Could vitamin k and inositol help breast cancer patients keep strong bones?

NCT ID NCT07256769

Disease control Sponsor: Regina Elena Cancer Institute Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding vitamin K, α-lactalbumin, and D-chiro-inositol to standard calcium and vitamin D supplements can improve bone health in women with breast cancer who are on hormone therapy. These women are at higher risk for bone loss and fractures. The trial will compare the supplement combination against standard care over 12 months in 134 participants.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Synostea® (calcium carbonate, cholecalciferol, vitamin K, α-lactalbumin, D-chiro-inositol)
What this could lead to: If it works, this could point toward a better supplement combination to protect bone health in breast cancer survivors on hormone therapy.
What could go wrong: This is a small pilot study (134 people) testing a dietary supplement, not a drug. The benefits may be modest, and results may not apply to all patients.

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Study facts

What this study's own registry entry says, in plain language.

Participants

About 134 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult women (aged between 35 and 70) with breast cancer undergoing treatment with aromatase inhibitors or tamoxifen + GnRH analogues or aromatase inhibitors + GnRH analogues, and about to start treatment with oral bone resorption inhibitors (alendronate), and meeting the other criteria

Ages

35 to 70 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * caucasian women aged between 35 and 70; * diagnosed with breast cancer undergoing treatment with aromatase inhibitors or tamoxifen + GnRH analogues or aromatase inhibitors + GnRH analogues not started more than 12 months ago, about to start treatment with oral bone resorption inhibitors (alendronate); * vitamin D levels below 30 ng/ml (test carried out no more than 6 months prior to the baseline/T0 visit) * patients able to comply with the procedures and/or requirements of the study * informed consent to participate in the study and data processing, written personally and/or through a witness, before any study-specific procedure is carried out Exclusion Criteria: * uncontrolled diabetes mellitus (HbA1c 8%), severe CRF (eGFR\<30 ml/min); * patients with primary or secondary hyperparathyroidism due to CRF; * baseline vitamin D levels greater than 30 ng/ml; * patients already being treated with anti-resorptive drugs; * patients undergoing steroid therapy; * patients undergoing treatment with other forms of vitamin D (calcifediol, calcitriol) or who require high doses of calcium (hypoparathyroidism); * patients undergoing treatment with drugs that can affect calcium excretion (diuretics); * inability to comply with the procedures required by the study.

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Conditions

The condition(s) this trial relates to.

breast cancer female breast carcinoma osteoporosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer females Osteoporosis secondary

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

2 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Could vitamin k and inositol help breast cancer patients keep strong bones?

What the study statuses mean