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

Recruiting · NCT06867952 · Interventional (participants receive a specific treatment) · Lead sponsor: S.LAB (SOLOWAYS)

View the official record on ClinicalTrials.gov →

Interventions studied

Vitamin K2 plus vitamin D3

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.

Who can take part

Age range

40 Years to 75 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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.

Where it is running

1 location listed.

Center For New Medical Technologies - Novosibirsk, Russia

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →