Multicenter Registry Study of Chronic Hypoparathyroidism in Chinese Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

524 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-10

Study Completion Date

2022-12-22

Brief Summary

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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.

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Detailed Description

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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

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Chronic Hypoparathyroidism

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Interventions

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No intervention would be taken

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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).
* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No