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Study identifier: NCT07256769 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Osteoporosis Secondary · Breast Cancer Females  ·  Sponsor: Regina Elena Cancer Institute

PhaseN/A
Planned participants134
Who can joinFemale, 35 Years to 70 Years
Healthy volunteersNo

About this study

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 uncarboxylated osteocalcin to carboxylated osteocalcin, contributing to an increase in BMD, especially in the femoral neck. α-lactalbumin is able to increase the bioaccessibility of calcium due to its ability to prevent its precipitation at the neutral pH present in the absorptive tracts of the small intestine. Furthermore, α- lactalbumin has a binding site for vitamin D3, and the complexes formed by monomers of this protein and vitamin D have shown good stability in the presence of high vitamin concentrations. Inositol is a carbohydrate structurally similar to glucose which, in its isomeric form D-…

This description comes directly from the study's public registry record.

Talk to the study team

Marialuisa Appetecchia, MD  ·  0039 0652666026  ·  marialuisa.appetecchia@ifo.it

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Locations (2)

Santa Maria Goretti HospitalLatina, Italy, ItalyNot Yet Recruiting
Regina Elena National Cancer InstituteRoma, Italy, ItalyRecruiting

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Source record: clinicaltrials.gov/study/NCT07256769