NCT07256769 Vitamin k, D-chiro Inositol and α-lactalbumin in Bone Homeostasis
| NCT ID | NCT07256769 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Regina Elena Cancer Institute |
| Condition | Osteoporosis Secondary |
| Study Type | OBSERVATIONAL |
| Enrollment | 134 participants |
| Start Date | 2025-09-29 |
| Primary Completion | 2027-09-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 134 participants in total. It began in 2025-09-29 with a primary completion date of 2027-09-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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®
Eligibility Criteria
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.
Contact & Investigator
Marialuisa Appetecchia, MD
PRINCIPAL INVESTIGATOR
Regina Elena National Cancer Insitute
Frequently Asked Questions
Who can join the NCT07256769 clinical trial?
This trial is open to female participants only, aged 35 Years or older, up to 70 Years, studying Osteoporosis Secondary. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07256769 currently recruiting?
Yes, NCT07256769 is actively recruiting participants. Contact the research team at marialuisa.appetecchia@ifo.it for enrollment information.
Where is the NCT07256769 trial being conducted?
This trial is being conducted at Latina, Italy, Roma, Italy.
Who is sponsoring the NCT07256769 clinical trial?
NCT07256769 is sponsored by Regina Elena Cancer Institute. The principal investigator is Marialuisa Appetecchia, MD at Regina Elena National Cancer Insitute. The trial plans to enroll 134 participants.