A Registry for Participants With Chronic Hypoparathyroidism
- Conditions
- Hypoparathyroidism
- Interventions
- Other: No intervention
- Registration Number
- NCT01922440
- Lead Sponsor
- Takeda
- Brief Summary
The main aim of this study is to find out the long-term safety and effectiveness profile of recombinant human parathyroid hormone (1-84) (rhPTH\[1-84\]) treatment in participants with chronic hypoparathyroidism under conditions of routine clinical practice.
Participants will be treated according to their clinic's standard practice determined by the treating doctors. Each participant will fill out a study questionnaire during a routine doctor visit.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1339
-
Participants diagnosed with chronic hypoparathyroidism, that is, hypoparathyroidism with a duration of longer than 6 months, including:
- 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.
- 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.
- Participants or legally acceptable representatives unable to provide informed consent.
- Participants using rhPTH(1-34) or who used rhPTH(1-34) for more than 2 years are excluded. Participants who had been treated with rhPTH(1-34) within 3 months of enrollment are also excluded as are participants currently using rhPTH(1-34).
FOR US SITES ONLY: Participants treated with rhPTH(1-84) prior to the US recall may use rhPTH(1-34) only while rhPTH(1-84) is unavailable due to the recall.
- 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.
- History of hypoparathyroidism resulting from impaired responsiveness to PTH (pseudohypoparathyroidism).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Natpar(a) No intervention Participants receiving parathyroid hormone (rhPTH(1-84) (Natpar\[a\]) for treatment of chronic hypoparathyroidism as per standard clinical practice will be enrolled and evaluated during the study period. Conventional Therapy No intervention Participants receiving conventional therapy/standard of care (including calcium supplements, active vitamin D, vitamin D) for treatment of chronic hypoparathyroidism as per standard clinical practice will be enrolled and evaluated during the study period.
- Primary Outcome Measures
Name Time Method Change from Baseline in Serum Magnesium Baseline up to 10 years (follow-up) Change from baseline in serum magnesium will be evaluated.
Change from Baseline in 25-Hydroxy (25-OH) Vitamin D results Baseline up to 10 years (follow-up) Change from baseline in 25-OH vitamin D will be evaluated.
Change from Baseline in Serum Creatinine Baseline up to 10 years (follow-up) Change from baseline in serum creatinine will be evaluated.
Incidence Rate of the Renal Events 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.
Change from Baseline in 24-Hour Urine Calcium Baseline up to 10 years (follow-up) Change from baseline in 24-hour urine calcium will be evaluated.
Change from Baseline in Serum Albumin Baseline up to 10 years (follow-up) Change from baseline in serum albumin will be evaluated.
Change from Baseline in Serum Phosphate Baseline up to 10 years (follow-up) Change from baseline in serum phosphate will be evaluated
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR; calculated) Baseline up to 10 years (follow-up) Change from baseline in eGFR; calculated will be evaluated.
Incidence Rate of the Bone Fractures (site) Baseline up to 10 years (follow-up) Incidence rate of the bone fractures (site) will be recorded.
Change from Baseline in Serum Calcium Baseline up to 10 years (follow-up) Change from baseline in serum calcium will be evaluated.
Change from Baseline in Serum Ionized Calcium Baseline up to 10 years (follow-up) Change from baseline in serum ionized calcium will be evaluated.
Change from Baseline in 24-Hour Urine Protein Baseline up to 10 years (follow-up) Change from Baseline in 24-hour urine protein will be evaluated.
Change from Baseline in Albumin-Corrected Total Calcium Baseline up to 10 years (follow-up) Change from baseline in albumin-corrected total calcium will be evaluated.
Incidence Rate of the Soft Tissue Calcifications (site) Baseline up to 10 years (follow-up) Incidence rate of the soft tissue calcifications (site) will be recorded.
Incidence Rate of the Cardiovascular Events 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.
Incidence Rate of the Cataract Baseline up to 10 years (follow-up) Incidence rate of the cataract will be recorded by questionnaire (present/not present).
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Baseline up to 10 years (follow-up) An AE is any untoward medical occurrence in a participant administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, a new disease or worsening in severity or frequency of a concomitant disease, temporally associated with the use of a medicinal product, whether or not the event is considered causally related to the use of the product. An SAE is any untoward medical occurrence (whether considered to be related to study product or not) that at any dose results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality or birth defect, an important medical event.
- Secondary Outcome Measures
Name Time Method Health-related Quality of Life (HRQoL) 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.
Rate of Hospitalization/Emergency Room (ER) Visits Baseline up to 10 years (follow-up) The rate of hospitalizations and ER visits during follow-up will be summarized.
Disease-specific Patient-reported Outcome Measures 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).
Trial Locations
- Locations (100)
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Ohio Health Research Institute
🇺🇸Columbus, Ohio, United States
Alleghany General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
University of South Carolina
🇺🇸Columbia, South Carolina, United States
Thyroid & Endocrine Center of Florida
🇺🇸Sarasota, Florida, United States
Medstar Union Memorial Hospital
🇺🇸Baltimore, Maryland, United States
The Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Diabetes and Thyroid Center of Fort Worth, PLLC
🇺🇸Fort Worth, Texas, United States
Aarhus Universitetshospital
🇩🇰Aarhus N, Denmark
Regions Hospitalet Viborg
🇩🇰Viborg, Denmark
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Harvard Medical School
🇺🇸Boston, Massachusetts, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Indiana University Hospital
🇺🇸Indianapolis, Indiana, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Palm Research Center, Inc.
