HypoparathyroidismHyPaRegNCT07857460
German Hypoparathyroidism Registry
An observational study of Hypoparathyroidism and Pseudohypoparathyroidism, run by University Hospital Augsburg at 1 site in Germany.
Trial summary
Chronic hypoparathyroidism is a rare condition in which the parathyroid glands do not make enough parathyroid hormone (PTH). PTH helps control the levels of calcium and phosphate in the blood. When there is not enough PTH, calcium levels can become too low and phosphate levels can become too high. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoparathyroidism, Pseudohypoparathyroidism
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 6 Jul 2021to 31 Dec 2037
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients within the area of Augsburg and southern Germany
Who may be able to join
- diagnosis of chronic hypo- or pseudohypoparathyroidism > 6 months or diagnosis of pseudohypoparathyroidism
- age >= 18 yrs.
- residing in Germany
- Written consent for patients capable of giving informed consent
Who cannot join
- Minors and patients with severe mental illnesses, or patients who are unable to provide written informed consent.
- Controll group
- h/o thyroidektomy with thyroid hormone replacement
- age >= 18 yrs.
- residing in Germany
- The exclusion criteria also apply to this group.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thomas Pusl, PD Dr. contact
Germany1 site, 1 recruiting
- Recruiting
University Hospital Augsburg
Augsburg, Bavaria, 86156
Christina M. Berr, Dr., +498214003938, endokrinologie@uk-augsburg.de
About this study
Official title: Registry and Biobank for Patients With Hypoparathyroidism - Data Collection on Diagnosis, Treatment, and Disease Progression
Chronic hypoparathyroidism is a rare condition in which the parathyroid glands do not make enough parathyroid hormone (PTH). PTH helps control the levels of calcium and phosphate in the blood. When there is not enough PTH, calcium levels can become too low and phosphate levels can become too high. This may cause symptoms such as tingling, muscle cramps, weakness, or other health problems.
The most common cause of chronic hypoparathyroidism is surgery in the neck area. It can happen after thyroid surgery, surgery on the parathyroid glands, or other operations in the neck.
Read more
At the moment, most patients are treated with calcium and vitamin D tablets. These treatments help control calcium levels, but they cannot fully replace the normal effects of PTH in the body. A medicine that contains a form of human PTH is available for some patients, but it is not yet the standard treatment for everyone.
This registry collects medical information and follows patients over time. Its aim is to better understand patients' symptoms, possible long-term health problems, treatments, and overall health. A group of patients who have had their thyroid removed but do not have hypoparathyroidism will also be included for comparison.
Read the detailed description
Chronic hypoparathyroidism is a rare endocrine disorder characterized by persistently reduced or absent secretion of parathyroid hormone (PTH), resulting in hypocalcemia and hyperphosphatemia with a broad spectrum of associated clinical manifestations. The most common etiology is postsurgical hypoparathyroidism, particularly following thyroid surgery, but it may also occur after parathyroid surgery or other surgical procedures involving the neck.
Hypoparathyroidism remains unique among endocrine deficiency disorders in that replacement of the deficient hormone has not yet become established as standard therapy. Although recombinant human PTH-based therapies are available for selected patient populations, conventional treatment currently relies primarily on oral calcium and vitamin D supplementation. While this approach can improve biochemical control, it does not fully reproduce the physiological actions of endogenous PTH and may therefore be associated with limitations in both short- and long-term disease management.
In Germany, systematic longitudinal data on patients with chronic hypoparathyroidism is limited. Therefore, this is a local registry for the structured documentation and follow-up of patients with chronic hypoparathyroidism and pseudohypoparathyroidism. The registry is intended to provide a structured basis for clinical, translational and basic research on chronic hypoparathyroidism. Key areas of investigation include the frequency, and severity of disease-related symptoms, diagnostic approaches and biochemical monitoring, organ specific effects, the effectiveness and limitations of conventional therapy and the emerging and novel therapeutic strategies, including PTH replacement therapies. Particular attention will also be given to long-term complications and associated comorbidities, treatment-related outcomes, quality of life and special life events like pregnancies.
Longitudinal follow-up will allow the clinical course of the disease, treatment requirements, and long-term outcomes to be assessed systematically. In addition, a cohort of patients who have undergone thyroidectomy without subsequent hypoparathyroidism will serve as a control group, allowing outcomes associated specifically with chronic hypoparathyroidism to be distinguished from those related to thyroid surgery and its underlying indications.
