Clinical Trial: Association between equol production status and lumbar degenerative spondylolisthesis in postmenopausal women (Japan)

Tokyo, April 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061146) titled 'Association between equol production status and lumbar degenerative spondylolisthesis in postmenopausal women' on April 4.

Study Type: Observational

Primary Sponsor: Institute - Institute of Science Tokyo

Condition: Condition - lumbar degenerative spondylolisthesis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate the association between lumbar degenerative spondylolisthesis status and equol-producing ability in postmenopausal women Basic objectives2 - Others

Eligibility: Age-lower limit - 50 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 Size - 200

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 04 Month 01 Day Anticipated trial start date - 2026 Year 05 Month 01 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069871

Disclaimer: Curated by HT Syndication.