUFFORD@EMAIL.CHOP.EDU   
Principal Investigator: Michael Levine, MD         
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Joanne Alfred       JOANNE.ALFRED@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: Jane Conti-Dutko       JCONTI@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    diamondherbert@gmail.com   
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: Chelsea Padilla    817-644-3807    CPADILLA@DTC-FW.COM   
Principal Investigator: Chris Bajaj, MD         
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792
Contact: Sarah Robins    608-262-9799    ROBBINS@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

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01922440     History of Changes
Other Study ID Numbers: PAR-R13-001
First Posted: August 14, 2013    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: Yes

Keywords provided by Shire:
Chronic Hypoparathyroidism
rhPTH(1-84)
Observational study
parathyroid hormone (PTH)
Drug registry

Additional relevant MeSH terms:
Hypoparathyroidism
Parathyroid Diseases
Endocrine System Diseases