UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060482 |
|---|---|
| Receipt number | R000069146 |
| Scientific Title | Exploratory Analysis of Disease and Treatment Burden for Patients with Hypoparathyroidism: A Qualitative Study of Effects on Daily Life |
| Date of disclosure of the study information | 2026/04/20 |
| Last modified on | 2026/03/26 14:48:59 |
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Basic information
Public title
Exploratory Analysis of Disease and Treatment Burden for Patients with Hypoparathyroidism: A Qualitative Study of Effects on Daily Life
Acronym
Exploratory Analysis of Disease and Treatment Burden for Patients with Hypoparathyroidism: A Qualitative Study of Effects on Daily Life
Scientific Title
Exploratory Analysis of Disease and Treatment Burden for Patients with Hypoparathyroidism: A Qualitative Study of Effects on Daily Life
Scientific Title:Acronym
Exploratory Analysis of Disease and Treatment Burden for Patients with Hypoparathyroidism: A Qualitative Study of Effects on Daily Life
Region
| Japan |
Condition
Condition
Hypoparathyroidism
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the disease burden (physical, psychological, and social aspects) and treatment burden (conventional treatment problems) faced by patients with hypoparathyroidism in this study.
Basic objectives2
Others
Basic objectives -Others
Evaluating QOL, worries, and physical, psychological, and social burdens from the patient's perspective.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
- Burden of Disease (Physical, Emotional, and Social Aspects)
- Treatment Burden (Traditional Pain Points)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Upon obtaining informed consent:
(1) Patients >= 18 years of age
(2) patients with a confirmed diagnosis of hypoparathyroidism
(3) Previously treated with activated vitamin D
(4) Patients with laboratory data for serum calcium, * serum phosphorus, and intact PTH
(5) Patients who can voluntarily consent to participate in the study
*Basically, an albumin-corrected value will be used, but if not available, a corrected calcium value will be calculated from the serum calcium value using Payne's formula.
- Payne's formula: corrected Ca level (mg/dL) = measured Ca level (mg/dL) + (4 -Alb level (g/dL))
At enrollment:
(1) Experienced distress due to hypoparathyroidism
Key exclusion criteria
Upon obtaining informed consent:
(1) Diagnosis of pseudohypoparathyroidism
(2) Patients considered by physician to be ineligible
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Ashida |
Organization
Department of Internal Medicine, Kurume University School of Medicine
Division name
Division of Endocrine and metabolic disease
Zip code
830 0011
Address
67 Asahi machi, Kurume shi, Fukuoka 830 0011, Japan
TEL
0942-31-7563
ashida@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Ashida |
Organization
Department of Internal Medicine, Kurume University School of Medicine
Division name
Division of Endocrine and metabolic disease
Zip code
830 0011
Address
67 Asahi machi, Kurume shi, Fukuoka 830 0011, Japan
TEL
0942-31-7563
Homepage URL
ashida@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
Funding Source
Organization
Teijin Pharma Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kurume University Medical Ethics Committee
Address
67 Asahi machi, Kurume shi, Fukuoka 830 0011, Japan
Tel
0942-35-3311
i_rinri@kurume-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
久留米大学（福岡県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a qualitative study using cross-sectional, non-interventional, semi-structured interviews. Our goal is to conduct and analyze interviews with at least 10 patients with hypoparathyroidism.
Management information
Registered date
| 2026 | Year | 01 | Month | 27 | Day |
Last modified on
| 2026 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069146
