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| ID | Type | Description | Link |
|---|---|---|---|
| EUPAS16927 | Other Identifier | ENCePP EU PAS |
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| Name | Class |
|---|---|
| Takeda Development Center Americas, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Natpar(a) | 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 | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | This is a non-interventional study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in 24-Hour Urine Calcium | Change from baseline in 24-hour urine calcium will be evaluated. | Baseline up to 10 years (follow-up) |
| Change from Baseline in Serum Calcium | Change from baseline in serum calcium will be evaluated. | Baseline up to 10 years (follow-up) |
| Change from Baseline in Serum Albumin | Change from baseline in serum albumin will be evaluated. | Baseline up to 10 years (follow-up) |
| Change from Baseline in Albumin-Corrected Total Calcium | Change from baseline in albumin-corrected total calcium will be evaluated. | Baseline up to 10 years (follow-up) |
| Change from Baseline in Serum Ionized Calcium | Change from baseline in serum ionized calcium will be evaluated. | Baseline up to 10 years (follow-up) |
| Change from Baseline in Serum Magnesium | Change from baseline in serum magnesium will be evaluated. | Baseline up to 10 years (follow-up) |
| Change from Baseline in Serum Phosphate | Change from baseline in serum phosphate will be evaluated | Baseline up to 10 years (follow-up) |
| Change from Baseline in 25-Hydroxy (25-OH) Vitamin D results |
| Measure | Description | Time Frame |
|---|---|---|
| Health-related Quality of Life (HRQoL) | 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. | Baseline up to 10 years (follow-up) |
| Disease-specific Patient-reported Outcome Measures |
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Inclusion Criteria:
Participants diagnosed with chronic hypoparathyroidism, that is, hypoparathyroidism with a duration of longer than 6 months, including:
Exclusion Criteria:
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.
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This global registry is expected to enroll a minimum of 900 participants, of whom at least 300 will be participants treated with rhPTH(1-84) and at least 600 will be participants receiving standard of care. Protocol amendment 9 revised the sample size: up to 164 additional participants treated with rhPTH(1-84) (ie, up to a total of 464 participants in that cohort) will be enrolled as needed to ensure the availability of 104 rhPTH(1-84)-treated participants with a full 10 years of follow-up.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35205 | United States | ||
| University of Arizona Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34801015 | Derived | Gittoes N, Rejnmark L, Ing SW, Brandi ML, Bjornsdottir S, Hahner S, Hofbauer LC, Houillier P, Khan AA, Levine MA, Mannstadt M, Shoback DM, Vokes TJ, Zhang P, Marelli C, Germak J, Clarke BL. The PARADIGHM (physicians advancing disease knowledge in hypoparathyroidism) registry for patients with chronic hypoparathyroidism: study protocol and interim baseline patient characteristics. BMC Endocr Disord. 2021 Nov 20;21(1):232. doi: 10.1186/s12902-021-00888-2. |
| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
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Change from baseline in 25-OH vitamin D will be evaluated. |
| Baseline up to 10 years (follow-up) |
| Change from Baseline in Serum Creatinine | Change from baseline in serum creatinine will be evaluated. | Baseline up to 10 years (follow-up) |
| Change from Baseline in Estimated Glomerular Filtration Rate (eGFR; calculated) | Change from baseline in eGFR; calculated will be evaluated. | Baseline up to 10 years (follow-up) |
| Change from Baseline in 24-Hour Urine Protein | Change from Baseline in 24-hour urine protein will be evaluated. | Baseline up to 10 years (follow-up) |
