A Pilot Study of Vitamin K2 (Menaquinone-7, Soloways ™) in Patients With Osteopenia/Osteoporosis Carrying a VDR Gene Variant

Launched by S.LAB (SOLOWAYS) · Mar 4, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring whether vitamin K2 (specifically, a form called menaquinone-7) can help improve bone health in adults who have low bone density conditions known as osteopenia or osteoporosis. The study focuses on participants who have a specific genetic variant in the vitamin D receptor (VDR gene) that may affect how their bodies respond to vitamin D. Researchers want to see if those with this variant benefit more from vitamin K2 supplementation compared to those without the variant.

To be eligible for this study, participants need to be between 40 and 75 years old and have a diagnosis of osteopenia or osteoporosis based on bone density tests. They should also have stable eating habits and be willing to maintain their current exercise routines. Participants will need to provide a sample for genetic testing to confirm their VDR status. Throughout the study, they can expect to take the vitamin K2 supplement and have their bone health monitored. It's important to note that certain medical conditions and recent use of specific medications may exclude someone from participating.

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Eligibility criteria

• Inclusion Criteria:
• • Adults aged 40-75 years with a confirmed DXA-based diagnosis of osteopenia or osteoporosis (T-score ≤ -1.0).
• • Stable dietary habits and willingness to maintain current exercise regimen throughout the study.
• • Willingness to undergo genotyping for the VDR variant. For the VDR Variant Cohort: confirmed homozygous "unfavorable" variant (e.g., BsmI or ApaI).
• • For the Non-Variant Cohort: confirmed absence of the "unfavorable" allele (wild-type).
• Exclusion Criteria:
• • Current or recent (last 3 months) use of high-dose bisphosphonates, anabolic agents (e.g., teriparatide), or selective estrogen receptor modulators (SERMs). Known allergy or hypersensitivity to vitamin K or vitamin D supplements.
• • Severe renal or hepatic dysfunction, uncontrolled hyperthyroidism, or other significant comorbidities that could confound bone metabolism assessments.
• • Pregnancy or breastfeeding.
• • Inability or unwillingness to provide informed consent or to comply with study procedures.