Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT07256769
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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
35 Years
Maximum Age:
70 Years
Study:
NCT07256769
Study Brief:
Protocol Section:
NCT07256769