UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054177 |
|---|---|
| Receipt number | R000061686 |
| Scientific Title | Analysis of bone microstructures using high-resolution peripheral quantitative computed tomography (HR-pQCT) in patients with Acromegaly |
| Date of disclosure of the study information | 2024/05/01 |
| Last modified on | 2024/04/16 13:12:40 |
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Basic information
Public title
Analysis of bone microstructures using high-resolution peripheral quantitative computed tomography (HR-pQCT) in patients with Acromegaly
Acronym
Analysis of bone microstructures using HR-pQCT in Acromegaly
Scientific Title
Analysis of bone microstructures using high-resolution peripheral quantitative computed tomography (HR-pQCT) in patients with Acromegaly
Scientific Title:Acronym
Analysis of bone microstructures using HR-pQCT in Acromegaly
Region
| Japan |
Condition
Condition
Acromegaly
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze bone microstructural changes using HR-pQCT in Japanese patients with Acromegaly.
Basic objectives2
Others
Basic objectives -Others
Observational study of bone microstructure
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bone microstructure and metabolic markers compared to those of healthy control
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
patients with Acromegaly
Key exclusion criteria
1. Patients with bone metabolic disease
2. Patients treated at present or within 12 months with bisphosphonate, teriparatide, anti-RANKL Ab, and romosozumab.
3. Patients administered with steroids.
4. Patients complicated with malignancy.
5. Pregnant or breastfeeding.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ai |
| Middle name | |
| Last name | Haraguchi |
Organization
Nagasaki University Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
8528501
Address
1-7-1 Sakamoto, Nagasaki
TEL
0958197200
a-haraguchi@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Ai |
| Middle name | |
| Last name | Haraguchi |
Organization
Nagasaki University Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
8528501
Address
1-7-1 Sakamoto, Nagasaki
TEL
0958197200
Homepage URL
a-haraguchi@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital Clinical Research Ethics Committee
Address
1-7-1 Sakamoto, Nagasaki-city, Nagasaki
Tel
095-819-7229
gaibushikin@ml.nagasaki-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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 01 | 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
| 2024 | Year | 03 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2039 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Comparison between changes in bone microstructure in HR-pQCT and metabolic markers in untreated and previously treated acromegaly patients and those in healthy controls
Baseline comparison of the above between untreated and previously treated acromegaly patients
Changes in the above items in both acromegaly patient groups
Management information
Registered date
| 2024 | Year | 04 | Month | 17 | Day |
Last modified on
| 2024 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061686
