Clinical trial NCT05214274: Multicenter Registry Study of Chronic Hypoparathyroidism in Chinese Adults
Official title: The Status of Diagnosis and Treatment of Chronic Hypoparathyroidism in Chinese Adults: a Multicenter Registry Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hypoparathyroidism
Keywords: Registry study
Chronic hypoparathyroidism
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College Hospital
name: Shanghai 6th People's Hospital
name: First Hospital of China Medical University
name: Central South University
name: First Affiliated Hospital, Sun Yat-Sen University
name: West China Hospital
name: First Affiliated Hospital of Xinjiang Medical University
First posted: 2022-01-28
Enrollment: 524
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The proportion of patients with different classification of hypoparathyroidism (HP)
timeFrame: 0 day （cross-sectional）
measure: The proportion of patients with different symptoms of HP
timeFrame: 0 day （cross-sectional）
measure: The proportion of patients with positive Chvostek sign
timeFrame: 0 day （cross-sectional）
measure: The proportion of patients with positive Trousseau's sign
timeFrame: 0 day （cross-sectional）
measure: The proportion of patients with abnormal corrected calcium
timeFrame: 0 day （cross-sectional）
measure: The proportion of patients with abnormal parathyroid hormone (PTH)
timeFrame: 0 day （cross-sectional）
measure: The proportion of patients with abnormal 24-hour urine calcium
timeFrame: 0 day （cross-sectional）
measure: The proportion of patients with different first-visit reasons
timeFrame: 0 day （cross-sectional）
measure: The proportion of patients with different first-visit departments
timeFrame: 0 day （cross-sectional）
Secondary outcomes:
measure: The prevalence of chronic HP in adults visiting top hospitals in China
timeFrame: 0 day （cross-sectional）
measure: The proportion of patients with chronic HP receiving treatment
timeFrame: 0 day （cross-sectional）
measure: The proportion of patients with chronic HP meeting treatment targets
timeFrame: 0 day （cross-sectional）
measure: The proportion of patients with HP complications
timeFrame: 0 day （cross-sectional）
measure: The proportion of patients with missed diagnosis of chronic HP
timeFrame: 0 day （cross-sectional）
measure: The proportion of patients with previous experience of misdiagnosis of HP
timeFrame: 0 day （cross-sectional）
measure: Median medical costs
timeFrame: 0 day （cross-sectional）
measure: The mean score of Short-Form Six-Dimension version 2 (SF-6Dv2)
timeFrame: 0 day （cross-sectional）
measure: The mean score of Hypoparathyroidism Patient Experience Scale (HPES)
timeFrame: 0 day （cross-sectional）
measure: The proportion of patients with different unmet medical needs
timeFrame: 0 day （cross-sectional）
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Dongbei
city: Guangzhou
country: China
facility: The First Affiliated Hospital , Sun Yat-sen University
state: Guangdong
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Urumqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
Study officials:
affiliation: Peking Union Medical College Hospital
name: Weibo Xia
role: PRINCIPAL_INVESTIGATOR
References: