Vitamin K, d‑chiro‑inositol and α‑lactalbumin for protecting bones during breast cancer hormone therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Regina Elena National Cancer Institute
  Roma, Italy, Italy Recruiting
• Santa Maria Goretti Hospital
  Latina, Italy, Italy Not yet 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.