Multicenter Registry Study of Chronic Hypoparathyroidism in Chinese Adults

NCT05214274 | Completed DMC

• 1 other identifier: 2021-PaTHwayR
• Study Type: observational
• Target: 524
• Locations: 1 country
• Sites: 7

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.

Conditions

Chronic Hypoparathyroidism

Keywords

Registry study; Chronic hypoparathyroidism

Outcome Measures

Primary Outcomes (9)

• The proportion of patients with different classification of hypoparathyroidism (HP)

  HP is classified into postsurgical and non-postsurgical HP.

  0 day （cross-sectional）

• The proportion of patients with different symptoms of HP

  The most common symptoms of HP include tetany, seizures, laryngospasm, numbness, blood in the urine, renal colic and vision loss.

  0 day （cross-sectional）

• The proportion of patients with positive Chvostek sign

  Including the situation at the time of diagnosis and the current situation

  0 day （cross-sectional）

• The proportion of patients with positive Trousseau's sign

  Including the situation at the time of diagnosis and the current situation

  0 day （cross-sectional）

• The proportion of patients with abnormal corrected calcium

  Including the situation at the time of diagnosis and the current situation

  0 day （cross-sectional）

• The proportion of patients with abnormal parathyroid hormone (PTH)

  The situation at the time of diagnosis

  0 day （cross-sectional）

• The proportion of patients with abnormal 24-hour urine calcium

  Including the situation at the time of diagnosis and the current situation

  0 day （cross-sectional）

• The proportion of patients with different first-visit reasons

  First-visit reason was excerpted from previous medical records

  0 day （cross-sectional）

• The proportion of patients with different first-visit departments

  First-visit department was excerpted from previous medical records

  0 day （cross-sectional）

Secondary Outcomes (10)

• The prevalence of chronic HP in adults visiting top hospitals in China

  0 day （cross-sectional）

• The proportion of patients with chronic HP receiving treatment

  0 day （cross-sectional）

• The proportion of patients with chronic HP meeting treatment targets

  0 day （cross-sectional）

• The proportion of patients with HP complications

  0 day （cross-sectional）

• The proportion of patients with missed diagnosis of chronic HP

  0 day （cross-sectional）

Interventions

No intervention would be taken OTHER

No intervention would be taken

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Existing diagnosis of HP

You may not qualify if:

• Age\<18 at the time of screening
• Search criteria of suspected 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.
• Age\<18 at the time of screening
• Diagnosis of chronic HP:
• 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
• Non-local residents

Sponsors & Collaborators

• Peking University: lead
• Peking Union Medical College Hospital: collaborator
• Shanghai 6th People's Hospital: collaborator
• First Hospital of China Medical University: collaborator
• Central South University: collaborator
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• West China Hospital: collaborator
• First Affiliated Hospital of Xinjiang Medical University: collaborator

Study Sites (7)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

The First Hospital of China Medical University

Shenyang, Dongbei, China

Location

The First Affiliated Hospital , Sun Yat-sen University

Guangzhou, Guangdong, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Location

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Location

Study Officials

• Weibo Xia

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2021
• First Posted: January 28, 2022
• Study Start: January 10, 2022
• Primary Completion: December 22, 2022
• Study Completion: December 22, 2022
• Last Updated: May 24, 2023

Record last verified: 2023-05

Locations

CN (7)