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:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-25 @ 4:57 AM
NCT ID:
NCT00054418
Eligibility Criteria:
1. Required Characteristics
1. Premenopausal women
* ≤ 6 months since last menstrual period
* no prior bilateral oophorectomy
* not on estrogen replacement therapy
* if TAH is performed, with at least one intact ovary, or if \> 3 months since last menstrual period, then patients must have premenopausal estrogen levels ≤ 1 month of study entry
2. Scheduled to undergo adjuvant or neoadjuvant chemotherapy for primary breast cancer (stages I-IIIB)
3. ≥ 18 years of age
4. ECOG performance status (PS) 0 or 1
2. Contraindications
1. Hypercalcemia (calcium level \> 1mg/dL above UNL ≤ 6 months
2. Hypocalcemia (calcium level \> 0.5 mg/dL below UNL ≤ 6 months
3. Inability to stand or sit upright for at least 30 minutes
4. Known swallowing disorder
5. Bone mineral density T score of ≤ - 2.0 at the hip or lumbar spine
* a patient with a T score of - 2.1 is ineligible
* a patient with a T score of - 1.9 is eligible
6. History of vertebral compression fracture
* Exception: traumatic fracture of the coccyx would not exclude a patient from participation
7. Corticosteroids at doses \> 5 mg daily of prednison or equivalent for \> 2 weeks in the past 6 months
8. Previous treatment with bisphosphonates
9. Diseases affecting bone metabolism (hyperthyroidism, hyperparathyroidism, and hypercortisolism)
10. History of severe renal impairment or creatinine \> 2.0 mg/dL
11. Malabsorption syndrome
12. Estrogen replacement therapy
13. Oral contraceptive use
14. Prior bilateral oophorectomy
15. Pregnant women
* Nursing women
* Women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, injections, intrauterine device \[IUD\], surgical sterilization, abstinence, etc.)
* This study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown
16. Dental extraction, root canal, or implants ≤ 3 months prior to registration or planned during study treatment
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00054418
Study Brief:
Protocol Section:
NCT00054418