Vitamin K, d‑chiro‑inositol and α‑lactalbumin for protecting bones during breast cancer hormone therapy
Synergic Role of Vitamin k, D-chiro Inositol and α-lactalbumin in Bone Homeostasis in Breast Cancer Patients Treated With Aromatase Inhibitors
This will test whether adding vitamin K, d‑chiro‑inositol and α‑lactalbumin to calcium and vitamin D better protects bone health in women on hormone therapy for breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 134 (estimated) |
| Ages | 35 Years to 70 Years |
| Sex | Female |
| Sponsor | Regina Elena Cancer Institute Academic / other |
| Locations | 2 sites (Latina, Italy and 1 other locations) |
| Trial ID | NCT07256769 on ClinicalTrials.gov |
What this trial studies
This observational cohort follows women with breast cancer receiving adjuvant hormone therapy who are starting oral alendronate for cancer treatment–induced bone loss. Participants receive either standard calcium carbonate with cholecalciferol or a combined product (Synostea®) that also contains vitamin K, α‑lactalbumin and d‑chiro‑inositol. Investigators will track vitamin D status, markers of osteocalcin carboxylation, bone turnover markers and bone mineral density over time. The goal is to determine whether the Synostea combination improves calcium/vitamin D absorption and bone marker profiles compared with standard supplementation.
Who should consider this trial
Good fit: Caucasian women aged 35–70 with breast cancer who started aromatase inhibitor or tamoxifen ± GnRH therapy within the past 12 months, have vitamin D <30 ng/mL, and are about to start oral alendronate.
Not a fit: Patients with baseline vitamin D above 30 ng/mL, those already on anti‑resorptive therapy, on chronic steroids, with severe renal failure (eGFR <30 ml/min) or uncontrolled diabetes are unlikely to benefit from this supplement comparison.
Why it matters
Potential benefit: If effective, the combination could reduce bone loss and lower fracture risk by improving calcium and vitamin D absorption and activating osteocalcin.
How similar studies have performed: Prior trials combining vitamin K2 with bisphosphonates have shown improved osteocalcin carboxylation and modest BMD gains, but the specific combination including α‑lactalbumin and d‑chiro‑inositol is novel and not well tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Latina, Italy and 1 other locations
- Santa Maria Goretti Hospital — Latina, Italy, Italy (Not_yet_recruiting)
- Regina Elena National Cancer Institute — Roma, Italy, Italy (Recruiting)
Study contacts
- Principal investigator: Marialuisa Appetecchia, MD — Regina Elena National Cancer Insitute
- Study coordinator: Marialuisa Appetecchia, MD
- Email: marialuisa.appetecchia@ifo.it
- Phone: 0039 0652666026
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.