| Incidence Rate of the Renal Events | Incidence rate of the renal events will be recorded for nephrolithiasis, nephrocalcinosis, hospitalization/emergency room visits for renal events. | Baseline up to 10 years (follow-up) |
| Incidence Rate of the Soft Tissue Calcifications (site) | Incidence rate of the soft tissue calcifications (site) will be recorded. | Baseline up to 10 years (follow-up) |
| Incidence Rate of the Cataract | Incidence rate of the cataract will be recorded by questionnaire (present/not present). | Baseline up to 10 years (follow-up) |
| Incidence Rate of the Bone Fractures (site) | Incidence rate of the bone fractures (site) will be recorded. | Baseline up to 10 years (follow-up) |
| Incidence Rate of the Cardiovascular Events | Incidence rate of the cardiovascular events will be calculated for this clinical outcome. Cardiovascular events include myocardial infarction, stroke, arrhythmia. | Baseline up to 10 years (follow-up) |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | 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). |
| Baseline up to 10 years (follow-up) |
| Rate of Hospitalization/Emergency Room (ER) Visits | The rate of hospitalizations and ER visits during follow-up will be summarized. | Baseline up to 10 years (follow-up) |
| Tucson |
| Arizona |
| 85714 |
| United States |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Dr. Joselito Cabaccan | San Jose | California | 95148 | United States |
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
| Yale University | New Haven | Connecticut | 06510 | United States |
| Hanson Clinical Research Center | Port Charlotte | Florida | 33952 | United States |
| Thyroid & Endocrine Center of Florida | Sarasota | Florida | 34239 | United States |
| East-West Medical Research Institute | Honolulu | Hawaii | 96814 | United States |
| Suburban Endocrinology & Diabetes | Arlington Heights | Illinois | 60005 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Northshore University Health System | Evanston | Illinois | 60201 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Indiana University Hospital | Indianapolis | Indiana | 46202 | United States |
| Tilak Mallik, MD F.A.C.E., LCC | Marrero | Louisiana | 70072 | United States |
| Model Clinical Research | Baltimore | Maryland | 21204 | United States |
| Medstar Union Memorial Hospital | Baltimore | Maryland | 21218 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Harvard Medical School | Boston | Massachusetts | 02115 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | United States |
| University of Missouri | Columbia | Missouri | 65212 | United States |
| Diabetes & Endocrine Associates, Methodist Physicians Clinic Diabetes and Endocrine Specialists | Omaha | Nebraska | 68114 | United States |
| Palm Research Center, Inc. | Las Vegas | Nevada | 89128 | United States |
| Northern Nevada Endocrinology | Reno | Nevada | 89511 | United States |
| Rutgers Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08901 | United States |
| Rutgers-Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08901 | United States |
| Albany Med Endocrine Specialists | Albany | New York | 12206 | United States |
| Brokhin Medical PC | Brooklyn | New York | 11223 | United States |
| Gerald Friedman Diabetes Institute | New York | New York | 10022 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Endocrine Associates of Long Island, P.C. | Smithtown | New York | 11787 | United States |
| University Physicians Group Research Division | Staten Island | New York | 10301 | United States |
| State University Of New York Upstate Medical University | Syracuse | New York | 13214 | United States |
| Mecklenburg Medical Group | Charlotte | North Carolina | 28211 | United States |
| Physicians East, PA | Greenville | North Carolina | 27834 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| Ohio Health Research Institute | Columbus | Ohio | 43214 | United States |
| Endocrinology Associates of Armstrong | Indiana | Pennsylvania | 15701 | United States |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 76307 | United States |
| Alleghany General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| Hallett Center for Diabetes and Endocrinology | East Providence | Rhode Island | 02914 | United States |
