HypoparathyroidismNCT03437174
Burden of Illness in Hypoparathyroidism
An observational study of Hypoparathyroidism, run by University of Wuerzburg at 5 sites in Germany.
Trial summary
Long-term conventional treatment of chronic hypoparathyroidism does not fully restore calcium homeostasis leading to increased morbidity, emergency events and reduced subjective health status. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoparathyroidism
- How many people
- 205 participants
- Where
- 5 sitesGermany
- Study dates
- 1 Aug 2015to 1 Jan 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with chronic hypo- and pseudohypoparathyroidism
Who may be able to join
- chronic hypoparathyroidism (>12 months) under established therapy
- chronic pseudohypoparathyroidism (>12 months) under established therapy
- written informed consent
Who cannot join
- age <18 years
- no detailed documentation of hypo- or pseudohypoparathyroidism
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Endokrinologie in Charlottenburg
Berlin, D-10627
Charite Berlin
Berlin
Ludwig-Maximilians-Universität
Munich, 81377
University Hospital Rostock
Rostock, 18057
Dept. of Endocrinology and Diabetology, Dept. of Medicine I, University Hospital Wuerzburg
Würzburg, 97080
About this study
Official title: Burden of Illness and Disease Associated Emergencies in Chronic Hypoparathyroidism
Long-term conventional treatment of chronic hypoparathyroidism does not fully restore calcium homeostasis leading to increased morbidity, emergency events and reduced subjective health status. To further investigate general morbidity, hypocalcemic events, subjective and daily life performance in patients with chronic hypoparathyroidism a disease specific questionnaire, as well as the SF-36 are handed out.
Read the detailed description
Design:
In a cross-sectional trial the subjective health status and burden of illness in patients with chronic hypoparathyroidism will be evaluated by using a disease specific questionnaire as well as the SF-36.
Patients:
Patients will be recruited out of the patient population of the participating five medical centers.
Statistical Analysis:
Documentation and analysis will be performed at the Department of Medicine I, Endocrine and Diabetes Unit, University of Würzburg, Germany. Data will be documented after pseudonymisation in a data base. For further analysis data will be compared to sex- and age-matched controls.
- Conditions
- Hypoparathyroidism
- Keywords
- Hypoparathyroidism, Parathyroid Disease, Burden of Illness, SF-36, Quality of Life
- Medical subject headings
- Hypoparathyroidism, Parathyroid Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Burden of illness
Assessment of the burden of illness due to chronic hypoparathyroidism using a disease specific questionnaire to further investigate impairment in daily and professional life in comparison to the general German population (DEGS1, SHIP-2).
Measured: 12 - 24 months
Secondary outcomes (3)
Hypocalcemia
documentation of frequency of hypocalcemia under standard treatment
Measured: 12 - 24 months
Psychological disorders
documentation of frequency of anxiety and depression under standard treatment
Measured: 12 - 24 months
Subjective Health Status
Assessment of the subjective health status due to chronic hypoparathyroidism by Assessment of subjective health status in patients with chronic hypoparathyroidism
Measured: 12-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start1 Aug 2015
- Primary completion1 Dec 2017
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wuerzburg
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich, University Medical Center Rostock, Praxis Endokrinologie in Charlottenburg, Berlin, Charite University, Berlin, Germany, Endocrine Practice, Oldenburg, Germany
- Responsible party
- Principal investigator, Stefanie Hahner, University of Wuerzburg
- Investigators
- Stefanie Hahner, MD, Principal investigator, Wuerzburg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03437174
- Sponsor's protocol ID
- BOHEME-HP
- Status last verified
- Feb 2018
- First submitted
- 10 Feb 2018
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Arlt W, Fremerey C, Callies F, Reincke M, Schneider P, Timmermann W, Allolio B. Well-being, mood and calcium homeostasis in patients with hypoparathyroidism receiving standard treatment with calcium and vitamin D. Eur J Endocrinol. 2002 Feb;146(2):215-22. doi: 10.1530/eje.0.1460215.
PubMed 11834431Hadker N, Egan J, Sanders J, Lagast H, Clarke BL. Understanding the burden of illness associated with hypoparathyroidism reported among patients in the PARADOX study. Endocr Pract. 2014 Jul;20(7):671-9. doi: 10.4158/EP13328.OR.
