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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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05214274
Study type Observational
Source Peking University
Contact Huijuan Li
Phone 82805564
Email [email protected]
Status Recruiting
Phase
Start date January 10, 2022
Completion date December 31, 2022

See also
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Completed NCT02910466 - A Study of Extended Use of Recombinant Human Parathyroid Hormone (rhPTH(1-84)) in Hypoparathyroidism Phase 4
Completed NCT03425747 - Efficacy of Calcium Citrate Versus Calcium Carbonate for the Management of Chronic Hypoparathyroidism Phase 4
Not yet recruiting NCT03878953 - A Clinical Study of rhPTH(1-84) Treatment in Japanese Participants With Chronic Hypoparathyroidism Phase 3