Osteopenia, Osteoporosis
Conditions
Keywords
Osteopenia, Osteoporosis, Supplements, Vitamin K2, Vitamin D
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.
Interventions
DIETARY_SUPPLEMENTVitamin K2 plus vitamin D3
Intervention: Vitamin K2 (menaquinone-7), 100-200 µg/day plus vitamin D3 (800- 1000 IU/day) for 6-9 months.
Sponsors
Center for New Medical Technologies, Novosibirsk, Russia
S.LAB (SOLOWAYS)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Bone Mineral Density (BMD) | 9 months | Assessed by DXA (Dual-Energy X-Ray Absorptiometry) scans |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum Osteocalcin Levels | 9 months | — |
| Change in Bone Turnover Markers | 9 months | 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. |
| Adverse Events and TolerabilityIncidence of Treatment-Related Adverse Events as Assessed by CTCAE v5.0 | 9 months | 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). |
| Change in Serum 25(OH) Vitamin D Levels | 9 months | — |
| Change in Patient-Reported Quality of Life as Measured by the Short Form-36 Health Survey (SF-36) | 9 months | Patient-reported quality of life will be assessed using the Short Form-36 Health Survey (SF-36), which generates two component scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Each score ranges from 0 to 100, with higher scores indicating a better quality of life. The outcomes will be reported as the mean change in the PCS and MCS scores from baseline to 9 months. |
Countries
Russia
Contacts
Primary ContactAndrei AV Ponomarenko, MD
Outcome results
None listed