| University of South Carolina | Columbia | South Carolina | 29203 | United States |
| Texas Diabetes and Endocrinology, P.A. | Austin | Texas | 78731 | United States |
| Thyroid Endocrinology and Diabetes | Dallas | Texas | 75208 | United States |
| Academy of Diabetes Thyroid and Endocrine | El Paso | Texas | 79935 | United States |
| Diabetes and Thyroid Center of Fort Worth, PLLC | Fort Worth | Texas | 76132 | United States |
| University of Vermont | South Burlington | Vermont | 05403 | United States |
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
| Medizinische Universitaetsklinik Graz, Universitätsklinik Für Innere Medizin Graz | Graz | 8036 | Austria |
| AKH Wien, Universitaetsklinik fuer Innere Medizin III | Vienna | 1090 | Austria |
| Nova Scotia Health Authority | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| McMaster University | Oakville | Ontario | L6J IX8 | Canada |
| Aallborg University Hospital | Aalborg | 9000 | Denmark |
| Aarhus Universitetshospital | Aarhus N | 8200 | Denmark |
| Nordsjaellands Hospital - Hillerod | Hilleroed | 3400 | Denmark |
| Regions Hospitalet Viborg | Viborg | 8800 | Denmark |
| Diakonie-Klinikum Stuttgart | Stuttgart | Baden-Wurttemberg | 70176 | Germany |
| Medizinische Hochschule Hannover | Hanover | Lower Saxony | 30625 | Germany |
| University Hospital Duesseldorf | Düsseldorf | North Rhine-Westphalia | 40225 | Germany |
| University of Leipzig | Leipzig | Saxony | 04103 | Germany |
| Universitaetsklinik Aachen | Aachen | 52074 | Germany |
| Charite-Universitiitsmedizin Berlin (CCM) | Berlin | 10117 | Germany |
| Praxis an der Kaiserreiche | Berlin | 12159 | Germany |
| Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden | Dresden | 01307 | Germany |
| Endokrinologikum Frankfurt | Frankfurt | 60596 | Germany |
| MVZ endokrinologikum Göttingen | Göttingen | 37075 | Germany |
| Universitaet Zur Luebeck | Lübeck | 23538 | Germany |
| Medicover Neuroendokrinologie MVZ | München | 81667 | Germany |
| Medicover Neu-Ulm Mvz | Neu-Ulm | 89231 | Germany |
| Medicover Oldenburg MVZ | Oldenburg | 26122 | Germany |
| Medicover Saarbuecken Mvz | Saarbrücken | 66111 | Germany |
| Endokrinologie Zentrum Ulm | Ulm | 89075 | Germany |
| Universitaetsklinikum Wuerzburg | Würzburg | 97080 | Germany |
| General Hospital Of Athens - Korgialenio-Benakio E.E.S. | Athens | 11526 | Greece |
| General Hospital of Athens Georgios Gennimatas | Athens | 11527 | Greece |
| General Hospital of Athens Alexandra | Athens | 11528 | Greece |
| AHEPA University General Hospital of Thessaloniki | Thessaloniki | 54636 | Greece |
| Hippokrateion General Hospital of Thessaloniki | Thessaloniki | 54642 | Greece |
| Azienda Ospedaliero-Universitaria Careggi | Florence | FI 50139 | Italy |
| Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico | Milan | MI 20122 | Italy |
| Azienda Ospedaliera San Giovanni Addolorata | Roma | RM 00184 | Italy |
| Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza - Ospedale Molinette | Torino | TO 10126 | Italy |
| Haukeland University Hospital | Bergen | 5012 | Norway |
| Spesialistsentret Pilestredet Park | Oslo | 0176 | Norway |
| Hospital Del Mar | Barcelona | 08003 | Spain |
| Hospital Universitario San Cecilio | Granada | 18016 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Universitetssjukhuset I Linkoping | Linköping | 58185 | Sweden |
| Universitetssjukhuset I Orebro | Örebro | 70185 | Sweden |
| Karolinska Universitetssjukhuset Solna | Stockholm | 17176 | Sweden |
| Akademiska Sjukhuset - Uppsala University Hospital | Uppsala | 75185 | Sweden |
| Queen Elizabeth Hospital-Mindelsohn Way | Birmingham | England | B15 | United Kingdom |
| University of Hospitals of Leicester | Leicester | LE1 5WW | United Kingdom |
| Norfolk And Norwich University Hospital - Norwich Medical School | Norwich | NR4 7UQ | United Kingdom |
| ID | Term |
|---|---|
| D007011 | Hypoparathyroidism |
| ID | Term |
|---|---|
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
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