PubMed 24449664Fuss CT, Engbers S, Reisch N, Hannemann A, Volzke H, Grabe HJ, Nauck M, Droste M, Willenberg HS, Rayes N, Fassnacht M, Quinkler M, Hahner S. Subjective health status, life performance and complications in chronic hypoparathyroidism - a German multicenter survey. Front Endocrinol (Lausanne). 2026 Mar 31;17:1723640. doi: 10.3389/fendo.2026.1723640. eCollection 2026.
PubMed 41987889
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burden of Illness and Disease Associated Emergencies in Chronic Hypoparathyroidism
- ClinicalTrials.gov ID
- NCT03437174
- Acronym / sponsor ID
- BOHEME-HP
- Conditions
- Hypoparathyroidism
- Keywords
- Hypoparathyroidism, Parathyroid Disease, Burden of Illness, SF-36, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- University of WuerzburgUniversity, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich, University Medical Center Rostock, Praxis Endokrinologie in Charlottenburg, Berlin, Charite University, Berlin, Germany, Endocrine Practice, Oldenburg, Germany
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 19 Feb 2018 (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.
Long-term conventional treatment of chronic hypoparathyroidism does not fully restore calcium homeostasis leading to increased morbidity, emergency events and reduced subjective health status. To further investigate general morbidity, hypocalcemic events, subjective and daily life performance in patients with chronic hypoparathyroidism a disease specific questionnaire, as well as the SF-36 are handed out.
Detailed description
Design:
In a cross-sectional trial the subjective health status and burden of illness in patients with chronic hypoparathyroidism will be evaluated by using a disease specific questionnaire as well as the SF-36.
Patients:
Patients will be recruited out of the patient population of the participating five medical centers.
Statistical Analysis:
Documentation and analysis will be performed at the Department of Medicine I, Endocrine and Diabetes Unit, University of Würzburg, Germany. Data will be documented after pseudonymisation in a data base. For further analysis data will be compared to sex- and age-matched controls.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with chronic hypo- and pseudohypoparathyroidism
Key inclusion criteria (3 listed)
- chronic hypoparathyroidism (>12 months) under established therapy
- chronic pseudohypoparathyroidism (>12 months) under established therapy
- written informed consent
Key exclusion criteria (2 listed)
- age <18 years
- no detailed documentation of hypo- or pseudohypoparathyroidism
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
Burden of illness
Time frame: 12 - 24 months
Assessment of the burden of illness due to chronic hypoparathyroidism using a disease specific questionnaire to further investigate impairment in daily and professional life in comparison to the general German population (DEGS1, SHIP-2).
3 secondary outcomes
Hypocalcemia
Time frame: 12 - 24 months
Psychological disorders
Time frame: 12 - 24 months
Subjective Health Status
Time frame: 12-24 months
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 19 Feb 2018.
- Background: PubMed 11834431Arlt W, Fremerey C, Callies F, Reincke M, Schneider P, Timmermann W, Allolio B. Well-being, mood and calcium homeostasis in patients with hypoparathyroidism receiving standard treatment with calcium and vitamin D. Eur J Endocrinol. 2002 Feb;146(2):215-22. doi: 10.1530/eje.0.1460215.
- Background: PubMed 24449664Hadker N, Egan J, Sanders J, Lagast H, Clarke BL. Understanding the burden of illness associated with hypoparathyroidism reported among patients in the PARADOX study. Endocr Pract. 2014 Jul;20(7):671-9. doi: 10.4158/EP13328.OR.
- Derived from this study: PubMed 41987889Fuss CT, Engbers S, Reisch N, Hannemann A, Volzke H, Grabe HJ, Nauck M, Droste M, Willenberg HS, Rayes N, Fassnacht M, Quinkler M, Hahner S. Subjective health status, life performance and complications in chronic hypoparathyroidism - a German multicenter survey. Front Endocrinol (Lausanne). 2026 Mar 31;17:1723640. doi: 10.3389/fendo.2026.1723640. eCollection 2026.
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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.
Stefanie Hahner, MD principal investigator
Wuerzburg University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoparathyroidism, run by University of Wuerzburg at 5 sites 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 3 inclusion and 2 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 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
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?
Burden of illness (time frame: 12 - 24 months). 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 NCT03437174, which also lists 3 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 19 Feb 2018.