Actively Recruiting
A Pilot Study of Vitamin K2 (Menaquinone-7, Soloways ™) in Patients With Osteopenia/Osteoporosis Carrying a VDR Gene Variant
Led by S.LAB (SOLOWAYS) · Updated on 2025-03-17
40
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
Sponsors
S
S.LAB (SOLOWAYS)
Lead Sponsor
C
Center for New Medical Technologies, Novosibirsk, Russia
Collaborating Sponsor
AI-Summary
What this Trial Is About
This pilot, genotype-stratified clinical trial aims to evaluate the safety and preliminary efficacy of vitamin K2 (menaquinone-7, MK-7) supplementation in patients with low bone mineral density (osteopenia or osteoporosis) who carry a specific "unfavorable" variant in the vitamin D receptor (VDR) gene (e.g., BsmI or ApaI polymorphisms). The trial will compare improvements in bone health and related biomarkers between two cohorts: (1) homozygous carriers of the VDR variant and (2) non-variant carriers (wild-type). Investigators hypothesize that MK-7 supplementation will lead to greater improvements in bone mineral density (BMD) and bone turnover markers in the homozygous variant group due to their potentially reduced baseline response to vitamin D signaling.
CONDITIONS
Official Title
A Pilot Study of Vitamin K2 (Menaquinone-7, Soloways ™) in Patients With Osteopenia/Osteoporosis Carrying a VDR Gene Variant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 40 to 75 years with a confirmed diagnosis of osteopenia or osteoporosis by DXA (T-score 1.0 or lower)
- Stable dietary habits and willingness to maintain current exercise routines during the study
- Willingness to undergo genetic testing for the VDR gene variant
- For the VDR Variant Cohort: confirmed homozygous "unfavorable" VDR gene variant (e.g., BsmI or ApaI)
- For the Non-Variant Cohort: confirmed absence of the "unfavorable" VDR gene variant (wild-type)
You will not qualify if you...
- Current or recent (within 3 months) use of high-dose bisphosphonates, anabolic agents (e.g., teriparatide), or selective estrogen receptor modulators
- Known allergy or sensitivity to vitamin K or vitamin D supplements
- Severe kidney or liver problems, uncontrolled hyperthyroidism, or other serious health conditions affecting bone metabolism
- Pregnancy or breastfeeding
- Unable or unwilling to provide informed consent or follow study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Center For New Medical Technologies
Novosibirsk, Russia, 630090
Actively Recruiting
Research Team
A
Andrei AV Ponomarenko, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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