Chronic HypoparathyroidismPaTHwayRNCT05214274
Multicenter Registry Study of Chronic Hypoparathyroidism in Chinese Adults
An observational study of Chronic Hypoparathyroidism, run by Peking University at 7 sites in China.
Trial summary
This multicenter registry study aims to understand the status of diagnosis and treatment, quality of life, medical costs and unmet medical needs of adult patients with chronic hypoparathyroidism in China. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hypoparathyroidism
- How many people
- 524 participants
- Where
- 7 sitesChina
- Study dates
- 10 Jan 2022to 22 Dec 2022
- 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: Part 1. All patients admitted between June 1, 2020 and May 31, 2021 will be searched in the information system according to predefined search criteria. Patients diagnosed with HP and those with suspected HP will be retrieved. Patients with definite diagnosis of chronic HP will serve as the study population of this part. Part 2. All local patients with a definite diagnosis of chronic HP and those with suspected HP will be invited to take part in the on-site survey. Part 3. The first 100 patients with definite chronic HP who participate in the on-site survey in the Peking Union Medical College Hospital will be invited to participate. Part 4. All endocrinologists at each center will be invited to participate.
Who may be able to join
- Existing diagnosis of HP
- Hypocalcemia plus neck surgery
- Hypocalcemia plus convulsions/tetany/epilepsy
- Hypocalcemia plus PTH<upper limit, and no hypoalbuminemia
- Hypocalcemia without any of the following conditions: neck surgery, convulsions/tetany/epilepsy, PTH testing, hypoalbuminemia, critical illness and vitamin D deficiency-related diseases.
- Hypocalcemia (albumin adjusted total calcium < lower limit) with inappropriate reduction of serum PTH level (PTH < upper limit).
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- The course of hypoparathyroidism should be more than 6 months.
- Part 2
- Patients with chronic HP confirmed through medical records review
- Patients with suspected HP confirmed through medical records review
- Obtain written informed consent
- Patients with chronic HP
- Participating in the on-site survey in the Peking Union Medical College Hospital
- Part 4
- Endocrinologists involved in HP care from 7 sites
- Obtain written informed consent
Who cannot join
- Age<18 at the time of screening
- Search criteria of suspected HP:
- Age<18 at the time of screening
- Diagnosis of chronic HP:
- Non-local residents
- Part 3
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Peking Union Medical College Hospital
Beijing, Beijing Municipality
The Second Xiangya Hospital of Central South University
Changsha, Hunan
West China Hospital of Sichuan University
Chengdu, Sichuan
The First Affiliated Hospital , Sun Yat-sen University
Guangzhou, Guangdong
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality
The First Hospital of China Medical University
Shenyang, Dongbei
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang
About this study
Official title: The Status of Diagnosis and Treatment of Chronic Hypoparathyroidism in Chinese Adults: a Multicenter Registry Study
This multicenter registry study aims to understand the status of diagnosis and treatment, quality of life, medical costs and unmet medical needs of adult patients with chronic hypoparathyroidism in China.
Read the detailed description
Hypoparathyroidism (HP) is a rare (orphan) endocrine disease with low calcium and inappropriately low circulating parathyroid hormone levels, most often in adults secondary to thyroid surgery. The present study contains four parts.
The first part is a multicenter registry study. According to our predefined search criteria determined through pilot study, all patients admitted between June 1, 2020 and May 31, 2021 will be searched from the hospital information system and patients diagnosed with HP and those with suspected HP will be retrieved. The diagnosis of all or a random sample of these patients will be reviewed by endocrinologists through medical records. Patients with a confirmed diagnosis of chronic HP will served as the study population of the first part of the study.
The second part is a multicenter hospital-based survey, to investigate the missed diagnosis, quality of life, medical costs, medical experience and unmet medical needs in adult patients with chronic HP. All local patients with definite chronic HP and those with suspected HP will be invited to participate in the hospital on-site investigation. Among them, suspected HP patients need to first undergo necessary examinations to confirm the diagnosis of HP.
The third part is the verification of the reliability and validity of two quality of life scales, the Short-Form Six-Dimension version 2 (SF-6Dv2) scale and Hypoparathyroidism Patient Experience Scale (HPES). The first 100 patients with chronic HP who participate in the on-site investigation in the Peking Union Medical College Hospital will be invited.
The fourth part is a survey on physicians about the unmet need of chronic HP. All endocrinologists from each site will be invited to take part in the survey.
- Conditions
- Chronic Hypoparathyroidism
- Being tested
- No intervention would be taken
- Keywords
- Registry study, Chronic hypoparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention would be takenOther
No intervention would be taken
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with different classification of hypoparathyroidism (HP)
HP is classified into postsurgical and non-postsurgical HP.
Measured: 0 day （cross-sectional）
The proportion of patients with different symptoms of HP
The most common symptoms of HP include tetany, seizures, laryngospasm, numbness, blood in the urine, renal colic and vision loss.
