UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053904 |
|---|---|
| Receipt number | R000061534 |
| Scientific Title | Evaluation of bone mineral density, bone metabolism and bone quality markers in gynecological patients at risk for bone metabolism abnormalities |
| Date of disclosure of the study information | 2024/03/19 |
| Last modified on | 2024/09/18 12:46:02 |
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Basic information
Public title
Tests to see the effects on bones (bone quantity, bone quality) caused by gynecological diseases
Acronym
Gynecological Bone Quality Evaluation Test
Scientific Title
Evaluation of bone mineral density, bone metabolism and bone quality markers in gynecological patients at risk for bone metabolism abnormalities
Scientific Title:Acronym
Gynecological Bone Quality Evaluation Test
Region
| Japan |
Condition
Condition
Menopause, Amenorrhea, Surgical menopause
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will evaluate changes in bone mineral density, bone metabolism markers, and bone quality markers in gynecological patients at risk for bone metabolism abnormalities, such as spontaneous menopause, amenorrhea before age 40, and artificial menopause due to malignant tumor surgery.
Basic objectives2
Others
Basic objectives -Others
Verification of optimal treatment methods, including drug selection and timing of initiation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount and rate of change in bone strength factors (bone mineral density, bone metabolism markers, bone quality markers) during the follow-up period
Key secondary outcomes
Presence or absence of adverse events
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Menopausal patients between the ages of 16 and 40 years who visited the Department of Obstetrics and Gynecology, The Jikei University Hospital for more than 2 years, patients who underwent bilateral adnexectomy before menopause at the age of 16 years or older, and spontaneous menopause patients.
Key exclusion criteria
Patient unable to give consent
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kanae |
| Middle name | |
| Last name | Matsuno |
Organization
The Jikei University School of Medicine
Division name
Obstetrics and Gynecology
Zip code
105-8461
Address
3-25-8, Nishi-Shimbashi, Minato-ku,Tokyo
TEL
0334331111
kanaessk@gmail.com
Public contact
Name of contact person
| 1st name | Kanae |
| Middle name | |
| Last name | Matsuno |
Organization
The Jikei University School of Medicine
Division name
Obstetrics and Gynecology
Zip code
105-8461
Address
3-25-8, Nishi-Shimbashi, Minato-ku,Tokyo
TEL
0334331111
Homepage URL
kanaessk@gmail.com
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Jikei University School of Medicine
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
The Jikei University School of Medicine
Address
3-25-8, Nishi-Shimbashi, Minato-ku,Tokyo
Tel
0334331111
kanaessk@gmail.com
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 | 03 | Month | 19 | 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
Suspended
Date of protocol fixation
| 2017 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study design is a prospective cohort study
Subjects will be recruited from all patients who visited our institution on or after 12/2017 and met the selection criteria
The following tests will be performed: bone mineral density, blood and urine tests (general blood test, TRACP-5b as bone metabolism marker, bone ALP, blood homocysteine as bone quality marker (blood requirement 72 ml), urine pentosidine (urine collection 2 ml)).
Management information
Registered date
| 2024 | Year | 03 | Month | 19 | Day |
Last modified on
| 2024 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061534
