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

ConditionsOsteoporosisOsteopenia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorS.LAB (SOLOWAYS)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vitamin K2 plus vitamin D3

    Dietary supplement

    Intervention: Vitamin K2 (menaquinone-7), 100-200 µg/day plus vitamin D3 (800- 1000 IU/day) for 6-9 months.

  • Vitamin K2 plus vitamin D3

    Dietary supplement

    Intervention: Vitamin K2 (menaquinone-7), 100-200 µg/day plus vitamin D3 (800- 1000 IU/day) for 6-9 months.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: Non-Variant (Control) CohortExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Bone Mineral Density (BMD)

Assessed by DXA (Dual-Energy X-Ray Absorptiometry) scans

Time frame
9 months

Secondary outcomes

1

Change in Serum Osteocalcin Levels

Time frame
9 months
2

Change in Bone Turnover Markers

Serum C-Terminal Telopeptide (CTX): Measured in ng/mL as a marker of bone resorption. Serum Procollagen Type I N-Terminal Propeptide (P1NP): Measured in ng/mL as a marker of bone formation. Each marker will be reported separately as the mean change from baseline to 9 months.

Time frame
9 months
3

Adverse Events and TolerabilityIncidence of Treatment-Related Adverse Events as Assessed by CTCAE v5.0

The number and percentage of participants experiencing treatment-related adverse events will be recorded over the 9-month period. Adverse events will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE v5.0).

Time frame
9 months
4

Change in Serum 25(OH) Vitamin D Levels

Time frame
9 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

S.LAB (SOLOWAYS)

Lead sponsor

Center for New Medical Technologies, Novosibirsk, Russia

Collaborator

Source ClinicalTrials.gov
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