Measured: 0 day （cross-sectional）
The proportion of patients with positive Chvostek sign
Including the situation at the time of diagnosis and the current situation
Measured: 0 day （cross-sectional）
The proportion of patients with positive Trousseau's sign
Including the situation at the time of diagnosis and the current situation
Measured: 0 day （cross-sectional）
The proportion of patients with abnormal corrected calcium
Including the situation at the time of diagnosis and the current situation
Measured: 0 day （cross-sectional）
The proportion of patients with abnormal parathyroid hormone (PTH)
The situation at the time of diagnosis
Measured: 0 day （cross-sectional）
The proportion of patients with abnormal 24-hour urine calcium
Including the situation at the time of diagnosis and the current situation
Measured: 0 day （cross-sectional）
The proportion of patients with different first-visit reasons
First-visit reason was excerpted from previous medical records
Measured: 0 day （cross-sectional）
The proportion of patients with different first-visit departments
First-visit department was excerpted from previous medical records
Measured: 0 day （cross-sectional）
Secondary outcomes (10)
The prevalence of chronic HP in adults visiting top hospitals in China
Number of patients diagnosed with chronic HP / Total number of outpatients and inpatients during the year
Measured: 0 day （cross-sectional）
The proportion of patients with chronic HP receiving treatment
Number of patients receiving any kind of HP treatment/ Total number of patients diagnosed with chronic HP
Measured: 0 day （cross-sectional）
The proportion of patients with chronic HP meeting treatment targets
HP treatment targets defined as normal blood calcium levels or/+ normal urine calcium level
Measured: 0 day （cross-sectional）
The proportion of patients with HP complications
Number of patients with complications / Total number of patients with chronic HP
Measured: 0 day （cross-sectional）
The proportion of patients with missed diagnosis of chronic HP
Patients with missed diagnosis of chronic HP / Total number of patients with chronic HP
Measured: 0 day （cross-sectional）
The proportion of patients with previous experience of misdiagnosis of HP
Misdiagnosis experience of HP is defined as patients with chronic HP were previously diagnosed with other diseases due to related symptoms or hypocalcemia.
Measured: 0 day （cross-sectional）
Median medical costs
Medical costs contains of direct medical costs and indirect medical costs
Measured: 0 day （cross-sectional）
The mean score of Short-Form Six-Dimension version 2 (SF-6Dv2)
The SF-6Dv2 score ranges from 0.29 to 1, with higher scores indicating better performance.
Measured: 0 day （cross-sectional）
The mean score of Hypoparathyroidism Patient Experience Scale (HPES)
The HPES score ranges from 0 to 100, with lower scores indicating better performance.
Measured: 0 day （cross-sectional）
The proportion of patients with different unmet medical needs
Unmet medical needs for HP treatment and quality of life by patients and physicians
Measured: 0 day （cross-sectional）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start10 Jan 2022
- Primary completion22 Dec 2022
- Study completion22 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic HypoparathyroidismStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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
- Other
- Enrolment
- 524 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Shanghai 6th People's Hospital, First Hospital of China Medical University, Central South University, First Affiliated Hospital, Sun Yat-Sen University, West China Hospital, First Affiliated Hospital of Xinjiang Medical University
- Responsible party
- Sponsor
- Investigators
- Weibo Xia, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05214274
- Sponsor's protocol ID
- 2021-PaTHwayR
- Acronym
- PaTHwayR
- Status last verified
- May 2023
- First submitted
- 24 Dec 2021
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Status of Diagnosis and Treatment of Chronic Hypoparathyroidism in Chinese Adults: a Multicenter Registry Study
- ClinicalTrials.gov ID
- NCT05214274
- Acronym / sponsor ID
- PaTHwayR / 2021-PaTHwayR
- Conditions
- Chronic Hypoparathyroidism
- Keywords
- Registry study, Chronic hypoparathyroidism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 524 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Shanghai 6th People's Hospital, First Hospital of China Medical University, Central South University, First Affiliated Hospital, Sun Yat-Sen University, West China Hospital, First Affiliated Hospital of Xinjiang Medical University
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 28 Jan 2022 (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.
This multicenter registry study aims to understand the status of diagnosis and treatment, quality of life, medical costs and unmet medical needs of adult patients with chronic hypoparathyroidism in China.
Detailed description
Hypoparathyroidism (HP) is a rare (orphan) endocrine disease with low calcium and inappropriately low circulating parathyroid hormone levels, most often in adults secondary to thyroid surgery. The present study contains four parts.
The first part is a multicenter registry study. According to our predefined search criteria determined through pilot study, all patients admitted between June 1, 2020 and May 31, 2021 will be searched from the hospital information system and patients diagnosed with HP and those with suspected HP will be retrieved. The diagnosis of all or a random sample of these patients will be reviewed by endocrinologists through medical records. Patients with a confirmed diagnosis of chronic HP will served as the study population of the first part of the study.
