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

Recruiting now

Conditions studied: Osteoporosis Secondary, Breast Cancer Females

In brief

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-chiro-inositol, acts on bone remodeling by blocking the activation of osteoclasts through inhibition of the binding of RANK-L to its receptor present on pre-osteoclasts. Our hypothesis is that the use of the combination of vitamin K, α- lactalbumin, and D-chiro-inositol should improve the intestinal absorption of calcium and vitamin D, increasing the percentage of patients able to normalize serum levels of vitamin D and urinary calcium excretion (as a parameter of adequate calcium intake). This aspect, together with the direct effect of these components on bone remodeling, could enhance the anti-resorptive effect of standard therapy with bisphosphonates, improving the quantitative and qualitative parameters of bone. Therefore, we design a prospective randomized pilot study to assess efficacy of the combination of vitamin K, α-lactalbumin, and D-chiro-inositol, comparing patients with standard therapy and patients treated with Synostea®

Key facts

Study ID: NCT07256769
Run by: Regina Elena Cancer Institute
People needed: 134
Starts: 2025-09-29
Expected to finish: 2028-03-31
Last updated by the study team: 2025-12-01

Who can join

Age: 35 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

Regina Elena National Cancer Institute — Roma, Italy, Italy (enrolling)
Santa Maria Goretti Hospital — Latina, Italy, Italy

Full record on ClinicalTrials.gov

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