- Conditions
- Hypoparathyroidism, Pseudohypoparathyroidism
- Keywords
- registry, hypoparathyroidism, pseudohypoparathyroidism
- Medical subject headings
- Hypoparathyroidism, Pseudohypoparathyroidism
What is being measured
The primary outcome is the main question the study is designed to answer.
long-term comorbidities in hypoparathyroidism
compared with a controll group
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start6 Jul 2021
- Primary completion1 Feb 2036 (estimated)
- Study completion31 Dec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypoparathyroidismStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University Hospital Augsburg
- Sponsor type
- University, hospital or other
- Collaborators
- Wuerzburg University Hospital, Ascendis Pharma Endocrinology Division A/S
- Responsible party
- Principal investigator, Christina Berr. MD, University Hospital Augsburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857460
- Sponsor's protocol ID
- 21-0013
- Acronym
- HyPaReg
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data is available on reasonable request.
Publications
Siggelkow H, Peschke KA, Tsourdi E, Hofbauer LC, Berr CM, Hahner S, Lottspeich C, Schmidmaier R, Blaschke M. Switch From rhPTH1-84 to TransCon PTH With Individual Dose Adjustment in Adult Hypoparathyroidism-4-Week Results. J Endocr Soc. 2025 Jun 30;9(9):bvaf113. doi: 10.1210/jendso/bvaf113. eCollection 2025 Sep.
PubMed 40709359Berr CM, Fuss CT, Gronemeyer K, Lohr B, Pfob CH, Pusl T, Hahner S. Morning urinary calcium/creatinine ratio as a sex-specific screening tool for detecting hypercalciuria in hypoparathyroidism. Eur J Intern Med. 2026 Jun;148:106740. doi: 10.1016/j.ejim.2026.106740. Epub 2026 Feb 28.
PubMed 41763924
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry and Biobank for Patients With Hypoparathyroidism - Data Collection on Diagnosis, Treatment, and Disease Progression
- ClinicalTrials.gov ID
- NCT07857460
- Acronym / sponsor ID
- HyPaReg / 21-0013
- Conditions
- Hypoparathyroidism, Pseudohypoparathyroidism
- Keywords
- registry, hypoparathyroidism, pseudohypoparathyroidism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital AugsburgUniversity, hospital or other
- Collaborators
- Wuerzburg University Hospital, Ascendis Pharma Endocrinology Division A/S
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 1 Feb 2036 (estimated)
- Study completion
- 31 Dec 2037 (estimated)
- First posted
- 5 Oct 2026 (actual)
- 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.
Chronic hypoparathyroidism is a rare condition in which the parathyroid glands do not make enough parathyroid hormone (PTH). PTH helps control the levels of calcium and phosphate in the blood. When there is not enough PTH, calcium levels can become too low and phosphate levels can become too high. This may cause symptoms such as tingling, muscle cramps, weakness, or other health problems.
The most common cause of chronic hypoparathyroidism is surgery in the neck area. It can happen after thyroid surgery, surgery on the parathyroid glands, or other operations in the neck.
At the moment, most patients are treated with calcium and vitamin D tablets. These treatments help control calcium levels, but they cannot fully replace the normal effects of PTH in the body. A medicine that contains a form of human PTH is available for some patients, but it is not yet the standard treatment for everyone.
This registry collects medical information and follows patients over time. Its aim is to better understand patients' symptoms, possible long-term health problems, treatments, and overall health. A group of patients who have had their thyroid removed but do not have hypoparathyroidism will also be included for comparison.
Detailed description
Chronic hypoparathyroidism is a rare endocrine disorder characterized by persistently reduced or absent secretion of parathyroid hormone (PTH), resulting in hypocalcemia and hyperphosphatemia with a broad spectrum of associated clinical manifestations. The most common etiology is postsurgical hypoparathyroidism, particularly following thyroid surgery, but it may also occur after parathyroid surgery or other surgical procedures involving the neck.
Hypoparathyroidism remains unique among endocrine deficiency disorders in that replacement of the deficient hormone has not yet become established as standard therapy. Although recombinant human PTH-based therapies are available for selected patient populations, conventional treatment currently relies primarily on oral calcium and vitamin D supplementation. While this approach can improve biochemical control, it does not fully reproduce the physiological actions of endogenous PTH and may therefore be associated with limitations in both short- and long-term disease management.
In Germany, systematic longitudinal data on patients with chronic hypoparathyroidism is limited. Therefore, this is a local registry for the structured documentation and follow-up of patients with chronic hypoparathyroidism and pseudohypoparathyroidism. The registry is intended to provide a structured basis for clinical, translational and basic research on chronic hypoparathyroidism. Key areas of investigation include the frequency, and severity of disease-related symptoms, diagnostic approaches and biochemical monitoring, organ specific effects, the effectiveness and limitations of conventional therapy and the emerging and novel therapeutic strategies, including PTH replacement therapies. Particular attention will also be given to long-term complications and associated comorbidities, treatment-related outcomes, quality of life and special life events like pregnancies.
Longitudinal follow-up will allow the clinical course of the disease, treatment requirements, and long-term outcomes to be assessed systematically. In addition, a cohort of patients who have undergone thyroidectomy without subsequent hypoparathyroidism will serve as a control group, allowing outcomes associated specifically with chronic hypoparathyroidism to be distinguished from those related to thyroid surgery and its underlying indications.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients within the area of Augsburg and southern Germany
Key inclusion criteria (4 listed)
- diagnosis of chronic hypo- or pseudohypoparathyroidism > 6 months or diagnosis of pseudohypoparathyroidism
- age >= 18 yrs.
- residing in Germany
- Written consent for patients capable of giving informed consent
Key exclusion criteria (6 listed)
- Minors and patients with severe mental illnesses, or patients who are unable to provide written informed consent.
- Controll group
- h/o thyroidektomy with thyroid hormone replacement
- age >= 18 yrs.
- residing in Germany
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
long-term comorbidities in hypoparathyroidism
Time frame: 15 years
compared with a controll group
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Results publication: PubMed 40709359Siggelkow H, Peschke KA, Tsourdi E, Hofbauer LC, Berr CM, Hahner S, Lottspeich C, Schmidmaier R, Blaschke M. Switch From rhPTH1-84 to TransCon PTH With Individual Dose Adjustment in Adult Hypoparathyroidism-4-Week Results. J Endocr Soc. 2025 Jun 30;9(9):bvaf113. doi: 10.1210/jendso/bvaf113. eCollection 2025 Sep.
- Results publication: PubMed 41763924Berr CM, Fuss CT, Gronemeyer K, Lohr B, Pfob CH, Pusl T, Hahner S. Morning urinary calcium/creatinine ratio as a sex-specific screening tool for detecting hypercalciuria in hypoparathyroidism. Eur J Intern Med. 2026 Jun;148:106740. doi: 10.1016/j.ejim.2026.106740. Epub 2026 Feb 28.
- Individual participant dataSharing planned: Undecided. The data is available on reasonable request.
Related trials for Hypoparathyroidism
RecruitingPhase 3
A Study to Investigate Canvuparatide Compared With Placebo in Adult Patients With Hypoparathyroidism
Hypoparathyroidism
RecruitingPhase 3
A Phase 3 Randomized Clinical Trial to Investigate the Safety and Efficacy of Palopegteriparatide at Doses Greater Than 30 μg/Day in Adult Participants With Hypoparathyroidism
Hypoparathyroidism, Endocrine System Diseases
RecruitingObservational study
The ADVANCE (Assay Development and Validation for Pre-Natal and Obstetric Conditions) Study is the Largest U.S.-Based Prospective Study Demonstrating a Circulating Fetal Cell (CFC) Based Approach to Non-invasive Fetal Risk Assessment
Pregnant Individuals, Aneuploidy
Active, not recruitingPhase 2
Extension Study to Evaluate the Long-Term Safety and Tolerability of MBX 2109 in Patients With Hypoparathyroidism
Hypoparathyroidism
RecruitingObservational study
Postoperative Hypocalcemia After Thyroidectomy
Thyroid Nodule, Thyroid Dysfunction
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.
Thomas Pusl, PD Dr. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoparathyroidism and Pseudohypoparathyroidism, run by University Hospital Augsburg at 1 site in Germany.
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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christina M. Berr, Dr. (+498214003938, endokrinologie@uk-augsburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
long-term comorbidities in hypoparathyroidism (time frame: 15 years). 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 NCT07857460, which also lists 2 linked publications.
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 5 Oct 2026.