Multicenter Registry Study of Chronic Hypoparathyroidism in Chinese Adults
- Conditions
- Chronic Hypoparathyroidism
- Registration Number
- NCT05214274
- Lead Sponsor
- Peking University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 524
- Existing diagnosis of HP
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of patients with different symptoms of HP 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 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 0 day （cross-sectional） Including the situation at the time of diagnosis and the current situation
The proportion of patients with different classification of hypoparathyroidism (HP) 0 day （cross-sectional） HP is classified into postsurgical and non-postsurgical HP.
The proportion of patients with abnormal corrected calcium 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 0 day （cross-sectional） First-visit reason was excerpted from previous medical records
The proportion of patients with abnormal parathyroid hormone (PTH) 0 day （cross-sectional） The situation at the time of diagnosis
The proportion of patients with abnormal 24-hour urine calcium 0 day （cross-sectional） Including the situation at the time of diagnosis and the current situation
The proportion of patients with different first-visit departments 0 day （cross-sectional） First-visit department was excerpted from previous medical records
- Secondary Outcome Measures
Name Time Method The proportion of patients with previous experience of misdiagnosis of HP 0 day （cross-sectional） Misdiagnosis experience of HP is defined as patients with chronic HP were previously diagnosed with other diseases due to related symptoms or hypocalcemia.
Median medical costs 0 day （cross-sectional） Medical costs contains of direct medical costs and indirect medical costs
The prevalence of chronic HP in adults visiting top hospitals in China 0 day （cross-sectional） Number of patients diagnosed with chronic HP / Total number of outpatients and inpatients during the year
The proportion of patients with chronic HP receiving treatment 0 day （cross-sectional） Number of patients receiving any kind of HP treatment/ Total number of patients diagnosed with chronic HP
The mean score of Hypoparathyroidism Patient Experience Scale (HPES) 0 day （cross-sectional） The HPES score ranges from 0 to 100, with lower scores indicating better performance.
The mean score of Short-Form Six-Dimension version 2 (SF-6Dv2) 0 day （cross-sectional） The SF-6Dv2 score ranges from 0.29 to 1, with higher scores indicating better performance.
The proportion of patients with chronic HP meeting treatment targets 0 day （cross-sectional） HP treatment targets defined as normal blood calcium levels or/+ normal urine calcium level
The proportion of patients with missed diagnosis of chronic HP 0 day （cross-sectional） Patients with missed diagnosis of chronic HP / Total number of patients with chronic HP
The proportion of patients with HP complications 0 day （cross-sectional） Number of patients with complications / Total number of patients with chronic HP
The proportion of patients with different unmet medical needs 0 day （cross-sectional） Unmet medical needs for HP treatment and quality of life by patients and physicians
Trial Locations
- Locations (7)
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
The First Hospital of China Medical University
🇨🇳Shenyang, Dongbei, China
The First Affiliated Hospital , Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Shanghai Sixth People's Hospital
🇨🇳Shanghai, Shanghai, China
The First Affiliated Hospital of Xinjiang Medical University
🇨🇳Urumqi, Xinjiang, China