UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061146 |
|---|---|
| Receipt number | R000069871 |
| Scientific Title | Association between equol production status and lumbar degenerative spondylolisthesis in postmenopausal women |
| Date of disclosure of the study information | 2026/04/04 |
| Last modified on | 2026/04/03 10:27:30 |
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Basic information
Public title
Association between equol production status and lumbar degenerative spondylolisthesis in postmenopausal women
Acronym
Association between equol production status and lumbar degenerative spondylolisthesis in postmenopausal women
Scientific Title
Association between equol production status and lumbar degenerative spondylolisthesis in postmenopausal women
Scientific Title:Acronym
Association between equol production status and lumbar degenerative spondylolisthesis in postmenopausal women
Region
| Japan |
Condition
Condition
lumbar degenerative spondylolisthesis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association between lumbar degenerative spondylolisthesis status and equol-producing ability in postmenopausal women
Basic objectives2
Others
Basic objectives -Others
To identify factors associated with lumbar degenerative spondylolisthesis, excluding urinary equol concentration
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
urinary equol concentration
Key secondary outcomes
Demographic and clinical variables, including age at the time of urinary equol measurement, sex, height, weight, body mass index (BMI), medical history, medication use, parity, age at menopause, frequency of soy intake, and bone mineral density.
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
| 50 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
Lumbar degenerative spondylolisthesis group:
Female patients aged 50 to 64 years with imaging-confirmed lumbar degenerative spondylolisthesis
Control group:
Women aged 50 to 64 years who underwent equol testing through the Healthcare Systems service, consented to use of their results for research, had no low back pain, and no prior diagnosis of lumbar spondylolisthesis
Key exclusion criteria
Lumbar degenerative spondylolisthesis group:
History of hormone therapy, equol supplement use (within 3 months), vertebral fracture or spondylolysis history, antibiotic use (within 2 weeks), heavy lifting occupation, soy allergy, severe hepatic or renal dysfunction, dialysis, rheumatoid arthritis, inflammatory spondylitis or DISH, and investigator-determined ineligibility
Control group:
History of lumbar spine surgery, hormone therapy, equol supplement use (within 3 months), vertebral fracture or spondylolysis history, antibiotic use (within 2 weeks), heavy lifting occupation, soy allergy, severe hepatic or renal dysfunction, dialysis, rheumatoid arthritis, inflammatory spondylitis or DISH, and investigator-determined ineligibility
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Hirai |
Organization
Institute of Science Tokyo
Division name
Department of Orthopaedic and Spinal Surgery
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
0358035678
hirai.orth@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Miyamoto |
| Middle name | |
| Last name | Reina |
Organization
Institute of Science Tokyo
Division name
Department of Orthopaedic and Spinal Surgery, Graduate School of Medical and Dental Sciences, Instit
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5279
Homepage URL
miyamoto.r.d077@m.isct.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
Institute of Science Tokyo
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Bioethics Group, Research Infrastructure Division, Research Promotion Department
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
Tel
03-5803-4547
rinri.adm@tmd.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
| 2026 | Year | 04 | Month | 04 | 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 | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Currently under ethical review
Management information
Registered date
| 2026 | Year | 04 | Month | 03 | Day |
Last modified on
| 2026 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069871
