Clinical trial NCT06867952: A Pilot Study of Vitamin K2 (Menaquinone-7, Soloways ™) in Patients With Osteopenia/Osteoporosis Carrying a VDR Gene Variant
Official title: A Pilot Study of Vitamin K2 (Menaquinone-7, Soloways ™) in Patients With Osteopenia/Osteoporosis Carrying a VDR Gene Variant
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoporosis
Osteopenia
Keywords: Osteopenia
Osteoporosis
Supplements
Vitamin K2
Vitamin D
Lead sponsor: S.LAB (SOLOWAYS)
Sponsor class: OTHER
Collaborators: name: Center for New Medical Technologies, Novosibirsk, Russia
First posted: 2025-03-10
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Vitamin D receptor (VDR) polymorphisms have been associated with varying responses to vitamin D and calcium supplementation, ultimately influencing bone health. Menaquinone-7 (vitamin K2) is crucial for carboxylation of osteocalcin, facilitating calcium deposition in bone. This study investigates whether individuals with an "unfavorable" VDR gene variant - who might have lower basal responsiveness to vitamin D - experience enhanced benefit from MK-7 supplementation in conjunction with a standard vitamin D3 regimen. By focusing on this genotype-stratified approach, the study aims to generate preliminary data supporting the role of personalized supplementation strategies in skeletal health.

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.

Primary outcomes:
measure: Change in Bone Mineral Density (BMD)
timeFrame: 9 months
Secondary outcomes:
measure: Change in Serum Osteocalcin Levels
timeFrame: 9 months
measure: Change in Bone Turnover Markers
timeFrame: 9 months
measure: Adverse Events and TolerabilityIncidence of Treatment-Related Adverse Events as Assessed by CTCAE v5.0
timeFrame: 9 months
measure: Change in Serum 25(OH) Vitamin D Levels
timeFrame: 9 months
measure: Change in Patient-Reported Quality of Life as Measured by the Short Form-36 Health Survey (SF-36)
timeFrame: 9 months
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Center For New Medical Technologies
Study officials:
References: