Clinical trial for Osteoporosis
Official title A Pilot Study of Vitamin K2 (Menaquinone-7, Soloways ™) in Patients With Osteopenia/Osteoporosis Carrying a VDR Gene Variant
ClinicalTrials.gov ID: NCT06867952
What this study is testing
- What it's testing
- The study wants to find out if taking vitamin K2 is safe and if it can improve bone density and bone‑related blood markers in people with osteopenia or osteoporosis who carry a certain VDR gene variant.
- Who it's for
- Adults with low bone density (osteopenia or osteoporosis) who have the VDR gene variant BsmI or ApaI, or who do not have the variant.
- What's involved
- Participants will take vitamin K2 supplements and have bone density scans and blood tests to measure bone health. They will be grouped by whether they have the gene variant or not.
- Time commitment
- The study lasts about 12 months and includes regular clinic visits for scans, blood tests, and follow‑up assessments.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 75
You may be able to join if
- 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).
You likely can't join if
- Current or recent (last 3 months) use of high-dose bisphosphonates, anabolic agents (e.g., teriparatide), or selective estrogen receptor modulators...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Novosibirsk, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Novosibirsk, Russia. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.