The second part is a multicenter hospital-based survey, to investigate the missed diagnosis, quality of life, medical costs, medical experience and unmet medical needs in adult patients with chronic HP. All local patients with definite chronic HP and those with suspected HP will be invited to participate in the hospital on-site investigation. Among them, suspected HP patients need to first undergo necessary examinations to confirm the diagnosis of HP.
The third part is the verification of the reliability and validity of two quality of life scales, the Short-Form Six-Dimension version 2 (SF-6Dv2) scale and Hypoparathyroidism Patient Experience Scale (HPES). The first 100 patients with chronic HP who participate in the on-site investigation in the Peking Union Medical College Hospital will be invited.
The fourth part is a survey on physicians about the unmet need of chronic HP. All endocrinologists from each site will be invited to take part in the survey.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Part 1. All patients admitted between June 1, 2020 and May 31, 2021 will be searched in the information system according to predefined search criteria. Patients diagnosed with HP and those with suspected HP will be retrieved. Patients with definite diagnosis of chronic HP will serve as the study population of this part. Part 2. All local patients with a definite diagnosis of chronic HP and those with suspected HP will be invited to take part in the on-site survey. Part 3. The first 100 patients with definite chronic HP who participate in the on-site survey in the Peking Union Medical College Hospital will be invited to participate. Part 4. All endocrinologists at each center will be invited to participate.
Key inclusion criteria (16 listed)
- Existing diagnosis of HP
- Hypocalcemia plus neck surgery
- Hypocalcemia plus convulsions/tetany/epilepsy
- Hypocalcemia plus PTH<upper limit, and no hypoalbuminemia
- Hypocalcemia without any of the following conditions: neck surgery, convulsions/tetany/epilepsy, PTH testing, hypoalbuminemia, critical illness and vitamin D deficiency-related diseases.
Key exclusion criteria (6 listed)
- Age<18 at the time of screening
- Age<18 at the time of screening
- Non-local residents
- Part 3
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 intervention would be takenNo intervention would be taken | Other | – |
Primary outcome
The proportion of patients with different classification of hypoparathyroidism (HP)
Time frame: 0 day （cross-sectional）
HP is classified into postsurgical and non-postsurgical HP.
The proportion of patients with different symptoms of HP
Time frame: 0 day （cross-sectional）
The most common symptoms of HP include tetany, seizures, laryngospasm, numbness, blood in the urine, renal colic and vision loss.
The proportion of patients with positive Chvostek sign
Time frame: 0 day （cross-sectional）
Including the situation at the time of diagnosis and the current situation
The proportion of patients with positive Trousseau's sign
Time frame: 0 day （cross-sectional）
Including the situation at the time of diagnosis and the current situation
The proportion of patients with abnormal corrected calcium
Time frame: 0 day （cross-sectional）
Including the situation at the time of diagnosis and the current situation
The proportion of patients with abnormal parathyroid hormone (PTH)
Time frame: 0 day （cross-sectional）
The situation at the time of diagnosis
The proportion of patients with abnormal 24-hour urine calcium
Time frame: 0 day （cross-sectional）
Including the situation at the time of diagnosis and the current situation
The proportion of patients with different first-visit reasons
Time frame: 0 day （cross-sectional）
First-visit reason was excerpted from previous medical records
The proportion of patients with different first-visit departments
Time frame: 0 day （cross-sectional）
First-visit department was excerpted from previous medical records
10 secondary outcomes
The prevalence of chronic HP in adults visiting top hospitals in China
Time frame: 0 day （cross-sectional）
The proportion of patients with chronic HP receiving treatment
Time frame: 0 day （cross-sectional）
The proportion of patients with chronic HP meeting treatment targets
Time frame: 0 day （cross-sectional）
The proportion of patients with HP complications
Time frame: 0 day （cross-sectional）
The proportion of patients with missed diagnosis of chronic HP
Time frame: 0 day （cross-sectional）
The proportion of patients with previous experience of misdiagnosis of HP
Time frame: 0 day （cross-sectional）
Median medical costs
Time frame: 0 day （cross-sectional）
The mean score of Short-Form Six-Dimension version 2 (SF-6Dv2)
Time frame: 0 day （cross-sectional）
The mean score of Hypoparathyroidism Patient Experience Scale (HPES)
Time frame: 0 day （cross-sectional）
The proportion of patients with different unmet medical needs
Time frame: 0 day （cross-sectional）
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 24 May 2023.
- Individual participant dataSharing planned: Undecided
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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.
Weibo Xia principal investigator
Peking Union Medical College Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hypoparathyroidism, run by Peking University at 7 sites in China.
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 16 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: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. 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?
The proportion of patients with different classification of hypoparathyroidism (HP) (time frame: 0 day （cross-sectional）). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 May 2023.