Multicenter Registry Study of Chronic Hypoparathyroidism in Chinese Adults (PaTHwayR)

Peking University

Status

Completed

Conditions

Chronic Hypoparathyroidism

Treatments

Other: No intervention would be taken

Study type

Observational

Funder types

Other

Identifiers

NCT05214274

2021-PaTHwayR

Details and patient eligibility

About

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.

Full 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.

Enrollment

524 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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: