Multicenter Registry Study of Chronic Hypoparathyroidism in Chinese Adults

Chronic Hypoparathyroidism Clinical Trial

— PaTHwayR  

Official title:

The Status of Diagnosis and Treatment of Chronic Hypoparathyroidism in Chinese Adults: a Multicenter Registry Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05214274
• Other study ID #: 2021-PaTHwayR
• Status: Completed
• Start date: January 10, 2022
• Est. completion date: December 22, 2022

Study information

• Verified date: May 2023
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 524
• Est. completion date: December 22, 2022
• Est. primary completion date: December 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

This study consists of four parts, the eligibility criteria of each part is described below:

Part 1:

Search criteria of chronic HP:

Inclusion Criteria:

• Existing diagnosis of HP

Exclusion Criteria:

• Age<18 at the time of screening

Search criteria of suspected HP:

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Age<18 at the time of screening

Diagnosis of chronic HP:

Inclusion Criteria:

• Hypocalcemia (albumin adjusted total calcium < lower limit) with inappropriate reduction of serum PTH level (PTH < upper limit).

• The course of hypoparathyroidism should be more than 6 months.

Part 2

Inclusion Criteria:

• Patients with chronic HP confirmed through medical records review

• Patients with suspected HP confirmed through medical records review

• Obtain written informed consent

Exclusion Criteria:

• Non-local residents

Part 3

Inclusion Criteria:

• Patients with chronic HP

• Participating in the on-site survey in the Peking Union Medical College Hospital

Part 4

Inclusion criteria:

• Endocrinologists involved in HP care from 7 sites

• Obtain written informed consent

Related Conditions & MeSH terms

• Chronic Hypoparathyroidism
• Hypoparathyroidism

Intervention

Other:
• No intervention would be taken
No intervention would be taken

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	The First Affiliated Hospital , Sun Yat-sen University	Guangzhou	Guangdong
China	Shanghai Sixth People's Hospital	Shanghai	Shanghai
China	The First Hospital of China Medical University	Shenyang	Dongbei
China	The First Affiliated Hospital of Xinjiang Medical University	Urumqi	Xinjiang

Sponsors (8)

Lead Sponsor	Collaborator
Peking University	Central South University, First Affiliated Hospital of Xinjiang Medical University, First Affiliated Hospital, Sun Yat-Sen University, First Hospital of China Medical University, Peking Union Medical College Hospital, Shanghai 6th People's Hospital, West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients with different classification of hypoparathyroidism (HP)	HP is classified into postsurgical and non-postsurgical HP.	0 day (cross-sectional)
Primary	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.	0 day (cross-sectional)
Primary	The proportion of patients with positive Chvostek sign	Including the situation at the time of diagnosis and the current situation	0 day (cross-sectional)
Primary	The proportion of patients with positive Trousseau's sign	Including the situation at the time of diagnosis and the current situation	0 day (cross-sectional)
Primary	The proportion of patients with abnormal corrected calcium	Including the situation at the time of diagnosis and the current situation	0 day (cross-sectional)
Primary	The proportion of patients with abnormal parathyroid hormone (PTH)	The situation at the time of diagnosis	0 day (cross-sectional)
Primary	The proportion of patients with abnormal 24-hour urine calcium	Including the situation at the time of diagnosis and the current situation	0 day (cross-sectional)
Primary	The proportion of patients with different first-visit reasons	First-visit reason was excerpted from previous medical records	0 day (cross-sectional)
Primary	The proportion of patients with different first-visit departments	First-visit department was excerpted from previous medical records	0 day (cross-sectional)
Secondary	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	0 day (cross-sectional)
Secondary	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	0 day (cross-sectional)
Secondary	The proportion of patients with chronic HP meeting treatment targets	HP treatment targets defined as normal blood calcium levels or/+ normal urine calcium level	0 day (cross-sectional)
Secondary	The proportion of patients with HP complications	Number of patients with complications / Total number of patients with chronic HP	0 day (cross-sectional)
Secondary	The proportion of patients with missed diagnosis of chronic HP	Patients with missed diagnosis of chronic HP / Total number of patients with chronic HP	0 day (cross-sectional)
Secondary	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.	0 day (cross-sectional)
Secondary	Median medical costs	Medical costs contains of direct medical costs and indirect medical costs	0 day (cross-sectional)
Secondary	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.	0 day (cross-sectional)
Secondary	The mean score of Hypoparathyroidism Patient Experience Scale (HPES)	The HPES score ranges from 0 to 100, with lower scores indicating better performance.	0 day (cross-sectional)
Secondary	The proportion of patients with different unmet medical needs	Unmet medical needs for HP treatment and quality of life by patients and physicians	0 day (cross-sectional)