HypoparathyroidismPARADIGHMNCT01922440
A Registry for Participants With Chronic Hypoparathyroidism
An observational study of Hypoparathyroidism, run by Takeda at 100 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypoparathyroidism
- How many people
- 1,339 participants
- Where
- 100 sitesin 11 countries
- Study dates
- 30 Jul 2013to 30 Jun 2026
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
100 sites in 11 countries.
100 sites in 11 countries
United States54 sites
Albany Med Endocrine Specialists
Albany, New York, 12206
Suburban Endocrinology & Diabetes
Arlington Heights, Illinois, 60005
University of Colorado Hospital
Aurora, Colorado, 80045
Texas Diabetes and Endocrinology, P.A.
Austin, Texas, 78731
Model Clinical Research
Baltimore, Maryland, 21204
Medstar Union Memorial Hospital
Baltimore, Maryland, 21218
University of Alabama at Birmingham
Birmingham, Alabama, 35205
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Harvard Medical School
Boston, Massachusetts, 02115
Boston Medical Center
Boston, Massachusetts, 02118
Brokhin Medical PC
Brooklyn, New York, 11223
Mecklenburg Medical Group
Charlotte, North Carolina, 28211
University of Chicago Medical Center
Chicago, Illinois, 60637
Cleveland Clinic
Cleveland, Ohio, 44195
University of Missouri
Columbia, Missouri, 65212
University of South Carolina
Columbia, South Carolina, 29203
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Ohio Health Research Institute
Columbus, Ohio, 43214
Thyroid Endocrinology and Diabetes
Dallas, Texas, 75208
Hallett Center for Diabetes and Endocrinology
East Providence, Rhode Island, 02914
Academy of Diabetes Thyroid and Endocrine
El Paso, Texas, 79935
Northshore University Health System
Evanston, Illinois, 60201
Diabetes and Thyroid Center of Fort Worth, PLLC
Fort Worth, Texas, 76132
Physicians East, PA
Greenville, North Carolina, 27834
East-West Medical Research Institute
Honolulu, Hawaii, 96814
Endocrinology Associates of Armstrong
Indiana, Pennsylvania, 15701
Indiana University Hospital
Indianapolis, Indiana, 46202
Palm Research Center, Inc.
Las Vegas, Nevada, 89128
Children's Hospital Los Angeles
Los Angeles, California, 90027
Cedars-Sinai Medical Center
Los Angeles, California, 90048
University of Wisconsin
Madison, Wisconsin, 53792
Tilak Mallik, MD F.A.C.E., LCC
Marrero, Louisiana, 70072
Loyola University Medical Center
Maywood, Illinois, 60153
University of Minnesota
Minneapolis, Minnesota, 55455
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
Rutgers-Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
Yale University
New Haven, Connecticut, 06510
Gerald Friedman Diabetes Institute
New York, New York, 10022
Columbia University Medical Center
New York, New York, 10032
Diabetes & Endocrine Associates, Methodist Physicians Clinic Diabetes and Endocrine Specialists
Omaha, Nebraska, 68114
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, 76307
Alleghany General Hospital
Pittsburgh, Pennsylvania, 15212
Hanson Clinical Research Center
Port Charlotte, Florida, 33952
Northern Nevada Endocrinology
Reno, Nevada, 89511
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
Dr. Joselito Cabaccan
San Jose, California, 95148
Thyroid & Endocrine Center of Florida
Sarasota, Florida, 34239
Endocrine Associates of Long Island, P.C.
Smithtown, New York, 11787
University of Vermont
South Burlington, Vermont, 05403
University Physicians Group Research Division
Staten Island, New York, 10301
State University Of New York Upstate Medical University
Syracuse, New York, 13214
University of Arizona Medical Center
Tucson, Arizona, 85714
Germany17 sites
Universitaetsklinik Aachen
Aachen, 52074
Charite-Universitiitsmedizin Berlin (CCM)
Berlin, 10117
Praxis an der Kaiserreiche
Berlin, 12159
Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden
Dresden, 01307
University Hospital Duesseldorf
Düsseldorf, North Rhine-Westphalia, 40225
Endokrinologikum Frankfurt
Frankfurt, 60596
MVZ endokrinologikum Göttingen
Göttingen, 37075
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625
University of Leipzig
Leipzig, Saxony, 04103
Universitaet Zur Luebeck
Lübeck, 23538
Medicover Neuroendokrinologie MVZ
München, 81667
Medicover Neu-Ulm Mvz
Neu-Ulm, 89231
Medicover Oldenburg MVZ
Oldenburg, 26122
Medicover Saarbuecken Mvz
Saarbrücken, 66111
Diakonie-Klinikum Stuttgart
Stuttgart, Baden-Wurttemberg, 70176
Endokrinologie Zentrum Ulm
Ulm, 89075
Universitaetsklinikum Wuerzburg
Würzburg, 97080
Greece5 sites
General Hospital Of Athens - Korgialenio-Benakio E.E.S.
Athens, 11526
General Hospital of Athens Georgios Gennimatas
Athens, 11527
General Hospital of Athens Alexandra
Athens, 11528
AHEPA University General Hospital of Thessaloniki
Thessaloniki, 54636
Hippokrateion General Hospital of Thessaloniki
Thessaloniki, 54642
Denmark4 sites
Aallborg University Hospital
Aalborg, 9000
Aarhus Universitetshospital
Aarhus N, 8200
Nordsjaellands Hospital - Hillerod
Hilleroed, 3400
Regions Hospitalet Viborg
Viborg, 8800
Italy4 sites
Azienda Ospedaliero-Universitaria Careggi
Florence, FI 50139
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
Milan, MI 20122
Azienda Ospedaliera San Giovanni Addolorata
Roma, RM 00184
Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza - Ospedale Molinette
Torino, TO 10126
Sweden4 sites
Universitetssjukhuset I Linkoping
Linköping, 58185
Universitetssjukhuset I Orebro
Örebro, 70185
Karolinska Universitetssjukhuset Solna
Stockholm, 17176
Akademiska Sjukhuset - Uppsala University Hospital
Uppsala, 75185
Spain3 sites
Hospital Del Mar
Barcelona, 08003
Hospital Universitario San Cecilio
Granada, 18016
Hospital Universitario 12 de Octubre
Madrid, 28041
United Kingdom3 sites
Queen Elizabeth Hospital-Mindelsohn Way
Birmingham, England, B15
University of Hospitals of Leicester
Leicester, LE1 5WW
Norfolk And Norwich University Hospital - Norwich Medical School
Norwich, NR4 7UQ
Austria2 sites
Medizinische Universitaetsklinik Graz, Universitätsklinik Für Innere Medizin Graz
Graz, 8036
AKH Wien, Universitaetsklinik fuer Innere Medizin III
Vienna, 1090
Canada2 sites
Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 2Y9
McMaster University
Oakville, Ontario, L6J IX8
Norway2 sites
Haukeland University Hospital
Bergen, 5012
Spesialistsentret Pilestredet Park
Oslo, 0176
About this study
Official title: PARADIGHM (Physicians Advancing Disease Knowledge in Hypoparathyroidism): A Registry for Patients With Chronic Hypoparathyroidism
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.
- Conditions
- Hypoparathyroidism
- Being tested
- No intervention
- Keywords
- Chronic Hypoparathyroidism, rhPTH(1-84), Observational study, parathyroid hormone (PTH), Drug registry, rhPTH(1-34)
- Medical subject headings
- Hypoparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is a non-interventional study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention | |
| 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in 24-Hour Urine Calcium
Change from baseline in 24-hour urine calcium will be evaluated.
Measured: Baseline up to 10 years (follow-up)
Change from Baseline in Serum Calcium
Change from baseline in serum calcium will be evaluated.
Measured: Baseline up to 10 years (follow-up)
Change from Baseline in Serum Albumin
Change from baseline in serum albumin will be evaluated.
Measured: 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.
Measured: Baseline up to 10 years (follow-up)
Change from Baseline in Serum Ionized Calcium
Change from baseline in serum ionized calcium will be evaluated.
Measured: Baseline up to 10 years (follow-up)
Change from Baseline in Serum Magnesium
Change from baseline in serum magnesium will be evaluated.
Measured: Baseline up to 10 years (follow-up)
Change from Baseline in Serum Phosphate
Change from baseline in serum phosphate will be evaluated
Measured: Baseline up to 10 years (follow-up)
Change from Baseline in 25-Hydroxy (25-OH) Vitamin D results
Change from baseline in 25-OH vitamin D will be evaluated.
Measured: Baseline up to 10 years (follow-up)
Change from Baseline in Serum Creatinine
Change from baseline in serum creatinine will be evaluated.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline up to 10 years (follow-up)
Incidence Rate of the Bone Fractures (site)
Incidence rate of the bone fractures (site) will be recorded.