🇺🇸Las Vegas, Nevada, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Mayo Clinic - Rochester
🇺🇸Rochester, Minnesota, United States
University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
Diabetes & Endocrine Associates, Methodist Physicians Clinic Diabetes and Endocrine Specialists
🇺🇸Omaha, Nebraska, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
University of Arizona Medical Center
🇺🇸Tucson, Arizona, United States
Dr. Joselito Cabaccan
🇺🇸San Jose, California, United States
Hanson Clinical Research Center
🇺🇸Port Charlotte, Florida, United States
Suburban Endocrinology & Diabetes
🇺🇸Arlington Heights, Illinois, United States
Tilak Mallik, MD F.A.C.E., LCC
🇺🇸Marrero, Louisiana, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Northshore University Health System
🇺🇸Evanston, Illinois, United States
Northern Nevada Endocrinology
🇺🇸Reno, Nevada, United States
Rutgers Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
Albany Med Endocrine Specialists
🇺🇸Albany, New York, United States
Brokhin Medical PC
🇺🇸Brooklyn, New York, United States
Gerald Friedman Diabetes Institute
🇺🇸New York, New York, United States
University Physicians Group Research Division
🇺🇸Staten Island, New York, United States
Endocrine Associates of Long Island, P.C.
🇺🇸Smithtown, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
State University Of New York Upstate Medical University
🇺🇸Syracuse, New York, United States
Physicians East, PA
🇺🇸Greenville, North Carolina, United States
Mecklenburg Medical Group
🇺🇸Charlotte, North Carolina, United States
Endocrinology Associates of Armstrong
🇺🇸Indiana, Pennsylvania, United States
Texas Diabetes and Endocrinology, P.A.
🇺🇸Austin, Texas, United States
Thyroid Endocrinology and Diabetes
🇺🇸Dallas, Texas, United States
Hallett Center for Diabetes and Endocrinology
🇺🇸East Providence, Rhode Island, United States
Academy of Diabetes Thyroid and Endocrine
🇺🇸El Paso, Texas, United States
Medizinische Universitaetsklinik Graz, Universitätsklinik Für Innere Medizin Graz
🇦🇹Graz, Austria
AKH Wien, Universitaetsklinik fuer Innere Medizin III
🇦🇹Wien, Austria
Aallborg University Hospital
🇩🇰Aalborg, Denmark
University of Vermont
🇺🇸South Burlington, Vermont, United States
McMaster University
🇨🇦Oakville, Ontario, Canada
Nordsjaellands Hospital - Hillerod
🇩🇰Hilleroed, Denmark
Diakonie-Klinikum Stuttgart
🇩🇪Stuttgart, Baden-Wuerttemberg, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Lower Saxony, Germany
University Hospital Duesseldorf
🇩🇪Dusseldorf, Nordrhein-Westfalen, Germany
University of Leipzig
🇩🇪Leipzig, Sachsen, Germany
Universitaetsklinik Aachen
🇩🇪Aachen, Germany
Charite-Universitiitsmedizin Berlin (CCM)
🇩🇪Berlin, Germany
Praxis an der Kaiserreiche
🇩🇪Berlin, Germany
Endokrinologikum Frankfurt
🇩🇪Frankfurt, Germany
MVZ endokrinologikum Göttingen
🇩🇪Göttingen, Germany
Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden
🇩🇪Dresden, Germany
Universitaet Zur Luebeck
🇩🇪Luebeck, Germany
Medicover Oldenburg MVZ
🇩🇪Oldenburg, Germany
Medicover Neuroendokrinologie MVZ
🇩🇪Muenchen, Germany
Medicover Neu-Ulm Mvz
🇩🇪Neu-Ulm, Germany
General Hospital Of Athens - Korgialenio-Benakio E.E.S.
🇬🇷Athens, Greece
Endokrinologie Zentrum Ulm
🇩🇪Ulm, Germany
General Hospital of Athens Alexandra
🇬🇷Athens, Greece
Medicover Saarbuecken Mvz
🇩🇪Saarbruecken, Germany
Universitaetsklinikum Wuerzburg
🇩🇪Wuerzburg, Germany
General Hospital of Athens Georgios Gennimatas
🇬🇷Athens, Greece
Hippokrateion General Hospital of Thessaloniki
🇬🇷Thessaloniki, Greece
AHEPA University General Hospital of Thessaloniki
🇬🇷Thessaloniki, Greece
Azienda Ospedaliero-Universitaria Careggi
🇮🇹Firenze, Italy
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
🇮🇹Milano, Italy
Azienda Ospedaliera San Giovanni Addolorata
🇮🇹Roma, Italy
Haukeland University Hospital
🇳🇴Bergen, Norway
Spesialistsentret Pilestredet Park
🇳🇴Oslo, Norway
Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza - Ospedale Molinette
🇮🇹Torino, Italy
Hospital Del Mar
🇪🇸Barcelona, Spain
Hospital Universitario San Cecilio
🇪🇸Granada, Spain
Universitetssjukhuset I Linkoping
🇸🇪Linkoping, Sweden
Universitetssjukhuset I Orebro
🇸🇪Orebro, Sweden
Akademiska Sjukhuset - Uppsala University Hospital
🇸🇪Uppsala, Sweden
Karolinska Universitetssjukhuset Solna
🇸🇪Stockholm, Sweden
Queen Elizabeth Hospital-Mindelsohn Way
🇬🇧Birmingham, England, United Kingdom
Norfolk And Norwich University Hospital - Norwich Medical School
🇬🇧Norwich, United Kingdom
University of Hospitals of Leicester
🇬🇧Leicester, United Kingdom
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
University of Missouri
🇺🇸Columbia, Missouri, United States
Nova Scotia Health Authority
🇨🇦Halifax, Nova Scotia, Canada
Yale University
🇺🇸New Haven, Connecticut, United States
Rutgers-Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
Model Clinical Research
🇺🇸Baltimore, Maryland, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
East-West Medical Research Institute
🇺🇸Honolulu, Hawaii, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States