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Vitamin k, D-chiro Inositol and α-lactalbumin in Bone Homeostasis

Recruitingn/aAges 35 Years - 70 YearsFemaleRegina Elena Cancer Institute
NCT07256769 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

In women with breast cancer undergoing adjuvant hormone therapy, the marked tissue hypoestrogenism induced by therapy with aromatase inhibitors and/or tamoxifen ± GnRH analogues causes a significant acceleration in bone mass loss, with a consequent increased risk of fracture from the first year of therapy. It is therefore essential to start treatment with antiresorptive drugs and calcium and vitamin D supplementation. It has been hypothesized that vitamin K and α-lactalbumin have an effect in improving the absorption of calcium and vitamin D. In addition, vitamin K promotes gamma-carboxylation of osteocalcin, causing its activation and leading to increased incorporation of hydroxyapatite into the bone, resulting in increased calcium uptake from the blood and other tissues. Studies have reported that a combination of alendronate and vitamin K2 can lead to a decrease in the ratio of uncarb

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📋 Eligibility rules (as published)
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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What it tests

  • Group 1: calcium carbonate/cholecalciferol
  • Group 2: Synostea® (calcium carbonate/cholecalciferol/vitamin K/α-lactalbumin/ d-chiro-inositol)
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Where

2 sites
Santa Maria Goretti Hospital
Latina, Italy
Regina Elena National Cancer Institute
Roma, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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