Measured: 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.
Measured: 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.
Measured: Baseline up to 10 years (follow-up)
Secondary outcomes (3)
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.
Measured: Baseline up to 10 years (follow-up)
Disease-specific Patient-reported Outcome Measures
Chronic hypoparathyroidism patient-reported outcome will be recorded as measured by the hypoparathyroidism multi-symptom diary (HPT-SD).
Measured: 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.
Measured: Baseline up to 10 years (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study start30 Jul 2013
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypoparathyroidismStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,339 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Takeda Development Center Americas, Inc.
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01922440
- Sponsor's protocol ID
- PAR-R13-001
- Other IDs
- EUPAS16927
- Acronym
- PARADIGHM
- Status last verified
- Jul 2026
- First submitted
- 1 Aug 2013
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
Publications
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.
PubMed 34801015
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PARADIGHM (Physicians Advancing Disease Knowledge in Hypoparathyroidism): A Registry for Patients With Chronic Hypoparathyroidism
- ClinicalTrials.gov ID
- NCT01922440
- Acronym / sponsor ID
- PARADIGHM / PAR-R13-001
- Conditions
- Hypoparathyroidism
- Keywords
- Chronic Hypoparathyroidism, rhPTH(1-84), Observational study, parathyroid hormone (PTH), Drug registry, rhPTH(1-34)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,339 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Collaborators
- Takeda Development Center Americas, Inc.
- Study start
- 30 Jul 2013 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 14 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Natpar(a) | – | Other: No interventionParticipants 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 | – | Other: No interventionParticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Participants diagnosed with chronic hypoparathyroidism, that is, hypoparathyroidism with a duration of longer than 6 months, including:
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis is a non-interventional study. | Other | Conventional Therapy, Natpar(a) |
Primary outcome
Change from Baseline in 24-Hour Urine Calcium
Time frame: Baseline up to 10 years (follow-up)
Change from baseline in 24-hour urine calcium will be evaluated.
Change from Baseline in Serum Calcium
Time frame: Baseline up to 10 years (follow-up)
Change from baseline in serum calcium will be evaluated.
Change from Baseline in Serum Albumin
Time frame: Baseline up to 10 years (follow-up)
Change from baseline in serum albumin will be evaluated.
Change from Baseline in Albumin-Corrected Total Calcium
Time frame: Baseline up to 10 years (follow-up)
Change from baseline in albumin-corrected total calcium will be evaluated.
Change from Baseline in Serum Ionized Calcium
Time frame: Baseline up to 10 years (follow-up)
Change from baseline in serum ionized calcium will be evaluated.
Change from Baseline in Serum Magnesium
Time frame: Baseline up to 10 years (follow-up)
Change from baseline in serum magnesium will be evaluated.
Change from Baseline in Serum Phosphate
Time frame: Baseline up to 10 years (follow-up)
Change from baseline in serum phosphate will be evaluated
Change from Baseline in 25-Hydroxy (25-OH) Vitamin D results
Time frame: Baseline up to 10 years (follow-up)
Change from baseline in 25-OH vitamin D will be evaluated.
Change from Baseline in Serum Creatinine
Time frame: Baseline up to 10 years (follow-up)
Change from baseline in serum creatinine will be evaluated.
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR; calculated)
Time frame: Baseline up to 10 years (follow-up)
Change from baseline in eGFR; calculated will be evaluated.
Change from Baseline in 24-Hour Urine Protein
Time frame: Baseline up to 10 years (follow-up)
Change from Baseline in 24-hour urine protein will be evaluated.
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.
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.
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).
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.
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.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 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.
3 secondary outcomes
Health-related Quality of Life (HRQoL)
Time frame: Baseline up to 10 years (follow-up)
Disease-specific Patient-reported Outcome Measures
Time frame: Baseline up to 10 years (follow-up)
Rate of Hospitalization/Emergency Room (ER) Visits
Time frame: Baseline up to 10 years (follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Derived from this study: PubMed 34801015Gittoes 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.
- To obtain more information on the study, click here/on this linkLink provided by the sponsor.
- Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
100 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoparathyroidism, run by Takeda at 100 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 100 sites in United States, Germany, Greece, Denmark, Italy and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in 24-Hour Urine Calcium (time frame: Baseline up to 10 years (follow-up)). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01922440, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.