Vitamin K2 supplementation for patients with low bone density and a specific gene variant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot clinical trial evaluates the safety and preliminary efficacy of vitamin K2 (menaquinone-7) supplementation in adults aged 40-75 with osteopenia or osteoporosis who carry a specific variant in the vitamin D receptor (VDR) gene. The study compares two groups: those with the VDR variant and those without, to assess improvements in bone mineral density and related biomarkers. Participants will receive vitamin K2 alongside a standard vitamin D3 regimen, with the hypothesis that those with the VDR variant will show greater benefits from the supplementation. The trial aims to provide insights into personalized supplementation strategies for better bone health.

Why it matters

Who can join: the full rules

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's running

• Center For New Medical Technologies
  Novosibirsk, Russia Recruiting

Study contacts

• Study coordinator: Andrei AV Ponomarenko, MD
• Email: dayshadoff@gmail.com
• Phone: +79628316017

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.