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 @ 5:47 PM
Ignite Modification Date:
2025-12-24 @ 5:47 PM
NCT ID:
NCT03518268
Eligibility Criteria:
Inclusion criteria
1. Age≥ 35 years
2. Breast cancer stages 1-3 (non metastatic)
3. Under treatment with aromatase inhibitors
4. In menopausal status for ≤10y
5. Estrogen receptor positive tumor
6. CTX ≥300 pg/ml
Exclusion criteria
1. Distant metastases
2. Additional active primary malignancy
3. Metabolic bone disease (primary hyperparathyroidism, hyperthyroidism, paget, osteomalacia etc)
4. Glucocorticoid treatment (chronic or high dose \>7.5 mg in the last three months)
5. Bisphosphonate treatment for more than 3 months in the last 2 years
6. Bone densitometry (DXA) T-Score \<-2 unless not a candidate for antiresorptive therapy (unwilling/unable to take treatment)
7. Lactose intolerant subjects
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
35 Years
Study:
NCT03518268
Study Brief:
Protocol Section:
NCT03518268